Abstract
Purpose: To assess the safety and efficacy of the implantable contact lens (ICL (TM)) to treat myopia.
Design: Clinical, retrospective, single center, non-randomized case series.
Participants: Sixty-nine eyes of 46 patients with myopia ranging from 3.00 to 25.00 D were included in this study.
Intervention: Implantation of the ICL (TM).
Main outcome measures: Uncorrected Visual Acuity (UCVA), refraction, best spectacle corrected visual acuity (BSCVA), adverse events, operative and postoperative complications, subjective assessment and symptoms.
Results: The mean follow-up was 12.35 +/- 6.13 (SD) months (range, 6 months-32 months). At the last visit, 49.20% of eyes had 20/ 20 or better UCVA compared to preoperative 20/20 or better BSCVA of 31.9% of eyes; 69.23% of eyes had postoperative UCVA better than or equal to preoperative BSCVA. The mean manifest refractive cylinder was 1.93 +/- 1.21 D at baseline and 1.00 +/- 0.92 D postoperatively. The mean manifest refraction spherical equivalent (MRSE) was -11.70 +/- 4.24 D preoperatively and -0.69 +/- 1.13 D postoperatively. A total of 69.8% of eyes were within +/-0.5 D of the predicted MRSE; 84.1% were within +/- 1.0 D, and 88.90% were within +/-2.0 D. BSCVA of 20/20 or better was achieved in 64.6% of eyes postoperatively, compared to 31.9% preoperatively. Mean improvement in BSCVA was 1line. One eye (1.5%) lost >= 2 lines of BSCVA at the last visit, whereas 20% of eyes improved by >= 2 lines. A total of 56.92% of cases gained >= 1 line of BSCVA and 4.62% of cases lost >= 1 line. Four ICL lenses were removed without significant loss of BSCVA, and 2 eyes with clinically significant lens opacities were observed. Four eyes (5.8%) developed a pupillary block the first day postoperatively. One eye (1.4%) developed a hypotony and AC shallowing.
Conclusion: Implantation of ICL for the correction of myopia was a safe procedure with good visual and refractive results from the early postoperative period to 1 year. Long-term follow-up is required to confirm the long-term safety of this implant.