RESUMEN
PURPOSE: This study aimed to compare the safety and effectiveness of intraocular pressure reduction between micropulse transscleral cyclophotocoagulation and "slow cook" transscleral cyclophotocoagulation in patients with refractory primary open-angle glaucoma. METHODS: We included patients with primary open angle glaucoma with at least 12 months of follow-up. We collected and analyzed data on the preoperative characteristics and postoperative outcomes. The primary outcomes were a reduction of ≥20% of the baseline value (criterion A) and/or intraocular pressure between 6 and 21 mmHg (criterion B). RESULTS: We included 128 eyes with primary open-angle glaucoma. The preoperative mean intraocular pressure was 25.53 ± 6.40 and 35.02 ± 12.57 mmHg in the micropulse- and "slow cook" transscleral cyclophotocoagulation groups, respectively (p<0.001). The mean intraocular pressure was reduced significantly to 14.33 ± 3.40 and 15.37 ± 5.85 mmHg in the micropulse- and "slow cook" transscleral cyclophotocoagulation groups at the last follow-up, respectively (p=0.110). The mean intraocular pressure reduction at 12 months was 11.20 ± 11.46 and 19.65 ± 13.22 mmHg in the micropulse- and "slow cook" transscleral cyclophotocoagulation groups, respectively (p<0.001). The median preoperative logMAR visual acuity was 0.52 ± 0.69 and 1.75 ± 1.04 in the micropulse- and "slow cook" transscleral cyclophotocoagulation groups, respectively (p<0.001). The mean visual acuity variation was -0.10 ± 0.35 and -0.074 ± 0.16 in the micropulse- and "slow cook" transscleral cyclophotocoagulation, respectively (p=0.510). Preoperatively, the mean eye drops were 3.44 ± 1.38 and 2.89 ± 0.68 drugs in the micropulse- and "slow cook" transscleral cyclophotocoagulation groups, respectively (p=0.017), but those were 2.06 ± 1.42 and 1.02 ± 1.46 at the end of the study in the "slow cook" and micropulse transscleral cyclophotocoagulation groups, respectively (p<0.001). The success of criterion A was not significant between both groups. Compared with 11 eyes (17.74%) in the "slow cook" transscleral cyclophotocoagulation group, 19 eyes (28.78%) in the micropulse transscleral cyclophotocoagulation group showed complete success (p=0.171). For criterion B, 28 (42.42%) and 2 eyes (3.22%) showed complete success after micropulse- and "slow cook" transscleral cyclophotocoagulation, respectively (p<0.001). CONCLUSION: Both techniques reduced intraocular pressure effectively.
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Glaucoma de Ángulo Abierto , Presión Intraocular , Coagulación con Láser , Láseres de Semiconductores , Esclerótica , Humanos , Glaucoma de Ángulo Abierto/cirugía , Glaucoma de Ángulo Abierto/fisiopatología , Presión Intraocular/fisiología , Femenino , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Coagulación con Láser/métodos , Anciano , Láseres de Semiconductores/uso terapéutico , Esclerótica/cirugía , Agudeza Visual , Adulto , Estudios de Seguimiento , Periodo Posoperatorio , Cuerpo Ciliar/cirugía , Factores de TiempoRESUMEN
BACKGROUND: Minimally invasive glaucoma surgery (MIGS) is a new class of surgeries, which combines moderate to high success rates and a high safety profile. Bent Ab interno Needle Goniotomy (BANG) and Gonioscopy-Assisted Transluminal Trabeculotomy (GATT) are two low-cost MIGS procedures that communicate the anterior chamber to Schlemm's canal. Most of the available publications on MIGS are either case series or retrospective studies, with different study protocols. The aim of this manuscript is to describe a randomized clinical trial (RCT) protocol to compare the long-term intraocular pressure (IOP) control and the safety of both procedures in eyes with primary open-angle glaucoma. METHODS: This is a parallel, double-arm, single-masked RCT that includes pseudophakic primary open-angle glaucoma (POAG) eyes. After inclusion criteria, medications will be washed out to verify baseline IOP before surgery. Patients will be randomized to BANG or GATT using a sealed envelope. Follow-up visits will be 1, 7, 15, 30, 60, 90, 180, 330 and 360 days after surgery. On PO330, a new medication washout will be done. The main outcome is the IOP reduction following the procedures. Complimentary evaluation of functional and structural parameters, safety, and quality of life will be done after 30, 90, 180, and 360 days. DISCUSSION: Our study was designed to compare the long-term efficacy and safety of two low-cost MIGS. Most of the published studies on this subject are case series or retrospective cohorts, with different study protocols, which included different types and severities of glaucomas, combined with cataract extraction. Our study only included mild to moderate POAG eyes, with previous successful cataract extraction. Moreover, it provides a standardized protocol that could be replicated in future studies investigating various types of MIGS. This would allow comparison between different techniques in terms of efficacy, safety, and patients' quality of life. TRIAL REGISTRATION: Retrospectively registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) platform RBR-268ms5y . Registered on July 29, 2023. The study was approved by the Ethics Committee of the University of Campinas, Brazil.
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Glaucoma de Ángulo Abierto , Gonioscopía , Presión Intraocular , Ensayos Clínicos Controlados Aleatorios como Asunto , Trabeculectomía , Humanos , Glaucoma de Ángulo Abierto/cirugía , Glaucoma de Ángulo Abierto/fisiopatología , Trabeculectomía/métodos , Trabeculectomía/instrumentación , Resultado del Tratamiento , Método Simple Ciego , Masculino , Femenino , Factores de Tiempo , Persona de Mediana Edad , Agujas , Anciano , AdultoAsunto(s)
Trabeculectomía , Humanos , Trabeculectomía/métodos , Glaucoma/cirugía , Femenino , Masculino , Glaucoma de Ángulo Abierto/cirugíaRESUMEN
PRCIS: Selective laser trabeculoplasty can be used as a substitute for medications in patients with mild-to-moderate glaucoma, reducing the cost of eye drop distribution in the Brazilian public health system. PURPOSE: To observe the effectiveness of selective laser trabeculoplasty (SLT) as a substitute for eye drops in patients with open angle glaucoma in the Brazilian Public Health System. MATERIALS AND METHODS: SLT was performed bilaterally after medication washout. This is a prospective interventional study comparing intraocular pressure (IOP) when using eye drops at baseline (post-washout), and at 12-month follow-up after SLT. Medication was added if the target IOP was not achieved, following the Brazilian Public Health System eye drops protocol, based on medication costs. Absolute (without eye drops) and qualified (with eye drops) success were measured with IOP ≤ 21, IOP ≤ 18, IOP ≤ 15 and IOP ≤ 12 mm Hg. Besides IOP evolution, the ability to reduce IOP (in %), and eye drops reduction were evaluated. RESULTS: Ninety-two eyes of 46 patients were included, 70 eyes with mild glaucoma and 22 with moderate glaucoma; the mean number of eye drops was 2.26±1.06 (82.6% were using a prostaglandin analogue), and post-washout IOP of 21.10±5.24 mm Hg. There was relative success at IOP ≤18 mm Hg, where the mild group had greater success than the moderate group (88.1% vs. 71.4%, P =0.824). The average IOP reductions were 23.04% and 25.74% at 6 and 12 months, respectively. The average number of eye drops was 1.02, with 1.1% using a prostaglandin analogue. Furthermore, 68.19% of the patients had a decrease in the quantity of eye drops used. CONCLUSION: SLT is effective in reducing IOP and replacing eye drops in patients in the Brazilian Public Health System. Moreover, there was a significant reduction in the use of prostaglandin analogues.
