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PURPOSE: To examine complications, visual outcomes, photic patient-reported symptoms, corneal morphology, IOL tilt, and intraocular pressure after implantation of an intraocular lens (IOL) and iris prosthesis (IP) following iridocyclectomy. METHODS: Patients with previous iridocyclectomy treated with an IOL and IP at the Copenhagen University Hospital Rigshospitalet between 2007 and 2018 were included in this national retrospective non-comparative case series. The assessment encompassed BCVA, PRO questionnaire, corneal topography, and anterior segment OCT. RESULTS: 45 patients were included. Eight of 45 patients were previously treated with ruthenium-106 brachytherapy in conjunction with iridocyclectomy. Six of 45 patients developed endothelial dysfunction four of whom had received ruthenium-106 brachytherapy. Five of 45 patients had subluxation of the IOL/IP complex due to incomplete zonula apparatus. BCVA improved for all patients after lens surgery. 26 patients participated in the invited follow-up examination. 19 of 26 (73%) reported none or mild photic symptoms after IP instalment. Five (19%) reported ongoing severe photic symptoms. The corneal astigmatism significantly increased after iridocyclectomy but did not change after lens surgery. CONCLUSIONS: Implantation of an IOL and IP is a safe procedure, alleviating photic symptoms in most patients. It comes with higher risk of complications due to a more demanding procedure and larger surgical traumas from previous treatments. Ruthenium-106 brachytherapy increases the complication risk. Corneal astigmatism is induced by iridocyclectomy but does not change after lens surgery.
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Iridectomía , Neoplasias del Iris , Iris , Melanoma , Agudeza Visual , Humanos , Estudios Retrospectivos , Melanoma/cirugía , Melanoma/diagnóstico , Melanoma/radioterapia , Femenino , Masculino , Neoplasias del Iris/cirugía , Neoplasias del Iris/diagnóstico , Persona de Mediana Edad , Anciano , Iridectomía/métodos , Iris/cirugía , Extracción de Catarata , Estudios de Seguimiento , Resultado del Tratamiento , Adulto , Implantación de Prótesis/métodos , Braquiterapia/efectos adversos , Braquiterapia/métodos , Anciano de 80 o más Años , Cuerpo Ciliar/cirugía , Implantación de Lentes Intraoculares/métodos , Tomografía de Coherencia ÓpticaRESUMEN
PURPOSE: There are currently limited treatment options for aniridia. In this context, 3D printed iris implants may provide a cost-effective, cosmetically acceptable alternative for patients with aniridia. The purpose of this study was to develop a proof-of-concept workflow for manufacturing 3D printed iris implants using a silicone ink palette that aesthetically matches iris shades, identified in slit lamp images. METHODS: Slit lamp iris photos from 11 healthy volunteers (3 green; 4 blue; 4 brown) were processed using k-means binning analyses to identify two or three prominent colors each. Candidate silicone inks were created by precisely combining pigments. A crowdsourcing survey software was used to determine color matches between the silicone ink swatches and three prominent iris color swatches in 2 qualifying and 11 experimental workflows. RESULTS: In total, 54 candidate silicone inks (20 brown; 16 green; 18 blue) were developed and analyzed. Survey answers from 29 individuals that had passed the qualifying workflow were invited to identify "best matches" between the prominent iris colors and the silicone inks. From this color-match data, brown, blue, and green prototype artificial irises were printed with the silicone ink that aesthetically matched the three prominent colors. The iris was printed using a simplified three-layer five-branch starburst design at scale (12.8 mm base disc, with 3.5 mm pupil). CONCLUSIONS: This proof-of-concept workflow produced color-matched silicone prosthetic irises at scale from a panel of silicone inks using prominent iris colors extracted from slit lamp images. Future work will include printing a more intricate iris crypt design and testing for biocompatibility.
