Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris.

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.

PARS PLANA VITRECTOMY THROUGH A CUSTOM FLEXIBLE IRIS PROSTHESIS.

PURPOSE: To demonstrate the outcomes of pars plana vitrectomy in patients with custom flexible iris prosthesis (CFIP). METHODS: The medical records of patients who underwent CFIP placement were retrospectively reviewed. Patients who underwent pars plana vitrectomy concurrent with or after placement of CFIP were identified. Preoperative, intraoperative, and postoperative parameters were analyzed. Surgeons were surveyed regarding the technical aspects of the vitreoretinal surgery. Outcome measures included: anatomic success, complications, surgeon-rated ease of visualization through CFIP during pars plana vitrectomy, and Snellen best-corrected visual acuity. RESULTS: Twenty-four surgeries were performed in 20 eyes of 20 patients. Postoperative best-corrected visual acuity improved in 11 eyes (55%), remained unchanged in 5 eyes (25%), and declined in 4 eyes (20%) after a mean follow-up of 16.1 ± 16.\nths (range: 3-53 months). No intraoperative complications were noted. Short-term anatomical success was 100%. Postoperative complications occurred in five eyes (recurrent retinal detachment in three eyes, recurrent epiretinal membrane in 1 eye, and CFIP and intraocular lens subluxation in 1 eye). CONCLUSION: Visualization for pars plana vitrectomy with the assistance of both direct and wide angle viewing systems through the 3.35 mm pseudopupil of a CFIP is viable in the surgical management of complex vitreoretinal diseases.

Evaluation of a New Controlled Point Source LED Glare Tester for Disability Glare Detection in Participants With and Without Cataracts.

PURPOSE: To determine glare-induced change during visual acuity testing in patients with and without cataract using the controlled point source light-emitting diode (LED) glare tester (EpiGlare Tester; Epico, LLC, Columbus, OH), a new medical device for identification of glare disability. METHODS: This prospective, multicenter study enrolled 40 patients (80 eyes with cataracts) and 49 control subjects (98 eyes without cataracts). Corrected distance visual acuity (CDVA) was measured with and without glare using the EpiGlare Tester as a glare source. Functional visual ability was evaluated using driving and glare subscales from the Refractive Status Vision Profile questionnaire. The primary efficacy measure was change in CDVA measurement with and without glare in patients with senile cataract compared to participants without cataract. Secondary efficacy measures included correlation of the CDVA change caused by functional glare disability and subjective patient and investigator assessments. RESULTS: CDVA reduction was greater for patients with cataract, with a mean reduction of -0.49 ± 0.3 logMAR, than for participants without cataracts at -0.13 ± 0.2 logMAR (P < .001). This equates to a 5-line Snellen reduction (0.49 logMAR) in patients with cataracts and a 1-line reduction (-0.13 logMAR) in patients without cataracts. Among patients with cataracts, 83% stated the device accurately represented the difficulty experienced while driving at night (P < .001); among participants without cataracts, 71% reported being minimally affected by glare from the device (P = .003). CONCLUSIONS: A new controlled point source LED glare tester demonstrated the adverse effect on visual acuity due to glare in patients with cataract, accurately simulated night driving glare issues for patients with cataracts, and was rated as easy to use and useful by investigators.

Stability of the acrysof toric intraocular lens in combined cataract surgery and transconjunctival sutureless vitrectomy.

PURPOSE: To report the outcomes of combined cataract surgery with toric intraocular lens (IOL) implantation when performed in conjunction with transconjunctival sutureless pars plana vitrectomy. DESIGN: Retrospective interventional case series. PARTICIPANTS: Consecutive series of 55 eyes of 51 patients from April 2007 to December of 2010. METHODS: All eyes underwent combined simultaneous small incision cataract surgery, toric IOL implantation, and transconjunctival sutureless vitrectomy surgery. MAIN OUTCOME MEASURES: Postoperative visual acuity, postoperative astigmatism, and rotational stability of the IOL. RESULTS: Preoperative best-corrected visual acuity was 0.32 ± 0.15 logMar (Snellen 20/43) and improved to 0.16 ± 0.10 (Snellen 20/29) postoperatively uncorrected (P < 0.01) and to 0.08 ± 0.11 best-corrected (Snellen 20/24) (P < 0.01). Preoperative astigmatism was 1.75 ± 1.0 diopters (D) (range, 0-4.75 D) and improved to 0.5 ± 0.50 D (range, 0-2.5 D) postoperatively (P < 0.01). Final measured postoperative IOL axis deviation from target axis was 4 ± 6° (range, 0-32). Final IOL axis was within 5° of target in 47 (85%) eyes, within 10 degrees of target in 51 (93%) eyes, and was within 15° of target in 52 (95%) eyes. CONCLUSION: Toric lens position and axis remained stable after implantation during combined cataract surgery and transconjunctival sutureless vitrectomy.