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Antihipertensivos , Glaucoma de Ángulo Abierto , Presión Intraocular , Terapia por Láser , Soluciones Oftálmicas , Tonometría Ocular , Trabeculectomía , Humanos , Trabeculectomía/métodos , Presión Intraocular/fisiología , Estudios Prospectivos , Femenino , Glaucoma de Ángulo Abierto/cirugía , Glaucoma de Ángulo Abierto/fisiopatología , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Masculino , Terapia por Láser/métodos , Brasil , Anciano , Persona de Mediana Edad , Antihipertensivos/administración & dosificación , Antihipertensivos/uso terapéutico , Resultado del Tratamiento , Programas Nacionales de SaludRESUMEN
We assessed the effects of anti-inflammatory treatment after selective laser trabeculoplasty through a systematic search of the MEDLINE, COCHRANE, and ClinicalTrials.gov. The outcome measures were intraocular pressure, anterior chamber inflammation, and discomfort. Evidence synthesis was performed using fixed effects or random-effects model according to the heterogeneity of the included studies. Heterogeneity was assessed using Q-statistic and I2. For an overall estimate of continuous outcomes, the mean differences and their 95% confidence intervals were applied, while odds ratios and their 95% confidence intervals were applied for dichotomous outcomes. Six studies were included in all. No significant difference was noted in the patients for intraocular pressure and discomfort when treated with anti-inflammatory drops. However, the patients showed benefit from reduced anterior chamber inflammation in the first postoperative week [FE OR=0.43, 95% CI=(0.19, 0.95), PQ=0.97, I2=0%], with no significant difference between the outcomes of non-steroidal anti-inflammatory drugs and steroids [FE OR=0.75, 95% CI=(0.20, 2.82), PQ=0.37, I2=0%]. Anti-inflammatory drops reduce anterior chamber inflammation after selective laser trabeculoplasty but showed no effect on the intraocular pressure.
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Glaucoma de Ángulo Abierto , Trabeculectomía , Humanos , Trabeculectomía/efectos adversos , Glaucoma de Ángulo Abierto/cirugía , Antiinflamatorios/uso terapéutico , Inflamación/tratamiento farmacológico , Inflamación/cirugía , Rayos LáserRESUMEN
INTRODUCTION/PURPOSE: The aim of this study was to compare two surgical revision techniques in failed trabeculectomies after 6 months. METHODS: Patients diagnosed with open-angle glaucoma who underwent trabeculectomy in at least one eye with uncontrolled intraocular pressure (IOP) after trabeculectomy performed at least 6 months before were enrolled in this prospective trial. All participants underwent a complete ophthalmological examination at baseline. Randomization was performed to one eye per patient to double-masked trabeculectomy revision or needling. Patients were examined on the first day, 7 days, 14 days, and then monthly until completing 1 year after surgical intervention. All follow-up visits included the following: patients reported ocular and systemic events, best-corrected visual acuity, IOP, slit-lamp examination, and optic disc evaluation for cup-to-disc ratio. Gonioscopy and stereoscopic optic disc photographs were taken at baseline and 12 months. After 1-year, the IOP and number of medications were compared between the groups. Absolute success criteria in the study were IOP <16 mm Hg, for 2 consecutive measurements without using a hypotensive medication. RESULTS: Forty patients were included in this study. Among them, 38 completed 1-year follow-up (18 in revision group and 20 in needling group). The age ranged from 21 to 86 years, with a mean of 66.82 ± 13.44. At baseline, the average IOP was 21.64 ± 5.12 mm Hg (range from 14 to 38 mm Hg) in the entire group. All patients were using at least two classes of hypotensive eye drops, and 3 patients were using oral acetazolamide. The mean use of hypotensive eye drop medications was 3.11 ± 0.67 at the baseline for the entire group. In the present study, 58% of the patients presented complete success, 18% qualified success, and 24% failed in both groups. After 1-year treatment, both techniques were similar for IOP parameters and also for number of medications (p = 0.834 and p = 0.433, respectively). Regarding intra- or postoperative complications, one patient in each group needed a new surgical intervention, one in the needling group due to shallow anterior chamber and one in the revision group due to spontaneous Seidel sign, and one patient in the needling group underwent posterior revision due to fail. CONCLUSIONS: Both techniques were safe and effective for IOP control after 1 year of follow-up in patients who underwent to trabeculectomy more than 6 months before.
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Glaucoma de Ángulo Abierto , Trabeculectomía , Humanos , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Glaucoma de Ángulo Abierto/cirugía , Estudios Prospectivos , Presión Intraocular , Trabeculectomía/métodos , Tonometría Ocular , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
This study was designed to compare the efficacy of selective laser trabeculoplasty (SLT) and micropulse laser trabeculoplasty (MLT) in patients with primary open angle glaucoma (POAG) requiring additional IOP control. In this retrospective, comparative study, we reviewed the charts of POAG patients requiring additional IOP lowering, who underwent either SLT or MLT and were followed for at least one year. We evaluated mean intraocular pressure (IOP), mean IOP reduction from baseline and mean number of glaucoma medications 1, 3, 6 and 12 months after treatment. Success rates (success defined as IOP ≤ 21 mmHg and ≥ 20% reduction from baseline IOP without additional medications, new laser session, or glaucoma surgery) at one year were also compared. A total of 98 POAG patients were included, 52 individuals in the SLT group and 46 in the MLT group. Laser treatment resulted in significant mean IOP reductions from baseline in both groups (SLT = -6.0 ± 3.3 mmHg (24.9%) and MLT = -5.8 ± 2.6 mmHg (23.4%)) (p < 0.001). However, there was no statistically significant difference between the mean IOP reductions in both groups (p = 0.74). At 12 months, the mean number of glaucoma medications was significantly smaller in the SLT group (1.17 + 0.4) when compared to the MLT group (2.21 + 0.2) (p = 0.001). Additionally, after 12 months, success was obtained in 32 (61.5%) SLT cases compared to 27 (58.7%) MLT-treated eyes (p = 1.0). MLT and SLT are both effective in controlling the IOP in POAG patients requiring additional IOP reduction. However, after 12 months, SLT demonstrated a greater efficacy in reducing medication burden when compared to MLT.Trial registration: CEP/CONEP/MS Brazil 40948620.9.0000.5600.