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INTRODUCTION: Iris prostheses are an integral tool for the management of symptoms in the setting of damaged, insufficient, or absent irides. Fixation of a custom iris prosthesis in the absence of capsular support raises similar challenges to the fixation of an intraocular lens (IOLs) without capsular support. Centration and planar orientation of these larger iris devices are perhaps even more important than with IOLs. METHODS: We describe two variations of a reliably reproducible suture fixation technique for securing these special devices using a modification of the tiltless, centration-adjustable suture technique for sclerally-fixated posterior chamber IOLs. RESULTS: We described a few techniques that are safe and reproductible. That have been used in more than 300 cases in our co-hort with success and follow-ups of over 10 year. CONCLUSION: We go over the technique step-by-step, highlighting the critical steps and pitfalls to avoid complications and achieve satisfactory results and aiming to get more surgeons to use these techniques and help facilitate the steep learning curve some of the steps might have.
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Implantación de Lentes Intraoculares , Lentes Intraoculares , Humanos , Implantación de Lentes Intraoculares/métodos , Iris/cirugía , Esclerótica/cirugía , Suturas , Técnicas de SuturaRESUMEN
Congenital aniridia is a rare, panocular disorder with a main phenotypic characteristic of a partial or complete absence of the iris existing alongside other ocular morbidities such as cataract, keratopathy, optic nerve and foveal hypoplasia, and nystagmus. The iris abnormality, however, often leads to symptoms such as photophobia, glare, and decreased visual acuity, as well as cosmetic dissatisfaction. Current management options for the iris deficit include colored iris contact lenses, corneal tattooing, and tinted contact lenses. Symptoms arising from small iris defects can be resolved with surgical management using micro-tying suture techniques such as McCannel or Siepser. Currently, larger iris defects can be treated with artificial iris implants. New prosthetic options range from colored intraocular lenses to flexible custom-made silicone iris implants. With a range of therapeutic options available and given the challenges of multiple comorbidities in aniridia, we evaluate the literature relating to the use of artificial iris implants in congenital aniridia, with a focus on the different surgical implantation techniques, the clinical outcomes achieved, complications occurred, and risk of bias of the studies included.
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Aniridia , Lentes Intraoculares , Humanos , Agudeza Visual , Aniridia/cirugía , Aniridia/complicaciones , Iris/cirugía , Lentes Intraoculares/efectos adversos , Implantación de Prótesis/efectos adversos , Trastornos de la Visión/etiologíaRESUMEN
PURPOSE: This study is to describe the clinical outcome of penetrating keratoplasty combined with implantation of a novel intraocular lens with an artificial iris, aided by continuous vitreous chamber infusion, in patients with severe aniridia and corneal alterations. METHODS: This was a prospective single-center case series study involving five patients with corneal alterations and aniridia. All subjects underwent simultaneous penetrating keratoplasty and implantation of a new intraocular lens with an artificial iris with the assistance of infusion into the vitreous chamber to regulate intraocular pressure during the surgical procedure. Visual acuity, corneal endothelial cell density, and intraocular pressure assessments were performed in the postoperative period. The final cosmetic outcome of the iris prosthesis placement was also evaluated. RESULTS: In all cases, increased visual acuity and a good aesthetic result were observed in all affected eyes except one in which, despite the excellent aesthetic outcome, the eye was very hypotonic as it had high myopia and had undergone several previous surgeries. CONCLUSION: The single surgical procedure combining implantation of an intraocular lens-iris prosthesis with penetrating keratoplasty is an effective technique for the simultaneous treatment of aphakia and aniridia. However, larger series with longer-term follow-up are needed to definitively establish the benefits of this technique.
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Aniridia , Opacidad de la Córnea , Lentes Intraoculares , Humanos , Implantación de Lentes Intraoculares/métodos , Queratoplastia Penetrante/métodos , Estudios Prospectivos , Aniridia/complicaciones , Aniridia/diagnóstico , Aniridia/cirugía , Iris/cirugía , Opacidad de la Córnea/cirugía , Estudios RetrospectivosRESUMEN
PURPOSE: To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects. DESIGN: Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial. PARTICIPANTS: Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both. METHODS: Eyes were implanted from November 26, 2013, to December 1, 2017, with a custom, foldable artificial iris by 1 of 4 different surgical techniques. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months after surgery. At each examination, slit-lamp findings, intraocular pressure, implant position, subjective visual symptoms, and complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were measured at 3, 6, or 12 months as additional safety evaluations. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale was used to assess cosmetic results. MAIN OUTCOME MEASURES: Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, Global Aesthetic Improvement Scale rating, prosthesis-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months after surgery. RESULTS: At the 12-month postoperative examination, a 59.7% reduction in marked to severe daytime light sensitivity (P < 0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (P < 0.0001), a 53.1% reduction in marked to severe daytime glare (P < 0.0001), and a 48.5% reduction in severe nighttime glare (P < 0.0001) were found. A 15.4-point improvement (P < 0.0001) in the NEI VFQ-25 total score was found, and 93.8% of patients reported an improvement in cosmesis as measured by the Global Aesthetic Improvement Scale 12 months after surgery. No loss of CDVA of > 2 lines related to the device was found. Median ECD loss was 5.3% at 6 months after surgery and 7.2% at 12 months after surgery. CONCLUSIONS: The artificial iris surpassed all key safety end points for adverse events related to the device, IOL, or implant surgery and met all key efficacy end points, including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.
