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Pupillary Reconstruction and Outcome after Artificial Iris Implantation

Published:February 27, 2016DOI:https://doi.org/10.1016/j.ophtha.2016.01.026

      Purpose

      Patients with iris defects suffer from severe visual impairment, especially increased glare sensitivity and cosmetic disturbances. This constitutes a great psychological strain for those patients. Until recently, possible treatment options were iris print contact lenses, sunglasses, and simple iris prostheses. The aim of this study was to investigate structural and functional outcome parameters and patient satisfaction after implantation of this new artificial iris prosthesis.

      Design

      Prospective case series investigating functional results and patient satisfaction after surgical iris reconstruction.

      Participants

      Thirty-seven consecutive patients with traumatic iris defects presenting from 2011 through 2014 underwent pupillary reconstruction with a new artificial iris implant at the Department of Ophthalmology, Technical University Munich.

      Methods

      The custom-made, flexible silicone iris prosthesis ArtificialIris (HumanOptics, Erlangen, Germany) used in this study is a novel and innovative device in the surgical treatment of iris defects. Patients were examined before and after iris reconstruction with the iris implant placed in the ciliary sulcus.

      Main Outcome Measures

      Change of best-corrected visual acuity (BCVA), intraocular pressure (IOP), pupillary aperture, glare, contrast sensitivity, endothelial cell density, anterior chamber depth, anterior chamber angle, and patient satisfaction were assessed.

      Results

      Thirty-two eyes of 32 patients (mean age, 52.9±16.0 years) were included. After implantation and during follow-up, BCVA and IOP did not change significantly (BCVA, 0.77±0.62 logarithm of the minimum angle of resolution [logMAR] preoperatively vs. 0.68±0.64 logMAR 1 month postoperatively [P = 0.792]; IOP, 14.94±3.55 mmHg preoperatively vs. 17.72±5.88 mmHg 1 month postoperatively [P = 0.197]). The pupillary aperture was reduced significantly (42.11±20.1 mm2 to 8.7±0.3 mm2; P < 0.001). Contrast sensitivity increased significantly (0.80±0.51 to 0.93±0.49; P = 0.014). Endothelial cell count revealed a significant decrease postoperatively (1949±716 per 1 mm2 to 1841±689 per 1 mm2; P = 0.003). Anterior chamber depth (4.03±1.06 mm preoperatively vs. 4.29±0.70 mm postoperatively; P = 0.186) and angle (43.2±13.5° preoperatively vs. 40.5±10.8° postoperatively; P = 0.772) showed no significant differences. Subjective impairment through glare (9.12±1.62 preoperatively vs. 3.07±2.29 postoperatively; P < 0.001) and cosmetic disturbance (6.33±3.21 preoperatively vs. 1.58±0.86 postoperatively; P < 0.001) improved significantly. Patient satisfaction with the overall result was 8.91±1.51 of 10 points on an analog scale.

      Conclusions

      The implantation of the artificial iris is a new and effective therapeutic option for the treatment of distinctive traumatic iris defects and results in an individual, aesthetically appealing, and good functional outcome in addition to high patient satisfaction.

      Abbreviations and Acronyms:

      BCVA (best-corrected visual acuity), CS (contrast sensitivity), IOL (intraocular lens), IOP (intraocular pressure), logMAR (logarithm of the minimum angle of resolution)
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