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Glaucoma de Ángulo Abierto , Glaucoma , Terapia por Láser , Láseres de Estado Sólido , Trabeculectomía , Humanos , Presión Intraocular , Trabeculectomía/métodos , Glaucoma de Ángulo Abierto/cirugía , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Estudios Retrospectivos , Glaucoma/cirugía , Terapia por Láser/métodos , Láseres de Estado Sólido/uso terapéutico , Resultado del TratamientoRESUMEN
PRCIS: This retrospective case series of patients with open angle glaucoma and prior trabeculectomy or tube shunt surgery found that selective laser trabeculoplasty (SLT) resulted in significant intraocular pressure (IOP) reductions in the intermediate follow-up period in select cases. PURPOSE: The purpose of this study was to assess the IOP-lowering effect and tolerability of SLT after prior trabeculectomy or tube shunt surgery. MATERIALS AND METHODS: Open angle glaucoma patients at Wills Eye Hospital who previously underwent incisional glaucoma surgery and subsequently received SLT between 2013 and 2018 were included, along with an age-matched control group. Baseline characteristics, procedural data, and post-SLT data were recorded at 1, 3, 6, 12 months, and most recent visit. The primary success of SLT treatment was defined as IOP reduction of 20% or greater without the use of additional glaucoma medications compared to pre-SLT IOP. Secondary success was defined as IOP reduction ≥20% with the use of additional glaucoma medications compared to pre-SLT IOP. RESULTS: There were 45 eyes in the study group and 45 eyes in the control group. In the study group, IOP decreased from a baseline of 19.5±4.7 mm Hg on 2.2±1.2 medications to 16.7±5.2 mm Hg ( P =0.002) on 2.2±1.1 glaucoma medications ( P =0.57). In the control group, IOP decreased from 19.5±4.2 mm Hg on 2.4±1.0 medications to 16.4±5.2 mm Hg ( P =0.003) on 2.1±1.3 medications ( P =0.36). There was no difference in IOP reduction or change in number of glaucoma medications after SLT at any postoperative visit between the 2 groups ( P ≥0.12 for all). Primary success rates at 12 months were 24.4% for the control group and 26.7% for the prior incisional glaucoma surgery group with no significant difference between the groups ( P =0.92). There were no persistent complications after SLT treatment in either group. CONCLUSION: SLT may effectively lower IOP in patients with open angle glaucoma who have had previous incisional glaucoma surgery and should be considered in select cases.
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Glaucoma de Ángulo Abierto , Glaucoma , Terapia por Láser , Hipotensión Ocular , Trabeculectomía , Humanos , Trabeculectomía/métodos , Glaucoma de Ángulo Abierto/cirugía , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Presión Intraocular , Estudios Retrospectivos , Glaucoma/cirugía , Malla Trabecular/cirugía , Terapia por Láser/métodos , Hipotensión Ocular/cirugía , Rayos Láser , Resultado del TratamientoRESUMEN
PURPOSE: To evaluate the efficacy of micropulse transscleral cyclophotocoagulation (MP-TSCPC) considering different characteristics: glaucoma subtypes and lens status. METHODS: A retrospective case-series study was designed to evaluate intraocular pressure (IOP), and the number of IOP-lowering medications, used by glaucoma patients treated with MP-TSCPC between 2016 and 2019. Cases had a follow-up period of 12 months. Achieving an IOP reduction higher than 20%, or the decrease of at least one IOP-lowering medication, was considered a successful outcome. The same population was analyzed by classifying them in two groups as: glaucoma subtypes and lens status. The baseline spherical equivalent (SE) was also calculated for considering association with the achieved IOP. RESULTS: A total of 86 eyes were included. In most cases, IOP and IOP-lowering medications were decreased with a statistically significant difference (p < 0.0001), and all of them had a successful outcome. The percentage of IOP drop oscillated between 25.9% (open-angle glaucoma sub-group) and 37.5% (pseudoexfoliative glaucoma sub-group), 12 months after surgery. The difference between the groups was not statistically significant (p 0.20 and 0.32 for glaucoma subtypes and lens status, respectively). The Pearson's coefficient obtained was low for the SE and IOP association, at the 12 -month postoperative mark (- 0.009; p < 0.001). CONCLUSIONS: The MP-TSCPC treatment was successful in decreasing IOP and IOP-lowering medications, in different glaucoma subtypes. Differences between groups (glaucoma subtypes, phakic and pseudophakic eyes) were not statistically significant. No association was found between the SE and the IOP achieved value after MS-TSCPC treatment.
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Glaucoma de Ángulo Abierto , Glaucoma , Errores de Refracción , Humanos , Glaucoma de Ángulo Abierto/cirugía , Glaucoma de Ángulo Abierto/etiología , Estudios Retrospectivos , Láseres de Semiconductores/uso terapéutico , Resultado del Tratamiento , Coagulación con Láser , Agudeza Visual , Glaucoma/cirugía , Glaucoma/etiología , Presión Intraocular , Errores de Refracción/etiología , Cuerpo Ciliar/cirugíaRESUMEN
PURPOSE: Compare 12-month (12 M) safety and efficacy of endoscopic cyclophotocoagulation (ECP) + cataract surgery (Group 1) versus ECP + cataract surgery + iStent inject trabecular micro-bypass implantation (Group 2) in Brazilian patients with open-angle glaucoma (OAG). METHODS: This prospective, multicenter, comparative case series included patients with OAG and cataract who were randomized to receive treatment in Group 1 or Group 2. Outcomes included mean and percent reduction versus preoperative in intraocular pressure (IOP) and number of glaucoma medications; visual acuity; occurrence of adverse events; and rate of secondary surgeries. RESULTS: Preoperatively, Groups 1 and 2 had similar mean IOP (mean ± standard deviation 22.1 ± 3.6 and 22.0 ± 2.5 mmHg, respectively) and mean number of medications (3.3 ± 0.6 and 3.4 ± 0.6 medications, respectively). At all follow-up timepoints through 12 M, both groups achieved significant IOP and medication reductions versus preoperative (IOP p < 0.001 and number of medications p < 0.001 for both groups). At 12 M, IOP reductions were 24.2% (Group 1) and 43.6% (Group 2) (p < 0.001); mean medication reductions were 50.2% and 71.5%, respectively. Mean postoperative IOP and number of medications were higher in Group 1 than Group 2 (IOP p < 0.01 all visits, medication p < 0.01 at 6 M and 12 M). Adverse events were generally mild and infrequent in both groups. CONCLUSION: Both treatment groups (ECP + phacoemulsification, with/without iStent inject implantation) achieved significant and safe reductions in IOP and medications versus preoperative in Brazilian OAG patients. Percent reductions were significantly greater, and mean IOP and medications were significantly lower, in the group receiving iStent inject. CLINICAL TRIAL REGISTRATION (CTR): CAAE project identification #20053019.5.0000.5078. Protocol #3.587.147. Clinical Trial Database of the Federal University of Goiás, Brazil. Registration Date: September 19, 2019.
