A prospective, randomized, comparative clinical study to compare the safety and efficacy of different hydrophobic aspheric monofocal intraocular lenses

PURPOSE: To report the 1-year clinical outcomes related to safety, efficacy, predictability, contrast sensitivity, patient satisfaction, complications, and overall results with Optiflex Genesis and Eyecryl Plus (ASHFY 600) monofocal aspheric intraocular lenses (IOLs) and compare the same with Tecnis-1 monofocal IOL. METHODS: This prospective, single-center, single-surgeon, randomized, three-arm study included 159 eyes of 140 eligible patients who underwent cataract extraction with IOL implantation with any of the three study lenses. Clinical outcomes related to safety, efficacy, predictability, contrast sensitivity, patient satisfaction, complications, and overall results were compared at a mean follow-up of 1 year (12 ± 1.20 months). RESULTS: Preoperatively, age and baseline ocular parameters of all the three groups were matched. At 12 months post-op, no significant differences were noted among the groups in terms of mean postoperative uncorrected and corrected distance visual acuity (UDVA and CDVA, respectively) sphere, cylinder, and spherical equivalent (SE; P > 0.05 for all parameters). Eighty-nine percent eyes in the Optiflex Genesis group as against 96% eyes in the Tecnis-1 and Eyecryl Plus (ASHFY 600) groups were within ± 0.5 D, and 100% of eyes in all the three groups were within ± 1.00 D of SE accuracy. Postoperative internal higher-order aberrations (HOAs) and coma, and mesopic contrast sensitivity at all spatial frequencies were comparable across all the three groups. Two eyes in the Tecnis-1 group, two eyes in the Optiflex group, and one eye in the Eyecryl Plus (ASHFY 600) group underwent YAG capsulotomy at the last follow-up. No eye in any of the groups showed glistenings or required IOL exchange due to any reason. CONCLUSION: At 1-year post-op, all the three aspheric lenses showed comparable results in visual and refractive parameters, post-op aberrations, contrast sensitivity, and posterior capsule opacification (PCO) behavior. Further follow-up is needed to evaluate the long-term behavior for refractive stability and PCO rates of these lenses. TRIAL REGISTRY: CTRI/2019/08/020754 (www.ctri.nic.in).