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1.
Clin Ophthalmol ; 18: 2593-2603, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39309685

RESUMEN

Purpose: To compare the safety and effectiveness of standalone Kahook Dual Blade (KDB) excisional goniotomy to standalone ab-interno Xen gel stent implantation in eyes with moderate-to-severe open-angle glaucoma (OAG). Methods: A single-center, retrospective study including eyes with moderate-to-severe OAG undergoing standalone KDB goniotomy or Xen gel stent implantation was conducted. Intraocular pressure (IOP), the number of antiglaucoma medications taken daily, and best-corrected visual acuity (BCVA) were recorded at baseline and for up to 36-months. Primary outcomes assessed included changes from baseline in IOP and the number of antiglaucoma medications taken. Intergroup comparisons were conducted using independent-samples Student's t-tests. The incidence of intraoperative and postoperative adverse events and the need for glaucoma surgical re-interventions were also recorded. Results: Eyes receiving standalone KDB (n=26) or Xen gel stent (n=45) surgery were analyzed. The baseline mean IOP and number of antiglaucoma medications in both groups were as follows: KDB: 23.2 ± 6.0 mmHg, 2.2 ± 1.4 medications; Xen: 22.7 ± 8.8 mmHg, 3.0 ± 1.0 medications. At 36 months, IOP was reduced to 16.6 ± 5.4 mmHg in KDB eyes (n=23, -23.5%; p=0.0004) and 15.3 ± 5.6 mmHg in Xen gel stent eyes (n=15, -22.1%; p=0.006), while number of antiglaucoma medications was reduced to 1.1 ± 0.7 (-30.8%; p=0.0005) and 2.2 ± 1.4 (-25.6%; p=0.01), respectively. Three eyes (11.5%) in the KDB group and 19 eyes (42.2%) in the Xen gel stent group required additional surgery before month 36 due to refractory high IOP. Conclusion: Both KDB goniotomy and Xen gel stent implantation significantly lowered the IOP and antiglaucoma medication burden in patients with moderate-to-severe OAG. While the Xen gel stent is frequently used to treat moderate-to-severe OAG patients with uncontrolled IOP, standalone KDB goniotomy may be equally effective as a long-term intervention, reducing the need for subsequent glaucoma surgery.

2.
Int Ophthalmol ; 44(1): 44, 2024 Feb 09.
Artículo en Inglés | MEDLINE | ID: mdl-38337081

RESUMEN

PURPOSE: To evaluate 12 month surgical outcome of Kahook Dual Blade (KDB) goniotomy in combination with cataract surgery in Latino patients with open angle glaucoma (OAG) and ocular hypertension (OHT). METHODS: This retrospective study included 45 eyes of 40 patients who underwent KDB goniotomy combined with cataract extraction from January 2016 to September 2020 at two centers in South America. Primary outcome was surgical success defined as ≥ 20% intraocular pressure (IOP) reduction or ≥ 1 medication reduction from preoperative without additional IOP-lowering procedures and an IOP ≥ 5 mmHg or ≤ 21 mmHg. Additionally, we used 2 cutoffs values for success of IOP ≤ 18 and ≤ 15 mmHg. Secondary outcomes included: IOP, medication use, best corrected visual acuity, complications and failure-associated factors. RESULTS: Success rates at 12 months with cutoff limits of 21, 18 and 15 mmHg were 84.3%, 75.6% and 58.7%, respectively. At 12 months, mean preoperative IOP significantly decreased from 19.23 ± 0.65 mmHg on 2.3 ± 1.0 medications to 14.33 ± 0.66 mmHg on 0.6 ± 0.9 medications (p < 0.001) , with 62% of eyes free of hypotensive medication. Eyes that developed postoperative IOP spikes showed a higher risk for failure using the cutoff limit of IOP ≤ 18 mmHg with a hazard ratio of 3.6 (95% confidence interval [CI], 1.80-7.13; p < 0.001). There were no serious ocular adverse events. CONCLUSIONS: KDB combined with cataract extraction showed safety and efficacy for decreasing IOP in OAG and OHT Latino patients. Additionally, dependence on medications was reduced significantly after surgery.


Asunto(s)
Extracción de Catarata , Catarata , Glaucoma de Ángulo Abierto , Glaucoma , Hipertensión Ocular , Trabeculectomía , Humanos , Trabeculectomía/métodos , Presión Intraocular , Estudios Retrospectivos , Tonometría Ocular , Resultado del Tratamiento , Extracción de Catarata/métodos , Glaucoma/cirugía , Malla Trabecular/cirugía , Hipertensión Ocular/cirugía , Hipertensión Ocular/etiología , Catarata/complicaciones
3.
International Eye Science ; (12): 965-969, 2024.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-1030829

RESUMEN

AIM: To investigate the clinical efficacy and safety of XEN drainage tube implantation combined with mitomycin C(MMC)for open angle glaucoma(OAG).METHODS:A total of 37 OAG patients(37 eyes)were retrospectively included, grouped by anti-glaucoma surgical treatment as the first choice or not, with 17 patients(17 eyes)in the group with primary surgical treatment, and 20 patients(20 eyes)in the group with the numerous surgeries. The intraocular pressure(IOP), kinds of IOP-lowering drugs, and complications were collected and analyzed in 1 a follow-up postoperatively.RESULTS:Upon the one-year follow-up, IOP had decreased from 27.56±9.94, 28.43±14.18 mmHg to 15.16±3.65, 17.18±5.83 mmHg in both groups, respectively, representing a reduction of 55.01% and 60.43%, respectively(t=4.863, P&#x003C;0.001; t=3.255, P=0.004). The IOP at various follow up points were lower than preoperative points in both groups(Ftime=6.876, Ptime&#x003C;0.001; Fintergroup=0.242, Pintergroup=0.626; Ftime×intergroup=0.959, Ptime×intergroup=0.458). The complete success rate was 47% and 45%, the qualified success rate was 76% and 75%(Z=-0.115, P=0.909), respectively, and there was no significant difference in the cumulative survival rate between two groups(χ2=0.042, P=0.838; χ2=0.004, P=0.949). At the last follow up, IOP-lowering drugs were reduced from 3(2, 3)to 1(0, 2)in both groups(Z=-3.289, -3.796, all P&#x003C;0.001), and no significant difference between groups(Z=-0.581, P=0.561). Hypotony is the most common short-term complications, anterior chamber haemorrhage followed, while, filtering bleb encapsulation is the most frequent long-term complication, no serious complications occurred, but with XEN drainage tube exposure in 1 eye and drop in 1 eye.CONCLUSION:Initial XEN drainage tube implantation combined with MMC and numerous glaucoma surgeries are both safe and effective treatment for OAG patients, while the incidence of filtering bleb encapsulation is high in those with numerous glaucoma surgeries.

4.
Ophthalmic Res ; 66(1): 1362-1375, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37972571

RESUMEN

INTRODUCTION: The aim of this study was to describe and evaluate double PreserFlo MicroShunt implantation as a modified micro-invasive glaucoma surgery technique and to retrospectively compare the outcomes in a cohort of glaucoma patients with single or double implantation. MATERIALS AND METHODS: A retrospective data analysis of 57 glaucoma patients who consecutively underwent PreserFlo implantation was performed. Medical records were examined for patients' demographics, glaucoma type, intraocular pressure (IOP), medication, complications, and re-interventions. Two groups with single (n = 29) or double (n = 28) implantation were formed, and the outcomes were compared. In cases of two-stage double implantation (n = 17), the courses of the initial and the second implantations were compared. RESULTS: Mean preoperative IOP was significantly higher in the double compared to the single implantation group (29.4 ± 10.0 mm Hg; 21.7 ± 8.2 mm Hg; p = 0.003). Postoperatively, IOP was significantly lower in the double implantation group at various time-points (day 1, week 1, months 3 and 6; all p < 0.021). In the subgroup with two-stage procedures, mean preoperative IOP was 24.5 ± 8.5 mm Hg and 29.8 ± 10.1 mm Hg, respectively (p = 0.128). While immediately postoperatively, mean IOP lowering was clinically significant and similar following both procedures, the longer sustainable effect was observed after the second procedure (month 12: 25.5 ± 7.5 mm Hg; 12.4 ± 4.8 mm Hg; p = 0.001). No serious complications were observed. DISCUSSION/CONCLUSION: Double PreserFlo implantation appears safe and efficient for lowering IOP in glaucoma patients. Our preliminary findings suggest that double is superior to single implantation in terms of IOP lowering and the need for additional topical medication. Patients with insufficient IOP lowering following single implantation may benefit from a second implantation. Further research is warranted to evaluate double implantation as a first-line, one-stage procedure.


Asunto(s)
Implantes de Drenaje de Glaucoma , Glaucoma de Ángulo Abierto , Glaucoma , Humanos , Estudios Retrospectivos , Glaucoma de Ángulo Abierto/cirugía , Glaucoma/cirugía , Presión Intraocular , Tonometría Ocular , Resultado del Tratamiento
5.
Clin Ophthalmol ; 17: 2929-2938, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37814637

RESUMEN

Purpose: To offer clinical guidance and address safety and efficacy concerns regarding the growing use of micro-invasive glaucoma surgery (MIGS) as an initial treatment for glaucoma in adult patients. Design: Narrative literature review. Methods: A review was conducted to assess outcomes and complications of MIGS in the treatment of glaucoma, both alone and in combination with lens replacement. These outcomes were compared with those of standard glaucoma surgery and/or glaucoma management with medication. Results: MIGS are effective at lowering intraocular pressure (IOP) over long periods of follow-up. These techniques share a similarly high safety profile between one another. MIGS were found to have lower complication rates and to be more effective in reducing the total amount of medication needed to maintain control of intraocular pressure than standard surgery approaches. Conclusion: MIGS techniques are growing in popularity and have been demonstrated to be a safe and effective alternative to standard glaucoma surgery. Guidance in the implementation of these procedures has been outlined.

6.
BMC Ophthalmol ; 23(1): 418, 2023 Oct 19.
Artículo en Inglés | MEDLINE | ID: mdl-37858210

RESUMEN

BACKGROUND: Xen Gel Stent implant is a new minimally invasive surgical treatment for glaucoma that has been proven effectiveness and safety profile. However, it may also lead to some complications. Xen Gel Stent occlusion is a relatively rare complication reported less frequently and has limited treatment experience. In our case report, we proposed a novel surgical treatment using a 10 - 0 nylon suture to successfully recanalize the occluded Xen45 Gel Stent. CASE PRESENTATION: A 16-year-old female patient had bilateral juvenile glaucoma for the past 5 years. Her right eye had undergone three glaucoma surgeries but failed. At a presentation to our hospital, the right eye's intraocular pressure (IOP) was 30 mmHg despite applying four different active principles. Xen45 Gel Stent implant was chosen for treatment, but six days after implantation, the IOP rose to 40 mmHg as a result of an anterior chamber tip occlusion of the Xen45 Gel Stent. Nd: YAG laser shockwave therapy was attempted but failed. The patient eventually had to return to the operating room for a revision procedure. The Xen45 Gel Stent was recanalized from the ab externo by making an L-shaped conjunctival incision at the fornix base and threading a 10 - 0 nylon suture through it. The IOP was successfully controlled in the 11-month follow-up without medication. CONCLUSION: If postoperative occlusion arises after Xen45 Gel Stent implantation, surgery using 10 - 0 nylon suture to recanalize Xen45 Gel Stent should be considered as a relatively safe, effective that does not require removal of Xen45 Gel Stent.


Asunto(s)
Implantes de Drenaje de Glaucoma , Glaucoma , Humanos , Femenino , Adolescente , Nylons , Resultado del Tratamiento , Glaucoma/cirugía , Presión Intraocular , Stents , Suturas
7.
Ophthalmol Ther ; 12(6): 2823-2839, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37855977

RESUMEN

Topical glaucoma medications are effective and safe, but they have numerous well-documented limitations that diminish their long-term utility and sustainability. These limitations can include high rates of nonadherence (with associated glaucoma progression), concerning side effects, inconsistent circadian intraocular pressure (IOP) control, complex dosing regimens, difficulty with self-administration, costs, and decreased quality of life. Despite these limitations, topical medications traditionally have been first-line in the glaucoma treatment algorithm, as no other minimally invasive treatment alternatives existed. In recent years, however, novel interventional therapies-including sustained-release drug-delivery platforms, selective laser trabeculoplasty, and micro-invasive glaucoma surgery procedures-have made it possible to intervene earlier without relying on topical medications. As a result, the topical medication-first treatment approach is being reevaluated in an overall shift toward earlier more proactive interventions.

8.
Expert Rev Ophthalmol ; 18(2): 101-111, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37520660

RESUMEN

Introduction: Non-adherence to glaucoma medication and poor follow-up is a global health concern. Areas covered: Glaucoma remains one of the largest causes of irreversible blindness worldwide. Traditional treatment guidelines suggest topical eye drop medication as first line therapy followed by addition of supplementary medications before proceeding to more invasive glaucoma surgeries. Unfortunately, poor glaucoma self-management remains high, leading to disease progression and blindness. Recent advancements in the field of pharmacotherapies, surgeries, and behavioral approaches have taken aim at increasing support for glaucoma self-management. We review the current and emerging approaches towards glaucoma management, with the exception of bleb-based surgical approaches, to investigate if they have had an impact on adherence. Literature searches were conducted via MEDLINE (PubMed), Embase (Elsevier), Cochrane Library (Wiley), and Preprints from January 1st, 2018, to January 26th, 2023. Expert opinion: The ability to offer patients a multitude of choices enables patients to tailor their glaucoma treatment to their values and lifestyle. Offering personalized patient education and coaching to support chronic glaucoma self-management would better enable patient engagement in whichever treatment path is chosen. Currently, literature regarding the impact of these new advancements on treatment engagement is lacking; this field is ripe for additional intervention and assessment.

9.
Eye Vis (Lond) ; 10(1): 10, 2023 Mar 02.
Artículo en Inglés | MEDLINE | ID: mdl-36859515

RESUMEN

BACKGROUND: Although traditional surgical procedures for glaucoma (such as trabeculectomy and tube-shunt implantation) can significantly reduce intraocular pressure (IOP), they are associated with numerous complications, some of which are vision-threatening, or involve prolonged recovery or a highly intensive postoperative course. Micro-invasive glaucoma surgery (MIGS) procedures have shown better safety but reduced efficacy in achieving target IOP. Combinations of these methods have led to the development of subconjunctival micro-invasive procedures with safety comparable to traditional surgery and greater efficacy than minimally invasive methods. This review describes the use of one of these devices, the poly(styrene-block-isobutylene-block-styrene) (SIBS)-based PreserFlo MicroShunt (Santen, Emeryville, CA), in the surgical treatment of patients with glaucoma. MAIN TEXT: The MicroShunt is an 8.5-mm tube made of an inert polymer with no endplate, an internal diameter of 70 µm, and fins intended to prevent peritubular flow and anchor the device within the sclera to prevent proximal migration into the eye. Following ab externo implantation, the tube provides a conduit for flow of aqueous humor from the anterior chamber into the subconjunctival/sub-Tenon space. Clinical trials to date have shown that, when paired with mitomycin C (MMC) treatment, MicroShunt implantation significantly reduced both IOP and the number of glaucoma medications. These IOP-lowering results were found both when surgery was performed alone and with phacoemulsification. The MicroShunt also showed a safety profile comparable to that of traditional filtering surgery. CONCLUSIONS: The MicroShunt and other novel subconjunctival procedures have shown substantial IOP reductions while mitigating hypotony-related complications. MMC, which modulates fibrosis and scarring postoperatively, is essential to surgical success. Randomized, long-term clinical trials will further clarify the role of controlled micro-incisional device-assisted ab externo glaucoma filtering surgery in long-term glaucoma management.

10.
J Fr Ophtalmol ; 46(3): 266-275, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36801112

RESUMEN

PURPOSE: To report the relative efficacy of combining phacoemulsification with a Schlemm's canal microstent (Phaco/Hydrus) or dual blade trabecular excision (Phaco/KDB). DESIGN: Retrospective study. METHODS: One hundred and thirty-one eyes of 131 patients who underwent Phaco/Hydrus or Phaco/KDB procedures from January 2016 to July 2021 at a tertiary care center were included and assessed for up to 36months postoperatively. Primary outcomes were intraocular pressure (IOP) and number of glaucoma medications, evaluated by generalized estimating equations (GEE). Two Kaplan-Meier estimates (KM) assessed survival without additional intervention or pressure lowering medication while maintaining: (1) IOP≤21mmHg and≥20% IOP reduction or (2) IOP≤preoperatively designated goal. RESULTS: Mean preoperative IOP was 17.70±4.91 (SD) mmHg on 0.28±0.86 medications in the Phaco/Hydrus cohort (n=69) and 15.92±4.34mmHg on 0.19±0.70 medications in the Phaco/KDB cohort (n=62). At 12months, mean IOP was reduced to 14.98±2.77mmHg on 0.12±0.60 medications after Phaco/Hydrus and 13.52±4.13mmHg on 0.04±0.19 medications after Phaco/KDB. GEE models of IOP (P<0.001) and medication burden (P<0.05) showed significant patterns of reduction across all timepoints in both cohorts. There were no differences in IOP reduction (P=0.94), number of medications (P=0.95) or survival (P=0.72 by KM1, P=0.11 by KM2) between procedures. CONCLUSIONS: Both Phaco/Hydrus and Phaco/KDB resulted in significantly reduced IOP and medication burden for over 12months. Phaco/Hydrus and Phaco/KDB confer similar outcomes in terms of IOP, medication burden, survival, and procedural time in a population with predominantly mild and moderate open-angle glaucoma.