The clinical characterization and surgical correction of blepharoptosis associated with congenital aniridia.

PURPOSE: To document the clinical characteristics and describe our management of patients with blepharoptosis associated with congenital aniridia. METHODS: Consecutive retrospective case series of patients with congenital aniridia seen at a single institution (Cincinnati Eye Institute) from 1963 to 2010. Surgical correction was performed by 2 surgeons (J.A.N. and R.C.K.). RESULTS: Ptosis associated with congenital aniridia is marked with decreased levator function. Significant comorbid ophthalmologic disease was invariably present, particularly aniridia-associated keratopathy. Complications, most often keratopathy, were common, even following conservative correction. CONCLUSIONS: The degree of ptosis is significant, and levator function is typically reduced. Ocular surface viability appears to play a key role in preoperative, intraoperative, and postoperative management. While we are aware that congenital aniridia is rather rare, we believe these recommendations are generalizable to patients with severe ocular surface disease.

Late Iris Cerclage Suture Cheese-Wiring.

PURPOSE: Mydriatic pupil repair by cerclage has been thought to be a permanent fix for glare, visual function and cosmesis. Iris repair can develop late cheese-wiring of cerclage sutures with resultant loss of benefits. We describe a case series of cerclage failures due to cheese-wiring. SETTING: Cincinnati Eye Institute, Cincinnati, Ohio. DESIGN: Retrospective single-surgeon case series. METHODS: A retrospective chart review sought patients that underwent iris cerclage at the Cincinnati Eye Institute who later developed suture cheese-wiring. The patient symptoms, demographics, cerclage size, suture type, knot type, iris status, and suture status at final follow up were ascertained. RESULTS: Six cases of cerclage suture cheese-wiring with loss of the original surgical benefit were identified. 10-0 polypropylene suture and a 3-1-1 knot were utilized in each case. The suture remained intact with an intact knot and suture loop in all cases. CONCLUSION: Cheese-wiring with return of mydriasis is a potential long-term outcome of iris cerclage suture placement, with return of pre-operative symptoms. Awareness of this potential eventuality provides physicians and patients a broader perspective when selecting between cerclage suture, iris prosthesis placement or other surgical and non-surgical options.

Microscopic analysis of preinsertion cutting modalities on custom, flexible iris prostheses.

PURPOSE: To determine the induced edge effects of different clinically used device postmanufacture modification styles and modalities on custom iris implants. SETTINGS: An academically affiliated multispecialty private practice group and an academic medical center. DESIGN: Laboratory study. METHODS: Sample custom iris prostheses were cut using patterns, blades, and surgical instruments described in the literature. The cut edges were evaluated with slitlamp microscopy, light microscopy, and scanning electron microscopy. RESULTS: Disposable blades yielded smoother cuts than scissors. Trephine blade brand significantly affected the cut surface smoothness of the silicone matrix. Meshwork-embedded prostheses had some irregular sharp edges where the mesh fibers were cut with all modalities, although these were worse with scissors and one tested trephine brand compared with the other. Pseudoiridectomies and scissor cuts created sharp points and corners in the device periphery. CONCLUSIONS: Postmanufacture modifications of iris implants should be minimized. The cut margins of the fiber-free implants have fewer sharp edges and may be preferable for sulcus placement. In-the-bag device placement may mitigate clinical impact of sharp edges and corners. These practices may help to minimize inflammatory sequelae postimplantation.

Prospective multicenter study of toric IOL outcomes when dual zone automated keratometry is used for astigmatism planning.

PURPOSE: To evaluate clinical outcomes when toric intraocular lens (IOL) calculations are based on the keratometric output from the Lenstar LS-900 dual zone automated keratometer (Haag-Streit AG, Koeniz, Switzerland). METHODS: Eligible subjects presenting for toric IOL implantation at five sites were measured with a dual-zone automated keratometer. The data were used to plan the power and angle of the toric IOL to be implanted. Refractive and visual acuity status were checked at 1 and 3 months postoperatively. RESULTS: A total of 102 eyes had relevant data for analysis. More than 76% of eyes had 0.50 diopter or less of refractive astigmatism at 1 and 3 months, with no difference by level of astigmatism corrected. More than half of the eyes had uncorrected distance visual acuity of 20/20 or better and 78% were 20/25 or better. A new measure of effectiveness of toric correction power is described that suggested lens selection was appropriate. Results appeared better than those obtained in previous studies when the IOL cylinder power and alignment were calculated using manual keratometry. CONCLUSIONS: In this series of eyes from multiple centers, the calculation of toric IOL power using dual-zone automated keratometry measurements produced clinical results that were better than results in the literature where manual keratometry was used.

