Clinical evaluation of the effectiveness of asymmetric intracorneal ring with variable thickness and width for the management of keratoconus

Abstract

Purpose: To evaluate the short-term clinical outcomes obtained with a new model of asymmetric intracorneal ring segments (ICRS) with variable thickness and base width in keratoconus.

Setting: Four ophthalmologic centers in Spain.

Design: Prospective multicenter longitudinal noncomparative clinical trial.

Methods: Thirty-one keratoconus eyes of 25 patients (aged 15 to 50 years) that underwent implantation of ICRS of variable thickness and base (AJL-pro+) in 4 Spanish centers were enrolled. Visual, refractive, topographic, aberrometric, and pachymetric changes were evaluated during a 3-month follow-up. Complications were also recorded.

Results: Statistically significant changes after surgery were observed in uncorrected distance visual acuity (P = .002) and corrected distance visual acuity (CDVA) (P = .005), as well as in spherical equivalent (P = .006). At 3 months postoperatively, no loss of 2 or more lines of CDVA was observed, whereas 48.4% (15) of eyes gained ≥1 line. Statistically significant changes were observed in the steepest and mean keratometric values (P ≤ .047) and in the magnitude of astigmatism (P < .001) of both anterior and posterior corneal surfaces. Likewise, a change to a less prolate shape of the anterior surface was found (P = .011). Primary coma was also reduced significantly at 1 month postoperatively (P = .001, mean reduction 40.1%). No serious implant-related complications occurred during the follow-up.

Conclusions: The implantation of intrastromal asymmetric ring segments of variable thickness and base width in keratoconus corneas induces a significant anterior corneal flattening, leading to refractive changes, a significant reduction of its prolate shape and irregularity, and improvement in patient CDVA.