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Catarata , Glaucoma de Ángulo Abierto , Glaucoma , Facoemulsificación , Humanos , Glaucoma de Ángulo Abierto/complicaciones , Glaucoma de Ángulo Abierto/cirugía , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Brasil/epidemiología , Estudios Prospectivos , Glaucoma/cirugía , Presión Intraocular , Catarata/complicacionesRESUMEN
PURPOSE: The nasal sector of the anterior chamber angle may present a higher density of collector channels, which may influence the results of angle surgeries. Considering the anatomical differences in the anterior chamber angle, we compared the results of the nasal and temporal 180° selective laser trabeculoplasty approaches for open-angle glaucoma. METHODS: A retrospective chart review was conducted for patients with open-angle glaucoma (primary, pseudoexfoliation, and pigmentary) who underwent at least one 180° selective laser trabeculoplasty session between December 2016 and October 2018. The nasal (N1) or temporal (T1) sectors were chosen at the physician's discretion. Patients who did not experience decreased intraocular pressure between 3 and 6 months again underwent 180° selective laser trabeculoplasty in the opposite angle sector (T2 and N2). The main outcome measured was decrease in intraocular pressure at 6-month follow-up, after the last selective laser trabeculoplasty. A multivariable regression analysis was used to evaluate factors associated with decreased intraocular pressure after treatment. RESULTS: The procedure was performed initially in 45 eyes (N1, 25; T1, 20 eyes) and repeated in the opposite anterior chamber angle sector in 19 eyes (N2, 11; T2, 8 eyes). Analysis of variance revealed that only the N1 approach presented a significant difference in the decrease in intraocular pressure as compared with the T1, N2, and T2 approaches (p=0.0014). The baseline intraocular pressure (p=0.021) and anterior chamber angle sector (N1; p=0.044) correlated with decreased intraocular pressure. CONCLUSION: Compared with the temporal approach, 180° selective laser trabeculoplasty performed initially in the nasal sector was associated with a more significant decrease in intraocular pressure. Considering the sectorial differences in the anterior chamber angle, further prospective trials are warranted to confirm our findings and provide more-efficient selective laser trabeculoplasty protocols.
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Glaucoma de Ángulo Abierto , Terapia por Láser , Trabeculectomía , Humanos , Glaucoma de Ángulo Abierto/cirugía , Estudios Retrospectivos , Presión Intraocular , Terapia por Láser/métodos , Rayos Láser , Resultado del TratamientoRESUMEN
PURPOSE: To assess the outcomes of the trabecular bypass as replacement therapy for medications in pharmacologically controlled vs. pharmacologically uncontrolled open-angle glaucoma patients. METHODS: This was a retrospective study of eyes treated with first- (iStent) or second-generation (iStent inject) trabecular bypass. Group 1 consisted of eyes with pharmacologically controlled intraocular pressure <18 mmHg and Group 2 consisted of eyes with pharmacologically controlled intraocular pressure ≥18 mmHg. The main outcomes measured were qualified (with or without medications) and unqualified or complete (without medications) success rates at different target intraocular pressures, mean reduction (%) in medication use, and proportion of medication-free eyes. RESULTS: The mean age was 70.4 years in Group 1 (n=105) and 68.1 years in Group 2 (n=65). Qualified success rates for intraocular pressure <18 mmHg, intraocular pressure <15 mmHg, and intraocular pressure <12 mmHg were similar between the groups (Group 1: 96.2%, 88.6%, and 32.4%, respectively; Group 2: 93.8%, 78.5%, and 21.5%, respectively; all p>0.05). Complete success rates were significantly higher in Group 1 than in Group 2: for intraocular pressure <18 mmHg (76.2% vs. 47.7%), intraocular pressure <15 mmHg (73.3% vs. 40.0%), and intraocular pressure <12 mmHg (14.3% vs. 4.6%). The mean reduction in medication use was higher in Group 1 than in Group 2. At the end of follow-up, 79.0% of eyes in Group 1 and 47.7% of eyes in Group 2 became medication-free. CONCLUSIONS: Both groups showed high qualified success rates, but eyes with baseline pharmacologically controlled intraocular pressure <18 mmHg showed higher complete success rates and greater chances of achieving no need for medications.
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Glaucoma de Ángulo Abierto , Humanos , Anciano , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Glaucoma de Ángulo Abierto/cirugía , Estudios Retrospectivos , Malla Trabecular/cirugía , Presión Intraocular , Tonometría OcularRESUMEN
BACKGROUND: Open-angle glaucoma (OAG) is an important cause of blindness worldwide. Laser trabeculoplasty, a treatment modality, still does not have a clear position in the treatment sequence. OBJECTIVES: To assess the effects of laser trabeculoplasty for treating OAG and ocular hypertension (OHT) when compared to medication, glaucoma surgery or no intervention. We also wished to compare the effectiveness of different laser trabeculoplasty technologies for treating OAG and OHT. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2021, Issue 10); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; LILACS, ClinicalTrials.gov and the WHO ICTRP. The date of the search was 28 October 2021. We also contacted researchers in the field. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing laser trabeculoplasty with no intervention, with medical treatment, or with surgery in people with OAG or OHT. We also included trials comparing different types of laser trabeculoplasty technologies. DATA COLLECTION AND ANALYSIS: We used standard methods expected by Cochrane. Two authors screened search results and extracted data independently. We considered the following outcomes at 24 months: failure to control intraocular pressure (IOP), failure to stabilise visual field progression, failure to stabilise optic neuropathy progression, adverse effects, quality of life, and costs. We graded the 'certainty' of the evidence using GRADE. MAIN RESULTS: We included 40 studies (5613 eyes of 4028 people) in this review. The majority of the studies were conducted in Europe and in the USA. Most of the studies were at risk of performance and/or detection bias as they were unmasked. None of the studies were judged as having low risk of bias for all domains. We did not identify any studies of laser trabeculoplasty alone versus no intervention. Laser trabeculoplasty versus medication Fourteen studies compared laser trabeculoplasty with medication in either people with primary OAG (7 studies) or primary or secondary OAG (7 studies); five of the 14 studies also included participants with OHT. Six studies used argon laser trabeculoplasty and eight studies used selective laser trabeculoplasty. There was considerable clinical and methodological diversity in these studies leading to statistical heterogeneity in results for the primary outcome "failure to control IOP" at 24 months. Risk ratios (RRs) ranged from 0.43 in favour of laser trabeculoplasty to 1.87 in favour of medication (5 studies, I2 = 89%). Studies of argon laser compared with medication were more likely to show a beneficial effect compared with studies of selective laser (test for interaction P = 0.0001) but the argon laser studies were older and the medication comparator group in those studies may have been less effective. We considered this to be low-certainty evidence because the trials were at risk of bias (they were not masked) and there was unexplained heterogeneity. There was evidence from two studies (624 eyes) that argon laser treatment was associated with less failure to stabilise visual field progression compared with medication (7% versus 11%, RR 0.70, 95% CI 0.42 to 1.16) at 24 months and one further large recent study of selective laser also reported a reduced risk of failure at 48 months (17% versus 26%) RR 0.65, 95% CI 0.52 to 0.81, 1178 eyes). We judged this outcome as moderate-certainty evidence, downgrading for risk of bias. There was only very low-certainty evidence on optic neuropathy progression. Adverse effects were more commonly seen in the laser trabeculoplasty group including peripheral anterior synechiae (PAS) associated with argon laser (32% versus 26%, RR 11.74, 95% CI 5.94 to 23.22; 624 eyes; 2 RCTs; low-certainty evidence); 5% of participants treated with laser in three studies of selective laser group had early IOP spikes (moderate-certainty evidence). One UK-based study provided moderate-certainty evidence that laser trabeculoplasty was more cost-effective. Laser trabeculoplasty versus trabeculectomy Three studies compared laser trabeculoplasty with trabeculectomy. All three studies enrolled participants with OAG (primary or secondary) and used argon laser. People receiving laser trabeculoplasty may have a higher risk of uncontrolled IOP at 24 months compared with people receiving trabeculectomy (16% versus 8%, RR 2.12, 95% CI 1.44 to 3.11; 901 eyes; 2 RCTs). We judged this to be low-certainty evidence because of risk of bias (trials were not masked) and there was inconsistency between the two trials (I2 = 68%). There was limited evidence on visual field progression suggesting a higher risk of failure with laser trabeculoplasty. There was no information on optic neuropathy progression, quality of life or costs. PAS formation and IOP spikes were not reported but in one study trabeculectomy was associated with an increased risk of cataract (RR 1.78, 95% CI 1.46 to 2.16) (very low-certainty evidence). AUTHORS' CONCLUSIONS: Laser trabeculoplasty may work better than topical medication in slowing down the progression of open-angle glaucoma (rate of visual field loss) and may be similar to modern eye drops in controlling eye pressure at a lower cost. It is not associated with serious unwanted effects, particularly for the newer types of trabeculoplasty, such as selective laser trabeculoplasty.
Asunto(s)
Glaucoma de Ángulo Abierto , Glaucoma , Hipertensión Ocular , Enfermedades del Nervio Óptico , Trabeculectomía , Argón/uso terapéutico , Glaucoma/cirugía , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Glaucoma de Ángulo Abierto/cirugía , Humanos , Hipertensión Ocular/etiología , Hipertensión Ocular/cirugía , Enfermedades del Nervio Óptico/etiología , Enfermedades del Nervio Óptico/cirugía , Trabeculectomía/efectos adversos , Trabeculectomía/métodosRESUMEN
PRCIS: Kahook Dual Blade (KDB) goniotomy can successfully lower intraocular pressure in some patients with uveitis-associated ocular hypertension or glaucoma. PURPOSE: The purpose of this study was to report a case series of patients that underwent KDB goniotomy at a single institution for uveitis-associated ocular hypertension or glaucoma with an open angle. METHODS: We performed a retrospective chart review of all patients with uveitis-associated ocular hypertension or glaucoma who underwent KDB goniotomy with trabecular meshwork excision alone or in combination with phacoemulsification cataract surgery at a single center between August 2017 and February 2020. The case series included 45 eyes of 37 patients. All eyes developed ocular hypertension refractory to maximum-tolerated medical therapy and required surgical intervention. Two eyes were excluded as they were lost to follow-up before 5 months postoperatively. Surgical success was defined as reaching the goal intraocular pressure or lower for each patient, including ongoing medical therapy. RESULTS: At most recent follow-up, 25 (55.6%) of 45 eyes had an intraocular pressure that was at goal. Mean follow-up time was 15.2±12.1 months ranging from 0.5 to 36 months postoperatively, considering that patients were eliminated from the data analysis once they required a second surgery. The mean number of preoperative medications, including oral carbonic anhydrase inhibitors was 3.7±1.2 medications. The mean number of postoperative medications through the last clinic visit was 2.5±1.9 medications for a mean reduction of 1.2±1.6 medications ( P -value <0.0001*). CONCLUSIONS: This larger case series shows that some patients with uveitis-associated ocular hypertension or glaucoma with an open angle may have success with KDB goniotomy.
Asunto(s)
Glaucoma de Ángulo Abierto , Glaucoma , Hipertensión Ocular , Trabeculectomía , Uveítis , Humanos , Glaucoma de Ángulo Abierto/complicaciones , Glaucoma de Ángulo Abierto/cirugía , Presión Intraocular , Estudios Retrospectivos , Resultado del Tratamiento , Glaucoma/cirugía , Hipertensión Ocular/etiología , Hipertensión Ocular/cirugía , Uveítis/complicaciones , Uveítis/diagnóstico , Uveítis/cirugíaRESUMEN
Purpose: The main purpose of this study was to report a case of cystoid macular edema (CME) after gonioscopy-assisted transluminal trabeculotomy (GATT). Methods: We describe the case of a 73-year-old woman with ocular hypertension and history of cataract surgery combined with posterior vitrectomy and epiretinal membrane peeling 2 years before, who developed CME after uncomplicated GATT procedure. Results: Uneventful GATT surgery was performed in an eye with ocular hypertension. A month after GATT surgery, the patient com-plained of blurry vision. Best corrected visual acuity had deteriorated from 20/20 on Snellen chart, to 20/70. The patient was diagnosed with CME. Treatment with topical non-steroidal anti-inflammatory drug (NSAID) and topical corticosteroids for one month, and oral carbonic anhydrase inhibitor for one week achieved a total CME regression with recovery of a normal macular and foveal architecture. Conclusions: Surgery-induced CME may occur following stand-alone microinvasive glaucoma surgery (MIGS) such as GATT. It would be worthwhile to conduct studies to explore whether the prophylactic use of NSAID and corticosteroids is justified.
Asunto(s)
Glaucoma de Ángulo Abierto , Edema Macular , Hipertensión Ocular , Trabeculectomía , Corticoesteroides/efectos adversos , Anciano , Antiinflamatorios no Esteroideos , Femenino , Estudios de Seguimiento , Glaucoma de Ángulo Abierto/complicaciones , Glaucoma de Ángulo Abierto/diagnóstico , Glaucoma de Ángulo Abierto/cirugía , Gonioscopía , Humanos , Presión Intraocular , Edema Macular/etiología , Estudios Retrospectivos , Trabeculectomía/efectos adversos , Trabeculectomía/métodosRESUMEN
INTRODUCCIÓN El glaucoma, se trata de una neuropatía óptica multifactorial cuyo principal factor de riesgo es el aumento de la presión intraocular (PIO) que conlleva a una afectación progresiva del nervio óptico, que se traduce en una altera- ción característica de la cabeza del nervio óptico y en un deterioro del campo visual. El Glaucoma primario de ángulo abierto (GPAA) o glau- coma crónico simple es el tipo de glaucoma más frecuente. El objetivo del tratamiento del glaucoma se basa en la disminución de la PIO, con la finali- dad de prevenir el daño al nervio óptico o la progresión del mismo, inicial- mente se basa en el tratamiento farmacológico, cuando no se consigue el control con fármacos, se indica tratamiento quirúrgico. La trabeculectomía es la técnica de cirugía filtrante antiglaucomatosa perforante considerada de primera elección en el tratamiento del GPAA. La Esclerectomía pro- funda no perforante (EPNP) se propone como alternativa de tratamiento, sugiriendo que al no ser preciso abrir la cámara anterior ocular pueda pre- sentar menos complicaciones que la trabeculectomía. OBJETIVOS Evaluar y comparar la eficacia, la efectividad, la seguridad y el uso de recur- sos del tratamiento quirúrgico del GPAA mediante la técnica quirúrgica de la EPNP con el tratamiento estándar (trabeculectomía). Y describir las preferencias de los pacientes respecto a estas opciones de tratamiento del GPAA e impacto en la calidad de vida de los pacientes. METODOLOGÍA La metodología que se ha seguido en el desarrollo del informe ha sido la metodología GRADE, siguiendo sus directrices se ha llevado a cabo la priorización de la importancia relativa de los desenlaces (variables de resul- tado), en la que han participado dos oftalmólogos expertos en glaucoma. Se diseñó la estrategia de búsqueda en las bases de datos Pubmed (medline), Embase, Web of Science, CINAHL, Psycinfo, centradas en la evaluación de la EPNP y la trabeculectomía (TE) como tratamiento del GPAA. Los estu- dios que cumplían los criterios de inclusión fueron seleccionados. Para dar respuesta sobre la eficacia, efectividad, seguridad y uso de recursos, se extra- jeron los resultados de los estudios relacionados con aspectos del diseño de estudio, la población de estudio, la intervención y su comparación, así como de los desenlaces priorizados.Debido a que se identifican diferentes estrategias de tratamiento del GPAA que son comparadas, se procede a realizar un análisis estratificado por tipo de intervención. Se identifican 8 tipos de comparaciones, de las que se dispone de evidencia para su análisis en 6 de ellas. RESULTADOS Los desenlaces priorizados clasificados como clave o importante, se clasifi- caron en función del dominio de evaluación: eficacia o efectividad, seguri- dad y uso de recursos. Se seleccionaron 17 estudios para realizar la síntesis cuantitativa para dar respuesta a estos dominios de evaluación. Por diseño de estudio se trata de 8 Ensayos Clínicos Aleatorizados (ECA), 5 ensayos clínicos no aleatorizados (ECNA) y 4 estudios observacionales. EFICACIA-EFECTIVIDAD: La PIO post-intervención se reduce tras la cirugía del GPAA. Se observan diferencias estadísticamente significativas entre la EPNP frente a la TE a los 12 y 24 meses. La magnitud de la diferencia entre grupos a favor de la TE a los 12 meses es de 1,63 mmHg (IC95%:0,25 a 3) y de 2,06 mmHg (IC95%:1,21 a 2,9) a los 24 meses. Con la colocación de implante durante la EPNP, se observan diferencias estadísticamente significativas a favor de la TE, siendo la magnitud de la diferencia de 1,42 mmHg (IC95%:0,28 a 2,56). No es posible establecer qué estrategia de tratamiento es más eficaz res- pecto a las tasas de éxito completo y parcial alcanzadas a los 12 y 24 meses. El impacto en la agudeza visual (AV) es variable en función de la estrategia que se comparan, sin poder establecer qué tipo de tratamiento se relaciona con mejor pronóstico visual. SEGURIDAD: La EPNP con colocación de implante es la estrategia que presenta menos complicaciones de hipotalamia y de desprendimiento coroideo tras la ciru- gía respecto a la TE. La magnitud del efecto para la presencia de cámara anterior aplanada es RR=0,08 (IC95%: 0,01 a 0,60) (p=0,01) y de despren- dimiento coroideo es de RR=0,19 (IC95%: 0,06 a 0,59); (p=0,0004).La presencia de desprendimiento coroideo tras la EPNP sin implante y la EPNP con mitomicina C, es menor, al no describirse ningún caso que la observada con la TE. La magnitud del efecto a favor de la EPNP es de RR=0,08 (IC95%:0,01 a 0,62); (p=0,02) y a favor de la EPNP con mitomici- na C es de RR= 0,11 (IC95%:0,01 a 0,85 (p=0,02)En esta revisión pocos son los eventos descritos que se relacionan con complicaciones graves como la endoftalmitis, la blebitis o la maculopatía por hipotonía, sin observar diferencias estadísticamente significativas entre las opciones de tratamiento del GPAA evaluadas. Se describe durante el seguimiento un ojo con endoftamitis, un ojo con blebitis y dos presentan maculopatía por hipotonía. USO DE RECURSOS El número de fármacos asociados tras la cirugía del GPAA se reduce en todas las estrategias de tratamiento analizadas. No es posible establecer la técnica de tratamiento quirúrgico del GPAA que implica administrar menos inyecciones subconjuntivales de 5-Fluoruracilo durante el seguimiento. PREFERENCIA DE LOS PACIENTES ENTRE OPCIONES DE TRATAMIENTO GPAA No han podido ser establecidas las preferencias de los pacientes entre opciones de tratamiento del GPAA y conocer su impacto en la calidad de vida. Sin embargo, los desenlaces priorizados en este informe, de manera indirecta si tienen en cuenta y evalúan el impacto y la repercusión de la cirugía en la calidad de vida de los pacientes.La población de estudio incluida en la revisión es representativa y válida para evaluar los resultados de la cirugía del GPAA globalmente, aunque en alguna de las comparaciones entre EPNP y TE identificadas, en la población de estudio se incluyen algunos ojos intervenidos con otros tipos de glaucoma.Existe una marcada falta de evidencia relacionada principalmente con la EPNP con colocación de implante y mitomicina C durante el proce- dimiento, respecto a su eficacia o efectividad y seguridad. Es importante destacar, que la eficacia y seguridad de los implantes colocados durante la EPNP objeto de evaluación en este informe (Heala- flow, Ologen, Esnoper V-2000, Esnoper-Clip) no ha podido ser establecido, al no identificarse estudios que los evaluaran y comparen con la cirugía estándar del GPAA.Todo esto, hace que sea preciso llevar a cabo investigaciones futuras con un diseño de estudio con grupo de comparación, que englobe un tama- ño muestral apropiado que comparen la EPNP con la TE y específicamente sean reevaluados estos implantes. CONCLUSIONES Las intervenciones de tratamiento quirúrgico del GPAA analizadas redu- cen la PIO con resultados clínicos heterogéneos a lo largo del tiempo, sin que se pueda definir claramente la seguridad de unas respecto a otras.
