NCT07140653

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

Evaluation of Arcuate Incisions for Correcting Pre-Existing Corneal Astigmatism in Combination With the Light Adjustable Lens for Cataract and Refractive Lens Exchange Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Center For Sight · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and effectiveness of femtosecond laser arcuate corneal relaxing incisions (AK) combined with Light Adjustable Lens (LAL) implantation for correcting pre-existing corneal astigmatism in patients undergoing cataract or refractive lens exchange surgery. Postoperative assessments will focus on residual refractive astigmatism, visual outcomes, patient satisfaction, and the incidence of adverse events. Arcuate keratotomy and toric IOLs are well-established methods for astigmatism correction, and this study will compare their combined effectiveness using advanced femtosecond laser technology.

Conditions

• Astigmatism

Interventions

Type	Name	Description
OTHER	Femto arcs	Femtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism.
DEVICE	Light Adjustable Lens (LAL)	The LAL is intended to replace the natural lens at time of lens removal.

Timeline

• Start date: 2025-09-02
• Primary completion: 2026-09-02
• Completion: 2026-09-02
• First posted: 2025-08-25
• Last updated: 2025-12-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study