Asunto(s)
Glaucoma de Ángulo Abierto , Glaucoma , Hipotensión Ocular , Facoemulsificación , Trabeculectomía , Humanos , Facoemulsificación/efectos adversos , Facoemulsificación/métodos , Glaucoma de Ángulo Abierto/complicaciones , Glaucoma de Ángulo Abierto/cirugía , Estudios Retrospectivos , Canal de Schlemm , Trabeculectomía/métodos , Glaucoma/complicaciones , Glaucoma/cirugía , Presión Intraocular , Hipotensión Ocular/cirugía
11.
Adv Ther ; 39(9): 4076-4093, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35790641

RESUMEN

INTRODUCTION: We report 2-year outcomes after implantation of iStent trabecular micro-bypass stent with phacoemulsification, in Japanese patients with mild-moderate open-angle glaucoma (OAG). METHODS: This was a 24-month, prospective, longitudinal, observational, post-marketing study conducted between July 2017 and September 2020. Patients consisted of adults with OAG on antiglaucoma medications who had cataract surgery combined with one iStent implantation. Outcome measures included intraocular pressure (IOP), antiglaucoma medications, treatment success rates (defined as eyes having lower IOP with same or reduced number of medications from baseline, or same IOP with reduced number of medications from baseline, and not requiring secondary glaucoma surgeries postoperatively), and safety. Outcomes were analyzed in the overall cohort and in glaucoma subtypes: primary OAG, normal-tension glaucoma, and exfoliative glaucoma. RESULTS: Overall, 232 eyes were enrolled. At 24 months, mean ± standard deviation IOP decreased from 17.6 ± 4.0 mmHg preoperatively to 14.3 ± 3.0 mmHg (p < 0.05), and mean number of medications reduced from 2.2 ± 1.2 preoperatively to 0.7 ± 1.2 (p < 0.05). Similar trends were observed across glaucoma subtypes. In the overall cohort, 96.7%, 95.3%, and 93.7% of patients achieved treatment success at 6, 12, and 24 months, respectively. There were 67.6% medication-free eyes at 24 months compared to 3.2% medication-free eyes preoperatively (p < 0.0001). Safety profile was favorable over the 2-year period. CONCLUSIONS: Following iStent implantation with phacoemulsification, clinically relevant and statistically significant reductions in IOP and number of medications were observed in Japanese eyes with OAG over 2 years, with favorable safety profile. These reductions were observed across all glaucoma subtypes.


Asunto(s)
Glaucoma de Ángulo Abierto , Glaucoma , Facoemulsificación , Adulto , Glaucoma/cirugía , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Glaucoma de Ángulo Abierto/cirugía , Humanos , Presión Intraocular , Japón , Mercadotecnía , Vigilancia de Productos Comercializados , Estudios Prospectivos , Stents , Malla Trabecular/cirugía
12.
J Clin Med ; 11(12)2022 Jun 17.
Artículo en Inglés | MEDLINE | ID: mdl-35743562

RESUMEN

Primary open-angle glaucoma (POAG) is currently treated with a variety of surgical and non-surgical approaches. Minimally invasive glaucoma surgery (MIGS) involves several devices and procedures that lower intraocular pressure (IOP) by increasing aqueous outflow. The first laser-based MIGS procedure, Excimer Laser Trabeculostomy (ELT), has emerged as a safe and effective treatment option. This article reviews ELT within the context of alternative MIGS procedures and focuses on the historical development of ELT, principles and techniques of the ELT procedure, safety and efficacy data, comparison to other outflow procedures, and future augmentations to expand the use of ELT. Performed alone or as an adjunct to cataract surgery, ELT has minimal complications and has shown long-term effectiveness in lowering intraocular pressure in thousands of patients. The non-thermal laser-tissue interactions of excimer lasers minimize peripheral tissue damage and ensure outflow channel patency without requiring foreign body implants or creating blebs. The development of 2D optical and 3D optical coherence tomography (OCT) guidance systems will eliminate the need for a goniolens to visualize angle structures and enable thousands more surgeons to perform ELT in the future.

13.
Diagnostics (Basel) ; 12(5)2022 May 17.
Artículo en Inglés | MEDLINE | ID: mdl-35626405

RESUMEN

Background: The purpose of this study is to compare the morphology of six-month follow-up blebs created by a subconjunctival glaucoma surgical device (XEN45) to those created by a PreserFlo MicroShunt with a sub-Tenon insertion, utilizing AS-OCT. Methods: A retrospective study of 29 eyes who underwent XEN45 implantation and 29 eyes who underwent PreserFlo MicroShunt implantation. The patients were analyzed at 24 h, 1 week, 1 month, 3 months and 6 months. At each visit, the maturation and morphological alterations of the blebs were observed, as well as connections with the IOP. Results: In both groups, IOP showed significant reduction at all follow ups (p < 0.0001). In XEN group, the most common bleb morphology in the immediate postoperative was the subconjuntival separation type (42%) followed by the uniform type (34%), with a trend inversion at 6 month follow up (51% of uniform type). On the contrary, the most common morphology after PreserFlo was the multiple internal layer (55%), which showed a tendency to reduce over time and was substituted by the microcystic multiform, whose percentage increased over time (17% at day 1 vs. 44% at month 6). Uniform appearance was associated by the posterior episcleral fluid (PEF) lake presence. Both horizontal and vertical diameters significantly increased over time. Conclusion: XEN and PreserFlo implantation resulted in the production of diffuse blebs with different characteristics, which may influence IOP lowering capacity and bleb revisions necessity over time.

