Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
NCT07140653 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-12-22
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
- 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.
Sponsors & Collaborators
-
LensAR Incorporated
collaborator INDUSTRY -
Center For Sight
lead OTHER
Principal Investigators
-
Priya Mathews, MD · Center For Sight - Clinical Studies
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-02
- Primary Completion
- 2026-09-02
- Completion
- 2026-09-02
- FDA Device
- Yes
Countries
- United States
Study Locations
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