Status:
RECRUITING
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Lead Sponsor:
Center For Sight
Collaborating Sponsors:
LensAR Incorporated
Conditions:
Astigmatism
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Subject who has undergone previous corneal or intraocular surgery in the eye to be treated.
- Subject with a history, signs or symptoms of ocular disease or atypical findings that would be contraindicated under standard of care for lens extraction surgery.
- Subject with neuro-ophthalmic disease.
- Diabetic or hypertensive subject with clinical evidence of retinal pathology that the investigator believes will significantly affect visual outcomes.
- Subject with macular degenerative pathology identified at the preoperative visit that the investigator believes will significantly affect visual outcomes.
- Subject with a history of steroid-responsive rise in intraocular pressure (IOP), preoperative IOP \>25 mmHg, or uncontrolled glaucoma in either eye.
- Subject with known lens/zonular instability.
- Subject who cannot achieve dilated pupillary diameter \> 6 mm.
- Subject with abnormal corneal topography, including evidence of forme fruste keratoconus, keratoconus or pellucid marginal degeneration.
- Subject with posterior segment disease or degeneration.
- Subject with corneal disease or pathology that precludes an adequate view for imaging or transmission of laser wavelength of light.
- Subject with known sensitivity to planned perioperative standard of care medications.
- Subject participating in any other ophthalmic drug or device clinical trial during the time of this clinical assessment.
- Subject with known sensitivity to planned assessment concomitant medications.
- Subjects with severe dry eye syndrome (DES) or history of ocular inflammation that may impact visual outcomes.
- Subject with irregular astigmatism in the eye to be treated.
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 2 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07140653
Start Date
September 2 2025
End Date
September 2 2026
Last Update
December 22 2025
Active Locations (2)
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1
Center For Sight
Venice, Florida, United States, 34285
2
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, United States, 29464