Study of Laser Arcuate Incisions Combined With Light Adjustable Lens Implant for Astigmatism Correction in Cataract and Lens Exchange Surgery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of using femtosecond laser arcuate corneal relaxing incisions AK combined with the Light Adjustable Lens LAL implantation to correct pre-existing corneal astigmatism in patients undergoing cataract or refractive lens exchange surgery. The study aims to compare this combined approach to established methods like arcuate keratotomy and toric intraocular lenses, focusing on visual outcomes and patient satisfaction. This is a Phase 4 interventional study sponsored by the Center For Sight. Participants will receive femtosecond laser-assisted arcuate corneal relaxing incisions to address astigmatism, along with implantation of the Light Adjustable Lens during lens removal surgery. The LAL replaces the natural lens, and adjustments to the lens are made postoperatively to achieve the desired refraction. The study includes an 8-week period after the last lens adjustment to evaluate outcomes. The treatment involves precise laser incisions paired in arcs less than 45 mm in length. During the study, participants will undergo scheduled preoperative and follow-up examinations to monitor residual refractive astigmatism, visual performance, and any adverse events. The primary outcome is the number of LAL adjustments required to reach the target refraction 8 weeks after the final adjustment. Secondary outcomes include the percentage of eyes with residual astigmatism of 0.50 diopters or less. Participants must be willing and able to comply with all study procedures and visits throughout the study period.

Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery