Hydrogel intracorneal inlays for the correction of hyperopia: outcomes and complications after 5 years of follow-up

Abstract

Purpose: To evaluate safety and efficacy of an intracorneal inlay for the correction of hyperopia.

Design: A prospective, nonrandomized, noncomparative, 2-center study.

Participants: Thirty-four hyperopic eyes were implanted with a hydrogel intracorneal inlay (Permavision, Anamed, Lake Forest, CA). Preoperative hyperopia was +3.9 diopter (D; range, +2 to +7). Uncorrected visual acuity (UCVA) was the logarithm of the minimum angle of resolution (logMAR; the decimal logarithm of decimal visual acuity with a minus sign) 0.6 +/- logMAR 1, and best-corrected visual acuity (BCVA) was logMAR 0.1 +/- 0.7.

Methods: Corneal flaps were created with a mechanical microkeratome (M2 [Moria, Anthony, France] or Amadeus [Advanced Medical Optics Inc, Santa Ana, CA]; 180 microm), followed by inlay implantation onto the stromal bed over the pupillary center and covered by the corneal flap. Follow-up was 5 years.

Main outcome measures: We measured UCVA and BCVA; patients underwent, slit-lamp examination, pachymetry, and confocal microscopy. The follow-up was up to 6 years.

Results: The UCVA improved during 3 months and was stable for up to 2 years. There was a loss of > or =2 lines of spectacle-corrected visual acuity in 35% of eyes at 2 years, and a loss of > or =2 lines in 55.5% of the eyes at 5 years. Refractive predictability was poor, with 60% of the eyes having +/-3.00 D of emmetropia. A decentration of the inlay occurred in 29.4%, progressive perilenticular deposits were observed in 88.2%, haze was seen in 73.5%, and the inlay was explanted in 58.8%, with a cumulative survival rate of 58.4%.

Conclusions: An intracorneal inlay may be an option to treat hyperopia, but the tested inlay caused significant visual loss and scarring and had to be explanted in the majority of cases.