14.
Am J Ophthalmol Case Rep ; 26: 101410, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35243153

RESUMEN

PURPOSE: Anterior segment optical coherence tomography (AS-OCT) is an emerging imaging modality with an expanding role in glaucoma diagnosis and management. We present a series of two cases of iatrogenic cyclodialysis cleft and their conservative management being directly informed by non-invasive AS-OCT monitoring. OBSERVATIONS: Retrospective case series. A 51 year-old male and a 29 year-old male each underwent gonioscopy-assisted transluminal trabeculotomy for uncontrolled glaucoma with a cyclodialysis cleft being diagnosed postoperatively and then monitored using serial AS-OCT images. In both cases, conservative medical management was initially employed. Worsening hypotony maculopathy and decreasing best corrected visual acuity were evident in both cases at times when gonioscopy yielded inadequate visualization to meaningfully inform treatment decisions. Escalation to more invasive therapies was therefore considered. AS-OCT imaging revealed consistent anatomical improvement at each follow-up and ultimately both clefts closed without treatment escalation. CONCLUSIONS AND IMPORTANCE: AS-OCT played a critical role in the diagnosis and directly informed the conservative management of both of these cases. This non-invasive imaging modality may allow for deferral of invasive treatment escalation in some cases of cyclodialysis cleft.

15.
Vision (Basel) ; 6(1)2022 Feb 09.
Artículo en Inglés | MEDLINE | ID: mdl-35225971

RESUMEN

For moderate-to-severe glaucoma, trabeculectomy remains the "gold standard" intraocular pressure (IOP)-lowering treatment; nonetheless, this method requires extensive post-operative maintenance. Microinvasive glaucoma surgery (MIGS) treatments are designed to lessen intra- and post-operative care burden while offering an acceptable IOP decrease for individuals with mild to moderate glaucoma. The PreserFlo® MicroShunt (previously InnFocus MicroShunt) is an 8.5 mm glaucoma drainage device manufactured from poly(styrene-block-isobutylene-block-styrene) (SIBS), an extremely biocompatible and bioinert material. The lumen is narrow enough to prevent hypotony, but big enough to avoid being obstructed by sloughed cells or pigment. The device is implanted ab externo, as a stand-alone procedure or in conjunction with cataract surgery, with intraoperative mitomycin C, and a bleb is produced under the conjunctiva and Tenon's capsule. The MicroShunt was CE-marked in 2012 and designed for primary open-angle glaucoma, the IOP of which remains uncontrolled after maximally tolerated topical treatment. Several clinical trials evaluating the MicroShunt's long-term safety and effectiveness have been conducted, highlighting the effectiveness of the device over time, along with a tolerable safety profile. The present review aims to gather evidence of PreserFlo's effectiveness and safety results almost 10 years after its introduction, and furthermore, to compare it with other MIGS and with the gold-standard trabeculectomy for glaucoma management.