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Iris , Implantación de Lentes Intraoculares , Humanos , Iris/anomalías , Iris/cirugía , Implantación de Lentes Intraoculares/métodos , Lentes Intraoculares , Fotofobia/cirugía , Estudios Prospectivos , Calidad de Vida , Estados Unidos , United States Food and Drug AdministrationRESUMEN
BACKGROUND: Three groups of iris prostheses can be distinguished for the surgical treatment of iris defects: (1) segmental iris implants, (2) combined iris diaphragm intraocular lenses (IOL) and (3) pure iris implants. Most iris reconstructions are accompanied by aphakia correction with secondary IOL implantation. Although the primary goal is to create a pupil and to improve glare perception, contrast sensitivity and visual acuity, the esthetic result is also a relevant component. OBJECTIVE: Functional and esthetic results after replacement of an aniridia IOL implant with a custom-made artificial iris with IOL. MATERIAL AND METHODS: In this retrospective study with seven eyes from seven patients, an iris diaphragm IOL (Morcher GmbH, Stuttgart, Germany) was exchanged for medical reasons (subluxation) against a custom-made artificial iris made of silicone (ArtificialIris, HumanOptics, Erlangen, Germany) in combination with a sutured IOL. The follow-up period was at least 3 months. Best corrected distance visual acuity (BCVA), endothelial cell count (ECC), complications, glare perception as well as esthetic outcome and patient satisfaction were evaluated. RESULTS: The BCVA and ECC showed no statistically significant change between the preoperative and postoperative values (pâ¯> 0.05). There was a decentration of the iris IOL implant of 0.27⯱ 0.19â¯mm three months postoperatively. On a visual analogue scale (VAS) from 1 to 10 (1â¯= not satisfied at all, 10â¯= extremely satisfied), satisfaction with the overall result was rated 8.6⯱ 2.5. Subjective glare perception improved to 5.6⯱ 3.5 and subjective esthetic impairment improved to 2.4⯱ 2.0 on the VAS (1â¯= none, 10â¯= extremely strong). Postoperative complications included transient intraocular hypotonia in two eyes, intraocular pressure increase in two eyes, retinal detachment and transient vitreous hemorrhage in one eye each. Of the seven patients six would repeat the procedure. CONCLUSION: Compared to a rigid aniridia IOL implant, replacement with a custom-made artificial iris in combination with an IOL provides not only a good functional result but simultaneously also an esthetically pleasing result.
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Aniridia , Lentes Intraoculares , Aniridia/cirugía , Humanos , Iris/cirugía , Implantación de Lentes Intraoculares , Estudios RetrospectivosRESUMEN
PURPOSE: The aim of this study is to analyze the outcome of various techniques for a custom-made iris prosthesis implantation as part of reconstructive anterior segment surgery following traumatic aniridia. METHODS: This retrospective interventional study was done for 6 eyes that received an artificial iris as secondary reconstructive measure for photophobia and unsatisfactory vision following initial globe repair. Different implantation techniques were employed. These included simple sulcus implantation, implantation of a composite (iris prosthesis with attached intraocular lens) implant, and combinations with phacoemulsification, vitrectomy, and penetrating keratoplasty. RESULTS: In all cases, the artificial iris was implanted successfully. In the follow-up period (1-48 months), postoperative complications included rhegmatogenous retinal detachment, prolonged intraocular inflammation, and corneal transplant decompensation due to graft rejection. There was no case of secondary glaucoma. Complications could be managed successfully. All patients showed improved best-corrected visual acuity and were satisfied with functional and cosmetic results. CONCLUSION: This case series highlights the different implantation techniques for reconstruction of the anterior segment after ocular trauma. The versatility of the custom-made iris implant accounts for a wide range of applications and the foldable material reduces the need for large incisions in the already traumatized eye.
