Pupillary Reconstruction and Outcome after Artificial Iris Implantation

Ophthalmology. 2016 May;123(5):1011-8. doi: 10.1016/j.ophtha.2016.01.026. Epub 2016 Feb 28.


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 mm(2) to 8.7±0.3 mm(2); 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 mm(2) to 1841±689 per 1 mm(2); 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.

MeSH terms

  • Artificial Organs*
  • Cell Count
  • Contrast Sensitivity / physiology
  • Endothelium, Corneal / cytology
  • Eye Injuries / surgery*
  • Female
  • Follow-Up Studies
  • Glare
  • Humans
  • Intraocular Pressure / physiology
  • Iris / injuries*
  • Male
  • Middle Aged
  • Ophthalmologic Surgical Procedures*
  • Patient Satisfaction
  • Plastic Surgery Procedures / methods*
  • Prospective Studies
  • Prosthesis Implantation*
  • Pupil*
  • Vision Disorders / rehabilitation
  • Visual Acuity / physiology