Intraocular lenses undergo rigorous safety testing before market approval, though are sometimes modified by surgeons post-manufacture in practice. This includes techniques such as haptic curing, IOL "punch," and trans-optic suture passage. We employed reported techniques to modify IOLs and imaged them with a scanning electron microscope. We found that the cured haptic was asymmetric and not as wide as expected for the degree of melt, thus not as robust to prevent possible haptic intrusion. The IOL "punch" created sharp edges, a radial matrix crack, irregular debris, and sharp shards of acrylic emanating from the edges. The mattress suture caused disruption at suture entry and exit points as well as surface undulation overlying the intra-optic suture pass. Post-manufacture modification of IOLs changes morphology and surface topography, which may affect IOL position, tolerance, optical function, and/or inflammatory potential. Surgeons should be aware of these possible consequences when considering post-manufacture modification of IOLs.

In patients with iris deficiencies, surgical placement of a custom, artificial iris improves cosmesis and photic symptoms. When patients have existing intraocular lenses (IOLs) within the capsular bag, iris devices also placed within the capsular bag might change the IOL’s effectivity; previous reports suggest a hyperopic shift, but data is limited. This retrospective chart review studied 13 eyes receiving a custom, flexible iris prosthesis fixated into an existing intact capsular bag, separate from prior phacoemulsification. Biometry, IOL data, and pre- and post-operative refraction were collected. For iris prosthesis placement without concomitant procedures, the average change in spherical equivalent was +0.49D; For an aphakic eye receiving a secondary IOL, post-operative refraction was +0.79D more hyperopic than expected. For eyes undergoing concomitant IOL exchange, average post-operative refraction was 1.22D less myopic than predicted. This study confirms a hyperopic refractive shift when both IOLs and iris prostheses are placed into the capsular bag.

Purpose: Anterior stromal puncture is an inexpensive and widely used technique at the slit lamp to treat recurrent corneal erosions (RCE), common sequelae of corneal abrasions, trauma, and epithelial basement membrane dystrophies (EBMDs). The purpose of this study was to determine safety of a novel anterior stromal micropuncture device (termed a “plexitome”) for use in the optical axis of the cornea. Methods: We performed an IRB-approved clinical pilot study on 45 patients with diverse corneal pathologies to determine the safety of the plexitome device and examined corneal healing responses clinically for a minimum of 30 days after treatment. Follow on efficacy data was collected for treated patients with RCE. Micropuncture treatment was performed either through loose epithelial tissue or after debridement using a cotton tip at the slit lamp. After “imprinting,” patients were treated with topical medications including antibiotics, hypertonic saline/ointment, bandage contact lenses, and/or patching according to the treating physician's routine care for the condition. Results: Micropuncture using the “plexitome” device did not create visible scars in the corneal stroma of the 45 patients treated and followed for at least 30 days. Photographic evidence of imprinting was seen at in 1 patient at 30 days. There were no significant adverse events associated with treatment. Conclusions: Micropuncture of the cornea using the “plexitome” device does not create optically evident anterior stromal scarring after treatment. Micropuncture using the device may be an effective way of treating RCE and other corneal manifestations of EBMD in the optical axis, which is not currently possible using standard anterior stromal puncture methods.

Full-thickness keratoplasties remain fraught with wound healing and optical problems. We report an enhanced mushroom keratoplasty technique, which maintains a wide anterior optical component of the graft and a smaller internal graft diameter, maximizing preserved host endothelium and graft host junction area. A comparative mathematical modeling of spherical caps and cylindrical areas were calculated for traditional, mushroom, and extreme mushroom keratoplasty techniques. An index case was identified, and its long-term follow-up was reviewed. Greater anterior-posterior trephination disparities provide a refractive advantage while increasing graft host junction and retained host endothelium areas. A case of traumatic, full-thickness axial corneal scarring treated with an extreme mushroom, penetrating keratoplasty had an acute graft rejection at 1 month and failed. Over 18 months, the cornea cleared, and clarity remains at 10 years (and counting). Increased contact area for stromal healing and retention of host endothelial reserve are maximized in extreme mushroom keratoplasty. A representative case demonstrates excellent optical performance without irregular astigmatism and the ability for residual host endothelium to clear a failed graft and has sustained long-term clarity after that.

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.

A 56-year-old man with a history of myopic LASIK presented with left eye gradual blurring of vision over 3 months. There was no history of trauma. His uncorrected visual acuities were 20/25 in the right eye and 20/400 in the left eye. The right eye was normal except for an early cataract. The left eye had a moderate cataract that was phacodonetic. Vitreous was present in the shallow anterior chamber (AC) (Figure 1 JOURNAL/jcrs/04.03/02158034-202405000-00018/figure1/v/2024-04-22T135154Z/r/image-tiff ). The fundus was normal. The intraocular pressures (IOPs) were 14 mm Hg in the right eye and 20 mm Hg in the left eye. Ultrasound biomicroscopy of the anterior segment in the left eye revealed near total zonular loss with few intact zonular strands at the 6 and 10 o'clock regions (Figure 2 JOURNAL/jcrs/04.03/02158034-202405000-00018/figure2/v/2024-04-22T135154Z/r/image-tiff ). Vitreous was observed in the AC, herniating mostly from the 3 o'clock region. The endothelial cell density and optical coherence tomography (OCT) of the macular and disc in both eyes were normal. Central corneal thickness was 527 µm in the right eye and 520 µm in the left eye. Describe how you would manage this case surgically. Optical biometry had been obtained, and the axial length in both eyes was similar. Discuss how you would select the monofocal intraocular lens (IOL) diopter (D) targeted for −1.50 D if the AC depth in the left eye was 2.48 mm and in the right eye was 3.25 mm.

Purpose: To describe a case series of cerclage failures due to cheese-wiring; iris repair can develop late cheese-wiring of cerclage sutures with resultant loss of benefits. Setting: Cincinnati Eye Institute, Cincinnati, Ohio. Design: Retrospective single-surgeon case series. Methods: A retrospective chart review sought patients who 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: 6 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 used in each case. The suture remained intact with an intact knot and suture loop in all cases. Conclusions: Cheese-wiring with return of mydriasis is a potential long-term outcome of iris cerclage suture placement, with return of preoperative 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 nonsurgical options.

We read with interest the article by Gius et al.1 Although we appreciate the authors' efforts to review the current literature on different iris prostheses, we must point out that comparing multiple devices in a scenario of nonstandardized methodology can lead to scientifically flawed conclusions. Glare is a highly subjective symptom, and as such, the direct comparison in the absence of a standard validated questionnaire is of minimal scientific value. To illustrate our point, we can focus on the authors' conclusion that the HumanOptics prosthesis leads to lower improvement of glare when compared with other prosthetic iris devices (PIDs). The potential of a PID to reduce glare is directly proportional to the amount of light that it blocks from entering the optic system; therefore, it is not scientifically plausible that 2 alternated Morcher 50c aniridia rings creating a total surface area of 50.27 mm2 could improve glare greater than the HumanOptics device and its total surface area of 119.87 mm2. One may argue that the apparent inferior results with this device are a reflection of more rigorous methodology in U.S. Food and Drug Administration (FDA) clinical trials as this is the only PID to have ever undergone FDA scrutiny.2 Similarly, the comparison of aesthetic outcomes is of little value without a standard questionnaire. Glaucoma frequently develops in eyes with congenital or traumatic aniridia.3,4 The current available literature is insufficient to elucidate whether PIDs may contribute to glaucoma incidence or severity in these eyes as there is not a single article comparing cohorts of traumatic or congenital aniridic eyes with and without PIDs. Interestingly, in a long-term follow-up of congenital aniridic patients with the HumanOptics device, we found glaucoma incidence rates similar to those in the available literature of congenital aniridia.5 We fail to hypothesize a pathogenesis pathway in which a foldable silicone prosthesis sequestered in the capsular bag may trigger glaucoma. In addition, a properly sized prosthesis fixated in the ciliary sulcus should not exert pressure on the ciliary body as proposed by the authors. There is not a single case of acute pseudo angle closure described. Furthermore, the multiple peripheral trephine punches to the HumanOptics device advocated by the authors create multiple sharp corners that can potentially induce uveitis–glaucoma–hyphema syndrome. Sadly, this opportunity fell short of describing the state of the art, including several devices which are no longer available worldwide, without noting which device are legacy while neglecting both the world's largest iris prosthesis trial (which also happens to be prospective and recent) and the world's largest single-pathology consecutive case series.2,5 It is safe to conclude that PIDs greatly improve quality of vision and life for patients with congenital or traumatic aniridia; however, direct comparison between multiple devices is not scientifically sound and impossible without uniform methodology. Surgeons can expect to deal with multiple comorbidities in these complex eyes; however, they should not be discouraged from offering these life-changing devices to their patients.