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Aniridia , Lesiones Oculares , Lentes Intraoculares , Aniridia/cirugía , Lesiones Oculares/complicaciones , Lesiones Oculares/diagnóstico , Lesiones Oculares/cirugía , Humanos , Iris/cirugía , Implantación de Lentes Intraoculares , Estudios Retrospectivos , Agudeza VisualRESUMEN
Aim: To describe our results with HumanOptics IOL-ArtificialIris complex in post traumatic aphakia and aniridia. Methods: Retrospective, single-surgeon chart review of cases in which aniridia and aphakia were corrected using HumanOptics IOL-ArtificialIris complex sutured to the sclera with Gore-Tex® sutures and coupled with the Akreos® IOL (Bausch&Lomb). Results: The authors present four cases of ocular trauma with globe rupture. For every patient, posterior vitrectomy was done and an artificial iris-lens diaphragm was sutured to the sclera. All patients had a good functional and cosmetic outcome. Conclusions: Surgical implantation of the HumanOptics IOL-ArtificialIris complex coupled with the Akreos® IOL was successful in alleviating post-trauma aphakia and aniridia related visual impairment.
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BACKGROUND: Post-operative endophthalmitis is a serious complication of intraocular surgery which may present acutely or chronically. Chronic post-operative endophthalmitis is characterized by decreased visual acuity, mild pain, and low-grade uveitis several weeks or months after intraocular surgery which may be responsive to corticosteroids, but recur upon tapering. Low virulence organisms such as Propionibacterium acnes are the most common culprit organisms, and treatment most often consists of both intravitreal antibiotic injections and surgery. Aniridia is a condition defined by total or partial loss of the iris and leads to decreased visual quality marked by glare and photophobia. Treatment of complex or severe cases of traumatic aniridia in which surgical repair is difficult may consist of implantation of iris prostheses, devices designed to reduce symptoms of aniridia. Though chronic, post-operative endophthalmitis has been associated with most intraocular surgeries including intraocular lens implantation after cataract removal, it has never been described in a patient with an iris prosthesis. CASE PRESENTATION: In this case report, we describe the case of a 49 year old, male construction worker with traumatic aniridia who experienced chronic, recurrent low-grade intraocular inflammation and irritation for months after implantation of the Ophtec 311 prosthetic iris. Symptoms and signs of inflammation improved temporarily with sub-Tenon's capsule triamcinolone injections. Ultimately after more than 2 post-operative years, the iris prosthesis was explanted, and intravitreal cultures showed P. acnes growth after 5 days. Intravitreal antibiotics treated the infection successfully. CONCLUSIONS: To our knowledge, this is the first reported case of chronic, post-operative endophthalmitis in a patient with an iris prosthesis. Chronic, post-operative endophthalmitis may be a difficult to identify in the context of traumatic aniridia and iris prosthesis implantation due to other potential etiologies of chronic intraocular inflammation such as implant-induced chafing. Clinicians should suspect chronic, post-operative endophthalmitis in any case of recurrent, low-grade intraocular inflammation.