INTRODUCTIONGlaucoma is a multifactorial optic neuropathy whose main risk factor is the increase in intraocular pressure (IOP) that leads to a progressive worsening of the optic nerve, which in turn entails a characteristic alteration of the head of the optic nerve and a deterioration of the visual field. Primary Open-Angle Glaucoma (POAG) or simple chronic glaucoma is the most common type of glaucoma. This glaucoma treatment's aim is based on the decrease of IOP, in order to prevent damage to the optic nerve or its pro- gression, initially it takes the form of pharmacological treatment, when pharmacological control is not achieved, surgical treatment is advisable. Trabeculectomy is the technique of perforating antiglaucomatous filtering surgery considered first choice in the treatment of POAG. Non-penetrating deep sclerectomy (NPDS) is proposed as an alternative treatment, sugges- ting that since it is not necessary to open the anterior ocular chamber, it may result in fewer complications than trabeculectomy.AIMSAssessment and comparison of the efficacy, effectiveness, safety, and resou- rce use of surgical treatment of POAG using the NPDS surgical technique with standard treatment (trabeculectomy), while outlining patients' prefe- rences regarding these POAG treatment options and impact on patients' quality of life.METHODOLOGYThe methodology pursued in the development of the report has been the GRADE methodology, following its guidelines, the prioritisation of the relative importance of the outcomes (results variables) has been carried out, in which two glaucoma ophthalmologists experts have participated. The search strategy was designed in the Pubmed databases (medline), Embase, Web of Science, CINAHL, Psycinfo, focused on the evaluation of NPDS and trabeculectomy (TE) as a treatment of POAG. Studies that met the inclu- sion criteria were selected. To provide an answer on the efficacy, effective- ness, safety and use of resources, the results of the studies related to aspects of the study design, the study population, the intervention and its compari- son, as well as the prioritised outcomes, were extracted.Since different POAG treatment strategies are identified and compa- red, a stratified analysis is performed by intervention type. 8 types of com- parisons are identified, of which evidence is available for analysis in 6 of them.RESULTSPrioritised outcomes classified as key or significant were classified accor- ding to the evaluation domain: efficacy or effectiveness, safety and use of resources. Seventeen studies were selected to perform quantitative synthe- sis to respond to these assessment domains. Classified by study design, these are 8 Randomised Clinical Trials (RCTs), 5 Non-Randomised Clinical Trials (NRCTs) and 4 observational studies.EFFICIENCY AND EFFECTIVENESSPost-intervention IOP is reduced after POAG surgery. Statistically signifi- cant differences were observed between NPDS versus TE at 12 and 24 months follow-up. The magnitude of the difference between groups in favour of TE at 12 months is 1.63 mmHg (95% CI:0.25 to 3) and 2.06 mmHg (95% CI:1.21 to 2.9) at 24 months. With implant placement during NPDS, statistically significant differences suggesting the use of TE were observed, with the magnitude of the difference being 1.42 mmHg (95% CI:0.28 to 2.56). It is not possible to determine which treatment strategy is more effec- tive with respect to full and partial success rates achieved at 12 and 24 months. The impact on visual acuity (VA) is variable depending on the strategy being compared, without being able to establish what type of treatment is related to better visual prognosis.SAFETYNPDS with implant placement is the strategy that presents the least compli- cations of hyphothalamia and choroidal detachment after surgery with res- pect to TE. The magnitude of the effect for the presence of flattened ante- rior chamber is RR=0.08 (95% CI: 0.01 to 0.60) (p=0.01) and choroidal detachment is RR=0.19 (95% CI: 0.06 to 0.59); (p=0.0004). The presence of choroidal detachment after NPDS without implant and NPDS with mitomycin C is lower than that observed with TE, since no case was described than that observed with TE. The magnitude of the effect in favour of NPDS is RR=0.08 (95% CI:0.01 to 0.62); (p=0.02) and toward NPDS with mitomycin C is RR= 0.11 (95% CI:0.01 to 0.85 (p=0.02).In this review there are few events described that are related to serious complications such as endophthalmitis, blebitis or maculopathy due to hypotonia, without observing statistically significant differences between the POAG treatment options evaluated. One eye with endophtamitis, one eye with blebitis and two with maculopathy due to hypotonia are described during follow-up.USE OF RESOURCESThe number of associated drugs after POAG surgery is reduced in all treatment strategies analyzed. It is not possible to establish the surgical treatment technique of POAG which involves administering fewer sub- conjunctival injections of 5-Fluoruracil during follow-up.PATIENT PREFERENCE AMONG POAG TREATMENT OPTIONSPatient preferences between POAG treatment options and their impact on quality of life could not be established. However, the outcomes prioritised in this report indirectly take into account and evaluate the impact and impact of surgery on the quality of life of patients.The study population included in the review is representative and valid for evaluating the results of POAG surgery globally, although in some of the comparisons between NPDS and TE identified, the study population includes some eyes treated with other types of glaucoma.There is a marked lack of evidence related mainly to NPDS with implant placement and mitomycin C during the procedure, regarding its efficacy or effectiveness and safety.It is important to note that the efficacy and safety of the implants pla- ced during the NPDS appraised in this report (Healaflow, Ologen, Esnoper V-2000, Esnoper-Clip) with respect to their efficacy and safety could not be established, as no studies were identified that evaluated them and compa- red them with standard POAG surgery.All of the foregoing means it is necessary to carry out future research with a study design with a comparison group, which encompasses an appropriate sample size that compares the NPDS with the TE and specifically these implants are re-assessed.CONCLUSIONSThe surgical treatment interventions tackling POAG analysed reduce the IOP with heterogeneous clinical results over time, without being able to clearly define the safety of one with respect to the other.
