Ricardo Cuiña Sardiña1, Alexandra Arango, Jose F Alfonso, Juan Álvarez de Toledo, David P Piñero. 1. From the Hospital Clínico San Carlos, Madrid, Spain (Cuiña Sardiña); Hospital Germans Trias i Pujol, Carretera de Canyet, Badalona, Spain (Arango); Instituto Oftalmológico Fernández-Vega, Oviedo, Spain (Alfonso); Centro de Oftalmología Barraquer, Barcelona, Spain (Álvarez de Toledo); Department of Optics, Pharmacology, and Anatomy, University of Alicante, Alicante, Spain (Piñero).
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.
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 patientCDVA.