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Aniridia , Endoftalmitis/etiología , Infecciones por Bacterias Grampositivas/etiología , Implantación de Prótesis/efectos adversos , Aniridia/etiología , Aniridia/cirugía , Remoción de Dispositivos , Lesiones Oculares/cirugía , Humanos , Iris/cirugía , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/microbiología , Propionibacterium acnes/aislamiento & purificaciónRESUMEN
BACKGROUND: The custom-made, flexible artificial iris developed by HumanOptics and Koch can reconstruct the anterior segment of patients with aniridia. The aim of this study was to evaluate the long-term clinical outcome and complication spectrum after artificial iris implantation and the role of the embedded fiber mesh in view of specific complications. METHODS: In this retrospective interventional case series, patients received an artificial iris between 2004 and 2013. Only eyes with a minimum follow-up period of 2 years were included. Indications were congenital, traumatic, or iatrogenic aniridia. The artificial iris was used either with or without embedded fiber mesh for partial or full prostheses. RESULTS: We included 34 patients (mean age 48.8 years; SD ±17.2) with a mean follow-up of 50.0 months (SD ±18.9 months). No repositioning of prostheses was necessary. In cases of keratopathy (17.6 %) visual function increased from baseline mean 1.6 logMAR (SD ±0.7) to 1.2 logMAR (SD ±0.7) after artificial iris implantation. The remaining iris tissue darkened during the follow-up in 23.5 % (83.3 % with and 10.7 % without mesh), 8.8 % developed glaucoma (50 % with and 0 % without mesh) and 14.7 % needed consecutive surgery after prostheses implantation (50 % with and 7.1 % without mesh). In three out of seven trauma cases (42.9 %) silicone oil was spilled into the anterior chamber after 2.5 years on average. CONCLUSION: The artificial iris prosthesis revealed a good clinical outcome in terms of long-term stability, cosmetic appearance, visual function, and represents a good functional iris diaphragm for compartmentalisation. Complications such as glaucoma, darkening of iris tissue, and need for consecutive anterior segment surgery are clearly associated with implants with integrated fiber mesh, but not to those without. Hence, the use of full iris prostheses without embedded fiber mesh, even in cases with remnant iris, and the use of slightly smaller implants than officially recommended may be beneficial.
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Aniridia/cirugía , Órganos Artificiales , Procedimientos Quirúrgicos Oftalmológicos/métodos , Implantación de Prótesis/métodos , Agudeza Visual , Adulto , Anciano , Anciano de 80 o más Años , Aniridia/diagnóstico , Aniridia/fisiopatología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: Posttraumatic partial or total iris defects often cause significant debilitating glare, photophobia, decreased vision and cosmetic problems. Currently, the best cosmetic results can be obtained with a customized silicone iris prosthesis. However, little is known about the functional results and the rate of complication if this type of iris prosthesis is implanted into severely traumatized eyes. The aim of this study is to analyse the functional and cosmetic outcomes as well as complications after Artificial Iris implantation. METHODS: A consecutive series of 34 patients who received a customized silicone iris prosthesis after severe globe injury with total or sub-total iris loss was analysed retrospectively. Additionally, patients were interviewed regarding change in subjective complaints. RESULTS: Median follow-up was 24 months (range 12.0-48.8). Mean visual acuity prior to Artificial Iris implantation was 1.1 logMAR (range 0.3-2.6). Five patients (15%) had pre-existing glaucoma and eight patients (24%) had pre-existing hypotony. Visual acuity 12 months after surgery was 1.4 logMAR (range 0.2-2.6). Complications included newly diagnosed glaucoma in three eyes (9%) and hypotony in three eyes (9%), persisting intraocular inflammation or macular oedema in seven patients (21%), and corneal endothelial decompensation requiring corneal transplantation in six patients (18%). Patients' satisfaction increased by reducing glare and enhanced cosmetic appearance. CONCLUSION: The customized silicone iris prosthesis is an individualized treatment approach with appealing cosmetic results. Therefore, especially traumatized eyes with highly different posttraumatic conditions could benefit. However, in some patients, the implantation of this device may cause an increase of intraocular pressure, corneal endothelial decompensation or persisting inflammation.
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Órganos Artificiales , Lesiones Oculares Penetrantes/cirugía , Complicaciones Intraoperatorias , Iris/lesiones , Complicaciones Posoperatorias , Implantación de Prótesis , Elastómeros de Silicona , Estudios de Seguimiento , Humanos , Satisfacción del Paciente , Resultado del Tratamiento , Agudeza Visual/fisiologíaRESUMEN
Iris defects with their disturbed pupillary function, visual impairment and glare constitute a therapeutic challenge in surgical reconstruction. A new therapeutic option for distinctive defects consists in the implantation of a custom-made silicone iris. This new and challenging therapy provides the opportunity to achieve an individual, aesthetically appealing and good functional result for the patient.