Scleral suture fixation of a custom, flexible iris prosthesis.

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.

Structural effects on custom, flexible iris prostheses passing through injector systems.

PURPOSE: To determine the suitability of various commercially available intraocular lens injection systems for the implantation of custom, flexible artificial irides of various sizes, both with and without fiber meshwork. SETTING: Cincinnati Eye Institute, Blue Ash, Ohio. DESIGN: Laboratory study. METHODS: Custom, flexible iris prostheses, both with and without fiber meshwork, were either maintained at a 12.8 mm diameter or trephinated to a 10 mm diameter and subsequently inserted through 7 different intraocular lens injector systems. The ease of load, difficulty of injection, control of injection, and level of prosthetic distortion, if any, were observed and recorded. RESULTS: The fiber-free devices universally passed through the injectors unaffected. Each of the iris prostheses with embedded fiber meshwork appeared grossly distorted after injection. The injection systems had differing amounts of effort to load the device into the cartridge, to advance the prosthetic through the system, and varying levels of control when the prosthetic was released, although all the systems delivered the device effectively. CONCLUSIONS: Any of the 7 injection systems tested in this study can be used effectively for fiber-free artificial irides. Caution should be taken to ensure that control of insertion is maintained throughout the injection process. Screw-type injectors required less effort and yielded more control than plunger-type injector. Fiber meshwork-containing artificial irides should not be inserted through an injector.

A peculiar case of aqueous misdirection from a pseudophakic secluded pupil in a patient with chronic angle closure glaucoma.

Purpose: To explore the course of a pseudophakic and pseudoiridic 61-year-old man with a history of open angle glaucoma in his right eye who developed a sub-totally secluded pupil then later presented with angle closure, a significant pressure spike, and a marked myopic refractive shift, consistent with aqueous misdirection. Observations: Goniosynechialysis, surgical removal of much of the native peripheral iris, and zonulohyaloidectomy led to a return to his prior refraction and improve intraocular pressure (IOP) control. Conclusions and Importance: This case demonstrates that a diagnosis of aqueous misdirection should not be disregarded in the presence of a prior vitrectomy and that aqueous misdirection should be strongly considered in cases of elevated IOP with a patent peripheral iridotomy, myopic shift and angle narrowing.

Intraocular methotrexate for epithelial downgrowth: long-term outcomes in a multicentre case series.

BACKGROUND/AIMS: Sheet-like type of epithelial downgrowth (EDG) is not easily amenable to surgical excision. We describe long-term outcomes in patients with EDG treated with intraocular methotrexate (MTX). METHODS: This is a retrospective, multicentric case series including 10 eyes (nine patients) treated with intraocular MTX for sheet-like EDG. Relevant ocular history, previous EDG treatments, MTX injection regimen, long-term outcomes and complications are reported. RESULTS: All cases were associated with intraocular surgery. Most patients were treated with 400 µm/0.1 mL MTX injections with a starting frequency of two times per week or weekly injections. Mean and SD number of injections per eye was 16±13 injections and duration of follow-up was 54±36 months (range: 7-120 months). Eradication of EDG was achieved in seven eyes of which one required a second MTX treatment course to achieve eradication, while clinical resolution with recurrence was observed in two. One treatment failure occurred despite eight weekly injections which slowed but did not halt EDG progression; the patient later requested that treatments be stopped given difficulty to come to follow-ups. Surface epitheliopathy developed in eight patients and was used to titrate MTX treatment. Six patients also developed endothelial failure. CONCLUSION: We report the largest case series of diffuse, sheet-like EDG treated with intraocular MTX with follow-ups up to 10 years. Intraocular MTX may be used effectively to achieve eradication of EDG in cases where surgery is not amenable. However, further recommendations to guide treatment remain warranted.

In-the-bag injection and overfold technique for custom flexible prosthetic iris prostheses.

In-the-bag placement is the ideal location for an anterior segment implant, including the custom flexible artificial iris prosthesis (CUSTOMFLEX ARTIFICIALIRIS). Yet, an injection of a bag-filling iris device through a reasonably sized capsulorhexis creates a geometric challenge. First, the device must be placed into an injection cartridge. Folding into a conoid, trifold orientation improves the facility with which the device is loaded into the injector barrel. To facilitate placement into the capsular bag, the device that is approximately 10+ mm is injected into the nasal bag, and the temporal portion is overfolded on itself to reduce its outer diameter.

Lamellar Dissection Technique for Traumatic Cataract With Corneal Incarceration.