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.

PURPOSE To determine the induced edge effects of different clinically utilized device post-manufacture modification styles and modalities on custom iris implants. SETTINGS 1) Academically affiliated multispecialty private practice group, 2) 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 slit lamp microscopy, light microscopy, and scanning electron microscopy. RESULTS Disposable blades yielded smoother cuts than scissors. Trephine blade brand significantly impacted 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, though these were worse with scissors and one tested trephine brand compared to the other. Pseudo-iridectomies and scissor cuts created sharp points and corners in the device periphery. CONCLUSIONS Post-manufacture 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 post-implantation.

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. Copyright (c) 2023 Published by Wolters Kluwer on behalf of ASCRS and ESCRS

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.

Blankshain, Kimberly D. MD; Snyder, Michael E. MD; Miller, Daniel M. MD; Khatana, Anup K. MD Author Information

A 27-year-old woman had BrightOcular iris implants placed for cosmetic purposes that changed eye color from brown to blue bilaterally. Of note, BrightOcular implants are not approved by the U.S. Food and Drug Administration (FDA) for use in the United States and have been associated with severe ocular complications. In keeping with their design, they were placed in the anterior chamber (AC) in both eyes of this patient; surgery was performed outside the United States. As has been described previously and tragically in other cases, she developed chronic inflammation, intolerable glare, angle-closure glaucoma, corneal edema, and cataracts in both eyes. For medically unmanageable elevated intraocular pressure (IOP), she underwent diode laser cyclophotocoagulation (CPC) in both eyes, and eventually, an Ahmed tube shunt (New World Medical, Inc.) was placed in the right eye. Although she was advised and urged to have the iris implants removed, despite her ocular issues, she refused removal until intolerable glare and reduced vision ensued. Ultimately, both iris implants were extracted 5 years after implantation by a U.S. surgeon; the procedures resulted in corneal decompensation and progressive cataract development. Subsequent penetrating keratoplasty (PKP) was performed for the right eye, but it failed because of contact with the glaucoma tube shunt. She sought additional consultation and presented with the following findings: corrected distance visual acuity was 20/400 in the right eye and 20/40 in the left eye, IOP of 18 mm Hg in the right eye and 16 mm Hg in the left eye, pupils were nonreactive and fixed, and extraocular muscles and central visual field were normal. Pachymetry was 868 μm in the right eye and 653 μm in the left eye. Anterior segment examination in the right eye revealed a failed corneal graft with 3+ edema, peripheral anterior synechiae (PAS) for 360 degrees, shallow AC, Ahmed tube shunt at the 11 o'clock position and remnant iris adherent to the graft-host junction for 270 degrees, 3+ posterior subcapsular cataract, and 2+ cortical cataract (Figure 1JOURNAL/jcrs/04.03/02158034-202208000-00024/figure1/v/2022-08-01T210317Z/r/image-tiff). The sclera revealed multiple circular and circumferential atrophic blue spots consistent with high-energy transscleral CPC (Figure 2JOURNAL/jcrs/04.03/02158034-202208000-00024/figure2/v/2022-08-01T210317Z/r/image-tiff). In the left eye, she had remnant fixed dilated iris for 270 degrees, missing iris superiorly for 3 clock hours, an adequate AC, and 2+ cortical cataract (Figure 3JOURNAL/jcrs/04.03/02158034-202208000-00024/figure3/v/2022-08-01T210317Z/r/image-tiff). Posterior segment examination revealed a 0.5 cup-to-disc ratio in both eyes with normal vessels, macula, vitreous, and retinal periphery, bilaterally. Given this constellation of findings, how would you proceed?

Combined cataract surgery with vitrectomy is the preferred option for the management of posterior segment disease with concurrent cataract. While staged surgery is certainly possible, this chapter will review the advantages of combined phaco/vitrectomy and highlight techniques to make this approach the best and safest option for patients.

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, 10L, 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. (C) 2022 Published by Elsevier Inc. on behalf of the American Academy of Ophthalmology

Cincinnati Eye Institute, Cincinnati, OH Financial disclosures/conflicts of interest: None reported.

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.

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.