Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
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
| Condition(s) | Astigmatism |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Subject must be aged ≥ 21 years at the time of eligibility visit. 2. 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). 3. Subject must be able and willing to comply with the study examination procedures. 4. Astigmatic treatment must require paired arcs \<45mm in length. 5. Subject must be willing to complete the approved informed consent form. 6. Subject must have elected to undergo lens extraction and Light Adjustable Lens (LAL) implantation. 7. Subject must be willing and able to return for scheduled pre-op and follow-up examinations. 8. Subject must have central 7 mm of clear cornea without vascularization. Exclusion Cr |
| Ages | 21 Years |
| Sex | All |
| Lead sponsor | Center For Sight |
| Locations | Venice, Florida, United States; Mt. Pleasant, South Carolina, United States |
| Start date | 2025-09-02 |
| NCT ID | NCT07140653 |
| Official listing | https://clinicaltrials.gov/study/NCT07140653 |