PURPOSE: To describe a technique for traumatic cataract management for cases in which part of the anterior capsule has been incarcerated into a healed corneal laceration. METHODS: This is a single-center retrospective chart review of 3 patients with capsular/corneal incarceration after penetrating injury. Each patient underwent primary globe repair, followed by subsequent cataract surgery with intraocular lens (IOL) and iris prosthesis placement. The main outcome measure was corrected distance visual acuity. RESULTS: At a mean of 19-month postoperative follow-up (range 12-26 mo), corrected distance visual acuity ranged from 20/25 to 20/80 and all patients had improved vision compared with before cataract surgery. At the final follow-up, all IOLs and iris prostheses were in stable position and no eyes required corneal transplantation. CONCLUSIONS: Traumatic cataracts may be complicated by incarceration of the anterior capsule into the cornea. Incorporating the posterior aspect of the cornea into the anterior capsulotomy enables cataract removal and IOL placement in a stable capsular bag complex.

COMBINED PHACOEMULSIFICATION SURGERY WITH MULTIFOCAL INTRAOCULAR LENS IMPLANTATION AND PARS PLANA VITRECTOMY FOR SYMPTOMATIC VITREOUS OPACITIES.

PURPOSE: To report surgical outcomes of combined vitrectomy for vitreous floaters and phacoemulsification surgery with multifocal intraocular lens implantation. METHODS: Retrospective, interventional, noncomparative case series of five eyes from five patients who underwent same-day combined phacoemulsification surgeries with apodized, diffractive multifocal intraocular lens implantation for cataract and pars plana vitrectomy for symptomatic vitreous opacities, that is, floaters. Primary outcomes were distance and near visual acuities, and resolution of symptoms. Secondary outcomes included intraocular pressure, refractive outcomes, and surgical complications. RESULTS: Mean logarithm of the minimum angle of resolution glare distance visual acuity improved from 0.36 (best-corrected Snellen 20/47) preoperatively to an uncorrected distance visual acuity of 0.05 (Snellen 20/23) at 6 months postoperatively (P = 0.042). All but one patient achieved multifocality with a near visual acuity of J2 or better. All patients noted subjective improvement in symptoms from floaters postoperatively. Mean intraocular pressure remained stable during follow-up. Two eyes ultimately required YAG capsulotomies for symptomatic posterior capsular opacification, one of which additionally received LASEK for refractive correction. CONCLUSION: Multifocality and improvement in symptoms from symptomatic vitreous opacities were observed in this pilot series of carefully selected patients who underwent combined phacovitrectomy with multifocal intraocular lens implantation. A high rate of retinal tears was found in these patients. Appropriate caution should be taken in preoperative assessment and patient selection for the combined procedure.

Management of common iatrogenic iris defects induced by cataract surgery.

The proximity of the iris to the instruments and currents of cataract surgery makes iatrogenic damage to the iris a common complication of cataract surgery. This article discusses techniques to prevent or minimize this damage. When damage does occur, the surgeon must decide if, when, and how to repair the damage. Principles governing these decisions and techniques for repair are discussed. Figures and videos, included as online Supplemental Data files, illustrate cases of iatrogenic damage and repair techniques.

Long-term follow-up of a custom-made prosthetic iris device in patients with congenital aniridia.

PURPOSE: To investigate the effectiveness and safety of a custom-made iris prosthetic device used to reduce photic symptoms in patients with congenital aniridia. SETTING: Cincinnati Eye Institute, Cincinnati, Ohio, USA. DESIGN: Retrospective single-surgeon case series. METHODS: The charts of all eyes of patients diagnosed with congenital aniridia syndrome who underwent implantation of the custom-made iris prosthesis at the setting institution between 2008 and 2018 were reviewed. Eyes with more than 6 months of follow-up were included in evaluation. Charts were carefully reviewed for comorbid conditions, interventions, and outcomes. RESULTS: Ninety-six eyes of 50 patients were included in the study. Subjective reduction in photophobia and glare was reported in 95.7% and 95.2% of cases, respectively. The incidence of aniridia fibrosis syndrome (AFS) in this study (3.1%; 95% confidence interval, 0.6%-8.9%) was similar to previous studies in the literature. CONCLUSIONS: The custom-made iris prosthesis was an effective and safe option to reduce photic symptoms in patients with congenital aniridia. The custom, flexible iris implant does not appear to alter the risk for AFS. These highly complex eyes with significant comorbid pathologies demand an individualized approach and careful long-term follow-up.

Partial-thickness scleral tethering suture for optimum fixation and centration of transscleral-sutured intraocular lens-capsule complex.

We describe a surgical technique for fine-tuning the centration of a transscleral-sutured modified capsular tension ring (CTR)-intraocular lens-capsular bag complex using a partial-thickness scleral tethering suture placed posterior to the external episcleral portion of a transscleral suture loop. The technique can be used for adjusting the centration of any intraocular supporting or prosthetic device that is transsclerally sutured in a "hanging" technique, such as capsular tension segments, modified CTRs, capsular anchoring devices, or iris prostheses.