Asunto(s)
Glaucoma de Ángulo Abierto/cirugía , Cirugía Filtrante/métodos , Cirugía Filtrante/economíaRESUMEN
RESUMO O glaucoma é considerado a maior causa de cegueira irreversível no mundo, e o aumento da pressão intraocular constitui seu principal fator de risco. Usualmente, a terapia inicial do glaucoma consiste na redução da pressão intraocular a partir da instilação de drogas hipotensoras tópicas, estando as cirurgias antiglaucomatosas reservadas, na maioria das vezes, para casos em que o controle da doença não é atingido clinicamente. Classicamente, o tratamento cirúrgico do glaucoma é realizado a partir dos procedimentos filtrantes: trabeculectomia e implante de dispositivos de drenagem. O acrônimo MIGS (do inglês minimally invasive glaucoma surgery, procedimentos minimamente invasivos para glaucoma) corresponde a um grupo de procedimentos cirúrgicos pouco invasivos, que propõem a redução pressórica de maneira mais segura e previsível, quando comparada às técnicas cirúrgicas antiglaucomatosas convencionais.
ABSTRACT Glaucoma is considered the biggest cause of irreversible blindness in the world and the increase in intraocular pressure is its main risk factor. Usually, the initial therapy for glaucoma consists of reducing IOP through the instillation of topical hypotensive drugs, with antiglaucoma surgeries being normally reserved for cases in which disease control is not clinically achieved. Classically, the surgical treatment of glaucoma is performed using filtering procedures: trabeculectomy; non-penetrating sclerotomy and glaucoma drainage devices. The acronym MIGS (Minimally Invasive Glaucoma Surgery) corresponds to a group of minimally invasive surgical procedures that provide a safer and more predictable pressure reduction when compared to conventional antiglaucoma surgical techniques.
Asunto(s)
Humanos , Glaucoma/cirugía , Glaucoma de Ángulo Abierto/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Malla Trabecular/cirugía , Trabeculectomía , Stents , Cirugía Filtrante , Implantación de Prótesis , Implantes de Drenaje de Glaucoma , Inyecciones Intraoculares , Geles , Gonioscopía , Presión IntraocularRESUMEN
ABSTRACT Purpose To evaluate the cost-utility of the iStent inject® for the treatment of mild-to-moderate open-angle glaucoma (OAG) within the Brazilian Unified Health System (SUS). Methods A Markov model was developed, in which the effectiveness outcome measure was the incremental cost-effectiveness ratio (ICER: R$ / QALY quality-adjusted life-year). Direct medical costs were obtained from the SUS perspective. The base case comprised of a hypothetical cohort of patients with OAG using topical medication and being managed according to the Clinical Protocol and Therapeutic Guidelines (PCDT) and a real-world setting based on data from Datasus. The model's robustness through sensitivity analyses was tested. Results In the PCDT base case setting, the trabecular micro-bypass implant provided gains of 0.47 QALYs and an ICER of R$7,996.66/QALY compared to treatment with topical medication. In the real-world setting based on data from Datasus, the trabecular micro-bypass implant, provided gains of 0.47 QALYs and an ICER of R$4,485.68/QALY compared to treatment with topical medication. The results were robust to sensitivity analyses. Conclusion Incorporating iStent inject® to SUS provides an improvement in the patient's quality of life with an additional cost that warrants the benefit provided to patients. Results may be considered cost-effective compared to topical medication.
RESUMO Objetivo Avaliar a relação custo-utilidade do iStent inject® para o tratamento do glaucoma de ângulo aberto leve a moderado no Sistema Único de Saúde. Métodos Foi desenvolvido um modelo de Markov, no qual a medida de resultado de efetividade foi a razão custo-efetividade incremental (razão de custo-efetividade incremental: R$/ano de vida ajustado pela qualidade). Os custos médicos diretos foram obtidos por meio da perspectiva do Sistema Único de Saúde. O caso base foi composto de uma coorte hipotética de pacientes com glaucoma de ângulo aberto em uso de medicação tópica tratados de acordo com o Protocolo Clínico e Diretrizes Terapêuticas e um cenário do mundo real baseado em dados do Departamento de Informática do Sistema Único de Saúde. Foi testada a robustez do modelo por meio de análises de sensibilidade. Resultados No cenário base do Protocolo Clínico e Diretrizes Terapêuticas, o implante trabecular micro-bypass proporcionou ganhos de 0,47 ano de vida ajustado pela qualidade e razão de custo-efetividade incremental de R$7.996,66/ano de vida ajustado pela qualidade em relação ao tratamento com medicação tópica. No cenário real baseado em dados do Departamento de Informática do Sistema Único de Saúde, o implante trabecular proporcionou ganhos de 0,47 ano de vida ajustado pela qualidade e razão de custo-efetividade incremental de R$ 4.485,68/ano de vida ajustado pela qualidade em relação ao tratamento com medicação tópica. Os resultados foram robustos para análises de sensibilidade. Conclusão A incorporação do iStent inject® ao Sistema Único de Saúde proporciona melhora na qualidade de vida do paciente com um custo adicional que garante o benefício proporcionado a eles. Os resultados podem ser considerados custo-efetivos em comparação com a medicação tópica.
Asunto(s)
Humanos , Masculino , Femenino , Persona de Mediana Edad , Sistema Único de Salud , Stents/economía , Glaucoma de Ángulo Abierto/cirugía , Glaucoma de Ángulo Abierto/economía , Análisis Costo-Beneficio , Costos y Análisis de Costo , Trabeculectomía/economía , Campos Visuales/fisiología , Cadenas de Markov , Costos de la Atención en Salud , Años de Vida Ajustados por Calidad de Vida , Recursos en Salud/economía , Recursos en Salud/estadística & datos numéricos , Presión Intraocular/fisiologíaRESUMEN
ABSTRACT Minimally invasive glaucoma surgeries are surgical treatment alternatives for glaucoma aimed at reducing intraocular pressure with a better safety profile compared to traditional trabeculectomy. However, in spite of less invasive techniques, complications may develop in any surgical procedure. To the best of our knowledge, this is the first case report of anterior uveitis following combined treatment with cataract surgery and iStent inject® which addresses the management of postoperative inflammation.
RESUMO As cirurgias minimamente invasivas para glaucoma consistem em uma opção de tratamento cirúrgico para glaucoma, a qual promove redução da pressão intraocular com melhor perfil de segurança do que a trabeculectomia. Todavia, complicações são inerentes à realização de procedimentos cirúrgicos, apesar do uso de técnicas menos invasivas. Este é o primeiro relato que apresenta um caso de uveíte anterior após cirurgia combinada de catarata e iStent inject®, além de orientações quanto ao manejo do quadro inflamatório.