16.
Ophthalmol Ther ; 11(1): 271-292, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-34825352

RESUMEN

INTRODUCTION: This retrospective consecutive study compared standalone implantation of multiple (2-3) trabecular micro-bypass stents (iStent inject ± iStent) (Multi-Stent group) vs trabeculectomy + mitomycin C (Trab group) in moderate to severe open-angle glaucoma (OAG). METHODS: Eligible patients underwent Multi-Stent or Trab surgery from 2018 to 2020 and had at least 3-month follow-up; visual field mean deviation (VF MD) - 6 dB or worse; inadequate prior response to maximum medications ± laser procedures; and had trabeculectomy as their next planned intervention. Primary effectiveness, safety-adjusted treatment success, was defined as ≥ 20% intraocular pressure (IOP) reduction on the same or fewer medications, without clinically significant safety events (severe complications, secondary surgeries, reinterventions). Secondary effectiveness included mean IOP and medications; qualified and complete attainment of target IOP (≤ 21/18/15/12 mmHg and > 6 mmHg); health-economic and quality-of-life (QoL) measures; and 2-vs-3-stent subgroup analysis. RESULTS: The baseline groups (n = 70 Multi-Stent/40 Trab) were similar: mean IOP (21.1 mmHg/22.3 mmHg); medications (2.87/3.10 medications); disease stage (30%/35% severe); VF MD (- 10.1 dB/- 10.4 dB); and mean last follow-up (LFU, 13.1 months/15.7 months) (all differences non-significant). Primary effectiveness: treatment success at LFU was 62.9% vs 30.0% in Multi-Stent vs Trab eyes, respectively (p = 0.001). Secondary effectiveness: At LFU in Multi-Stent vs Trab groups, respectively: mean IOP decreased by 31% to 14.2 mmHg (p < 0.001) vs by 43% to 12.5 mmHg (p < 0.001); mean medications decreased by 51% to 1.31 medications (p < 0.001) vs by 84% to 0.43 medications (p < 0.001). Multi-Stent eyes, compared to Trab eyes, had fewer visits ± reinterventions within 3 months (3.6 vs 6.1, p < 0.001); longer time to first reintervention (12.2 months vs 4.5 months, p = 0.01); fewer total reinterventions (0.26 vs 0.75, p = 0.006); and earlier lifting of postoperative restrictions (12.6 vs 32.1 days, p < 0.001). In 2-vs-3-stent analysis, there was a trend toward more 3-stent eyes achieving target IOP than 2-stent eyes. Visual fields remained stable in both Multi-Stent and Trab eyes. CONCLUSION: Implanting 2-3 trabecular micro-bypass stents was a viable alternative to trabeculectomy for moderate-to-severe OAG, with clinically appropriate IOP/medication reductions and higher safety-adjusted treatment success vs trabeculectomy.

17.
Eye Vis (Lond) ; 8(1): 33, 2021 Sep 03.
Artículo en Inglés | MEDLINE | ID: mdl-34479641

RESUMEN

PURPOSE: To report preliminary 6-month results on the use of the Preserflo Microshunt implant with and without Ologen in 50 pseudophakic eyes with moderate to advanced primary open-angle glaucoma (POAG). METHODS: Fifty pseudophakic eyes underwent ab externo Preserflo Microshunt implantation. Data was gathered retrospectively and two groups were then created, group A with application of MMC 0.2 mg/ml and group B with MMC 0.2 mg/ml and Ologen collagen matrix (OCM) implantation. Absolute success was regarded as the percentage of eyes achieving: a) 5 ≤ intraocular pressure (IOP) ≤ 13 mmHg, b) 5 ≤ IOP ≤ 16 mmHg, and c) 5 ≤ IOP ≤ 21 mmHg without additional medication or surgery and qualified success was regarded as the percentage of eyes achieving a) IOP ≤ 13 mmHg, b) IOP ≤ 16 mmHg, and c) IOP ≤ 21 mmHg with or without medication. Evaluation was performed using a log-rank Kaplan-Meier test. A scatterplot analysis presented the treatment effect data of all eyes with a minimum of 20% IOP reduction per case. Failure was defined as requiring additional surgery, IOP greater than 21 mmHg with or without medication and failure to reach 20% IOP reduction. RESULTS: Mean postoperative IOP was significantly lower in both groups. IOP decreased by 49.06% in group A and by 53.01% in group B at 6 months (P < 0.88), respectively. Medication use was lower in both groups (Wilcoxon test, P < 0.001). The absolute and qualified success rates were not statistically significant between the groups (all P > 0.05). Cumulative IOP results per case were not statistically different in group A compared with group B. One revision surgery in group A (4% failure rate) and three in group B (12% failure rate) were performed. CONCLUSIONS: Both groups showed equal results in terms of cumulative and mean IOP reduction, medication reduction as well as in absolute and qualified success rates. No significant difference was found in any parameters tested between Preserflo Microshunt with MMC 0.2 mg/ml and with or without OCM implantation at 6 months. Long-term follow-up is required to further evaluate this data.

18.
Semin Ophthalmol ; 36(8): 772-786, 2021 Nov 17.
Artículo en Inglés | MEDLINE | ID: mdl-34297650

RESUMEN

PURPOSE: Interest in micro-invasive glaucoma surgery (MIGS) has exploded over the last 8 years with an increase in MIGS procedures of at least 400% in the United States, according to Medicare data. MIGS is an umbrella term that can cover many different types of surgeries. This review focuses on peer-reviewed evidence for Trabectome®, iStent inject®, Kahook Dual Blade®, XEN® Gel Stent, and Hydrus®. METHODS: We present key recent studies evaluating the efficacy and safety of MIGS in various types of glaucoma patients with different stages of disease. CONCLUSION: We conclude that MIGS is generally safe and efficacious, although only some MIGS have been studied through randomized clinical trials. When comparing and contrasting the different MIGS procedures, large prospective studies are not yet the norm. High-quality large prospective studies involving MIGS will be an important next step as ophthalmologists decide how to incorporate MIGS into their surgical armamentarium.


