Skip to main content

  • Favorable Findings for the Artificial Iris

    By Lynda Seminara
    Selected by Russell N. Van Gelder, MD, PhD
    Add to My Bookmarks

    Journal Highlights

    Ophthalmology, June 2022

    Download PDF

    In an FDA-sanctioned multicenter pro­spective study, Ayres et al. looked at the safety and efficacy of the CustomFlex Artificial Iris for managing partial or full defects of the iris in adults. The device met all key endpoints for efficacy and surpassed its main safety endpoints.

    Included in the study were adults with a congenital or acquired iris defect (partial or complete) that caused pho-tophobia and/or glare sensitivity. All patients underwent implantation of the foldable artificial iris during a four-year period (ending Dec. 1, 2017). The devices were implanted with forceps or an IOL injector. The fixation method was determined preoperatively by ana­tomic features of the anterior segment. The chosen technique could be passive fixation within the capsular bag; passive fixation within the ciliary sulcus; or active fixation to residual iris tissue, the sclera, or an IOL that was then sutured to the sclera. Partial iris-segment im­plantation was not used in this study. In no case was the device placed in the anterior chamber angle or in a phakic eye.

    After implantation, patients were evaluated on day 1, week 1, and months 1, 3, 6, and 12. At each assessment, slit-lamp findings, IOP, implant position, visual symptoms (subjective), and complications were documented. Ad­ditional safety measures were corrected distance visual acuity (CDVA) and en­dothelial cell density (ECD) at months 3, 6, or 12. Patients completed the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) to assess their quality of life and rated their cosmetic results using the Global Aesthetic Improvement Scale. Main outcomes were photosensitivity and glare results, visual symptoms, NEI VFQ-25 scores, global improvement ratings, and adverse events associated with the prosthesis, the IOL, and the surgery itself.

    By 12 months post-op, marked to severe daytime and nighttime light sensitivity were reduced by 59.7% and 41.5%, respectively (both p < .0001). Severe daytime and nighttime glare were reduced by 53.1% and 48.5%, respec­tively (both p < .0001). The mean NEI VFQ-25 total score improved 15.4 points, and 93.8% of patients reported improvement in cosmesis. No patient lost more than 2 lines of CDVA, and the median ECD loss was 5.3% at six months and 7.2% at 12 months.

    Despite these outcomes, the authors noted that residual iris retraction syn­drome can occur with this procedure, which may lead to elevated IOP and recurrent hyphema. However, this was not observed in the present study.

    The original article can be found here.