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
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• Subject must be aged ≥ 21 years at the time of eligibility visit.

• Subject must have a vector difference of 0.50 D or less in magnitude of pre-operative anterior corneal astigmatism as measured by the Pentacam AXL and the Zeiss IOLMaster 700 (Carl Zeiss Meditec).

• Subject must be able and willing to comply with the study examination procedures.

• Astigmatic treatment must require paired arcs \<45mm in length.

• Subject must be willing to complete the approved informed consent form.

• Subject must have elected to undergo lens extraction and Light Adjustable Lens (LAL) implantation.

• Subject must be willing and able to return for scheduled pre-op and follow-up examinations.

• Subject must have central 7 mm of clear cornea without vascularization.

Locations
United States
Florida
Center For Sight
RECRUITING
Venice
South Carolina
Carolina Eyecare Physicians
RECRUITING
Mt. Pleasant
Contact Information
Primary
Helga P Sandoval
hps@cepmd.com
8438813937
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2026-09-02
Participants
Target number of participants: 60
Treatments
Other: Femto arcs + LAL
Related Therapeutic Areas
Sponsors
Collaborators: LensAR Incorporated
Leads: Center For Sight

This content was sourced from clinicaltrials.gov