Asunto(s)
Glaucoma , Presión Intraocular , Anciano , Glaucoma/cirugía , Humanos , Medicare , Procedimientos Quirúrgicos Mínimamente Invasivos , Estudios Prospectivos , Estados Unidos
19.
Adv Clin Exp Med ; 30(1): 49-54, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33529507

RESUMEN

BACKGROUND: Micro-invasive glaucoma surgery (MIGS) and MIGS devices have been gaining increasing attention in recent years. One such device is the trabecular micro-bypass stent, or iStent® (Glaukos Corporation, Laguna Hills, USA). OBJECTIVES: To evaluate the safety and efficacy of the minimally invasive ab interno surgical implantation of a trabecular bypass during cataract surgery in reducing intraocular pressure (IOP) in patients with mild and moderate open-angle glaucoma and cataracts. MATERIAL AND METHODS: The study was a prospective, uncontrolled, interventional case series (a prospective study of a case series), including 54 patients with a mean age of 72 years. All subjects underwent ab interno implantation of a single iStent together with cataract surgery. The corrected distance visual acuity (CDVA), IOP, anti-glaucoma medications, visual field, and number and type of complications were investigated after surgery. The patients were followed up at 1, 7, and 30 days, and 3, 6, 12, 24 and 36 months after the operation. RESULTS: The mean observation time was 20 months. At baseline, CDVA was 0.5 or better in 65% of the eyes; this improved to 0.5 or better in all eyes (0.8 or better in 79%) at the end of the observation. The mean baseline IOP was 17.1 mm Hg, which fell to a mean of 15.1 mm Hg. The mean number of medicinal eye drops prescribed preoperatively was 1.7, which decreased to 0.26 at the end of the observation. CONCLUSIONS: Cataract surgery combined with iStent implantation seems to be an effective procedure in patients with mild to moderate open-angle glaucoma and cataracts. The insertion of 1 stent resulted in a significant decrease in IOP and a reduction in the number of topical anti-glaucoma medications needed. Based on the characteristics of the observed complications, iStent implantation can be considered a safe method.


Asunto(s)
Glaucoma de Ángulo Abierto , Facoemulsificación , Anciano , Glaucoma de Ángulo Abierto/cirugía , Humanos , Presión Intraocular , Estudios Prospectivos , Stents , Malla Trabecular/cirugía
20.
J Natl Med Assoc ; 113(2): 230-236, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33158570

RESUMEN

INTRODUCTION: To determine the efficacy and safety of Kahook Dual Blade (KDB) goniotomy alone or combined with phacoemulsification cataract surgery to lower intraocular pressure and medication burden in Black and Afro-Latinx patients with open angle glaucoma (OAG). MATERIALS AND METHOD: A retrospective, single center case series of patients with OAG who were managed with medications and underwent phacoemulsification combined with goniotomy (PE + KDB) using Kahook Dual Blade or goniotomy alone (KDB alone) in pseudophakic patients. Indications for glaucoma surgery included reduction of intraocular pressure (IOP) and reduction of medication burden. Our study parameters included pre- and postoperative information on IOP, the use of IOP-lowering medications, visual field, and adverse events through 6 months of follow-up. RESULTS: Among all 63 eyes of 63 patients undergoing surgery, Kahook goniotomy with or without phacoemulsification, mean IOP was significantly reduced from 17.4 mmHg at baseline to 14.0 mmHg at month 6 (P = 0.0012), a 19.5% reduction (KDB alone -26.4%, PE + KDB -16.6%). The mean number of topical IOP-lowering medications was reduced from 2.6 at baseline to 1.6 ± 0.3 at month 6 (P = 0.0012), a 38.5% reduction (Kahook alone -10.7%, PE + Kahook -48.0%). Mean visual fields were stable in the PE + KDB group and progressed in the KDB alone group. Postoperative adverse events were mild and included transient hyphema, IOP spikes, posterior capsule opacification, tearing, glare and mild pain. CONCLUSION: Phacoemulsification combined with Kahook dual blade goniotomy significantly lowers both IOP and medication burden in Black and Afro-Latinx patients with open angle glaucoma. In pseudophakic patients with advanced glaucoma medication burden is not significantly reduced and visual field progression occurred. Adverse events were not sight-threatening and self limited.


Asunto(s)
Glaucoma de Ángulo Abierto , Glaucoma , Trabeculectomía , Adulto , Glaucoma/cirugía , Glaucoma de Ángulo Abierto/cirugía , Humanos , Estudios Retrospectivos , Resultado del Tratamiento
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