Reper artificial iris model C as an alternative treatment of traumatic aniridia and aphakia: a case series

Technical Summary: Reper Artificial Iris Model C for Traumatic Aniridia and Aphakia

Problem Statement
Traumatic aniridia, often accompanied by aphakia (absence of the crystalline lens) or intraocular lens (IOL) subluxation, presents significant clinical challenges. Patients typically suffer from debilitating photophobia, glare sensitivity, reduced visual quality, and poor contrast sensitivity. Furthermore, the condition carries risks of secondary complications such as glaucoma due to angle recession or pigment dispersion. While various surgical solutions exist, including PMMA and silicone implants, they often present limitations such as the need for large incisions, separate IOL implantation, or higher rates of specific complications like fibrin reactions or lens deposits. There is a need for a foldable, integrated solution that addresses both the iris defect and the refractive error while minimizing surgical trauma and improving long-term stability.

Methodology
This study is a retrospective case series conducted at the Jules-Gonin Eye Hospital in Lausanne, Switzerland, involving four patients with unilateral traumatic aniridia and aphakia treated between October 2021 and September 2024.

• Intervention: All patients underwent implantation of the Reper Artificial Iris Model C. This prosthesis is a foldable, biconvex hydrophobic acrylic copolymer with a 13.5 mm total diameter and a 3.5 mm optic. It features a 3-point haptic fixation designed for the ciliary sulcus, distinguishing it from models requiring capsular bag fixation. The device is available with integrated optical correction (Model C1, up to +40D) or without (Model C0).
• Surgical Technique: Procedures were performed under general anesthesia by a single surgeon using a three-point scleral fixation technique with Hoffman pockets. The foldable prosthesis was secured using 10-0 nylon sutures in an ab-externo manner to ensure centration.
  • In cases requiring concurrent penetrating keratoplasty (three of four cases), an open-sky technique was utilized. The artificial iris was implanted first, followed by corneal graft placement and fixation with 16 interrupted sutures, utilizing a Flieringa ring to maintain globe volume.
  • In the non-keratoplasty case, an anterior chamber maintainer was used to prevent hypotony in a vitrectomized eye.
• Postoperative Care: Patients received standard topical antibiotics, corticosteroids, and artificial tears. Follow-up included assessments of visual acuity, intraocular pressure (IOP), and anterior segment health at intervals ranging from one day to 30 months.

Key Contributions
The paper provides a detailed clinical evaluation of the Reper Artificial Iris Model C, specifically highlighting its utility as an integrated iris-lens diaphragm. Key technical contributions include:

1. Integrated Solution: Demonstrating the efficacy of a single device that simultaneously corrects the iris defect and provides refractive correction, eliminating the need for separate IOL fixation in aphakic eyes.
2. Surgical Protocol: Outlining a specific surgical workflow combining scleral-fixated artificial iris implantation with penetrating keratoplasty using an open-sky technique.
3. Comparative Context: Positioning the Reper Model C against existing market options (Morcher PMMA and CustomFlex silicone), noting its foldable nature, hydrophobic acrylic composition, and CE approval status.

Results

• Visual and Symptomatic Outcomes: All four patients experienced marked improvements in best-corrected visual acuity (BCVA), with postoperative values ranging from 0.5 to 1.25 decimal units. Patients reported significant resolution or reduction of photophobia and glare. Cosmetic satisfaction was universally high.
• Stability: All iris prostheses remained stable and well-centered throughout the follow-up period. No cystoid macular edema was detected on OCT.
• Complications:
  • No intraoperative or immediate postoperative complications occurred.
  • One patient with pre-existing glaucoma experienced persistently elevated IOP (30–40 mmHg) despite maximal medical therapy, eventually requiring cyclophotocoagulation for control.
  • One patient developed significant corneal graft edema 30 months postoperatively due to endothelial decompensation, necessitating a secondary posterior lamellar keratoplasty (DSAEK).
  • One patient experienced transient corneal graft rejection and another transient IOP elevation, both managed successfully with medical intervention.

Significance and Claims
The authors conclude that the Reper Artificial Iris Model C represents a safe and effective alternative treatment for patients with traumatic aniridia and aphakia. The study claims the device offers advantages over other market options, particularly its ability to be combined effectively with full-thickness corneal transplantation and its provision of integrated optical correction.

However, the paper maintains a modest tone regarding its broader implications. The authors explicitly acknowledge limitations, including the retrospective design, small sample size (n=4), and the absence of a control group. Consequently, they state that while the results are promising, larger prospective comparative studies are required to definitively confirm the long-term safety and efficacy of the Reper Model C relative to other surgical options. The paper does not claim to have solved all complications associated with aniridia but suggests this device is a viable and efficient option within the current therapeutic landscape.