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Author(s): Bonnet, Clemence; Miller, Kevin M | Abstract: PurposeTo assess the preliminary safety and efficacy of custom silicone artificial iris implantation.SettingStein Eye Institute.DesignProspective consecutive case series.MethodsMedical records of patients implanted with the artificial iris were reviewed and followed for 1 year. Safety measures included corrected distance visual acuity (CDVA), intraocular pressure (IOP), endothelial cell count (ECC), surgical complications, secondary interventions, and adverse events (AEs). Efficacy measures included CDVA with glare, subjective daytime and nighttime glare graded from 0 to 10 (very significant), and subjective cosmetic appearance graded from 0 to 10 (very satisfied).ResultsTwenty eyes (19 patients) were implanted. Safety data were mixed. CDVA improved in 13 eyes and worsened in 6. ECC decreased from 1918 ± 870 to 1405 ± 705 cells/mm (P = .02). Eight eyes experienced postoperative complications. There were 4 IOP elevations, 2 corneal decompensations, 1 case of cystoid macular edema, and 1 device dislocation. Four eyes underwent secondary surgical interventions including 2 AEs (1 glaucoma surgery and 1 device dislocation). Efficacy outcomes were excellent. CDVA with glare improved from 1.5 ± 0.6 to 0.7 ± 0.8 logarithm of the minimum angle of resolution (P l .01). Mean subjective daytime glare decreased from 8.9 ± 1.8 to 2.7 ± 2.6 (P l .01) and nighttime glare decreased from 7.9 ± 1.8 to 2.5 ± 2.7 (P l .01). Mean cosmesis improved from 2.2 ± 1.6 to 8.8 ± 2.1 (P l .01).ConclusionsCustom artificial iris implantation was moderately risky but very effective at reducing light and glare sensitivity and in improving ocular cosmesis.

Purpose Iris intraocular implants were developed to manage congenital or traumatic iris defects. However, they are also used to change the color of patient eyes. The aim of this retrospective series was to report complications in patients managed in France after cosmetic implantation. Setting Ophthalmological institutions and private ophthalmologists in France. Design Multicenter retrospective observational study. Methods Questionnaires were sent to all ophthalmology departments in university hospitals and to private ophthalmologists. This questionnaire listed demographic and clinical data for each implanted eye with a focus on safety, the description of ocular complications (corneal edema, endothelial cell loss, increased intraocular pressure, and intraocular inflammation), and the therapeutic management implemented. Results Forty-four questionnaires (87 eyes) were collected, and ultimately, 33 questionnaires (65 eyes) were considered complete and analyzed. Two types of implants were identified. Of the 65 eyes analyzed, only 5 eyes (7.7%) did not experience any complication and 60 eyes (92.3%) had at least 1 complication. The most commonly reported complication was corneal decompensation (78.5%). The diagnosis of glaucoma was made in over half (52.3%) of the cases. Explantation was needed in 81.5% of cases. The mean final visual acuity was 0.45 ± 0.08 logarithm of the minimum angle of resolution (logMAR) (0 to 2 logMAR). Conclusions Several ocular complications with a decreased mean visual acuity were described in a young healthy population. In addition, patient information on the safety of this procedure appeared insufficient.

Purpose To report long-term results of Artisan phakic intraocular lens (pIOL) to correct myopia and to propose a model predicting endothelial cell loss after pIOL implantation. Setting Quinze-Vingts National Ophthalmology Hospital, Paris, France. Design Retrospective, interventional case series. Methods Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and central endothelial cell count (ECC) were determined before and at yearly intervals up to 5 years after pIOL implantation. Linear model analysis was performed to present a model that describes endothelial cell loss as a linear decrease and an additional decrease depending on postoperative loss. Results A total of 49 patients (68 eyes) implanted with pIOLs from January 2000 to January 2009 were evaluated. The mean preoperative and final spherical equivalent (SE) were −13 ± 4.10 and −0.75 ± 0.74 diopters (D), respectively. The mean preoperative and final central ECC were 2629 ± 366 and 2250 ± 454 cells/mm 2 , respectively. There were no intraoperative complications for any of the eyes. One eye required surgery for repositioning the pIOL, and 1 eye required pIOL exchange for postoperative refractive error. The model predicted that for patients with preoperative ECC of 3000, 2500, and 2000 cells/mm 2 , a critical ECC of 1500 cells/mm 2 will be reached at 39, 28, and 15 years after implantation, respectively. Conclusions Implantation of the pIOL was an effective and stable procedure after 5 years of follow-up. The presented model predicted EC loss after pIOL implantation, which can assist ophthalmologists in patient selection and follow-up. Financial disclosure The authors report no conflict of interest.