Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery (NCT07140653) | Clinical Trial Compass
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
United States60 participantsStarted 2025-09-02
Plain-language 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
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing arcuate incisions with the Light Adjustable Lens for correcting astigmatism during cataract or lens surgery — is my type and degree of astigmatism a good match for what this study is specifically looking at?
2The trial is measuring how many light adjustment sessions are needed to reach the target prescription with the Light Adjustable Lens — how does that number of post-surgery UV light treatments compare to what I'd experience with a standard toric lens, and how would those extra clinic visits fit into my schedule?
3Since this is a Phase 4 trial, the Light Adjustable Lens is already FDA-approved, but the combination with arcuate incisions is still being studied — what is currently known about the safety and effectiveness of using both techniques together versus each one alone?
4If the arcuate incisions don't fully correct my astigmatism as hoped, how does having the Light Adjustable Lens as a backup option change the risk picture, and is there a scenario where I'd need additional procedures?
5Compared to simply choosing a toric intraocular lens or going with the Light Adjustable Lens on its own, what would you recommend as the most straightforward path for my specific astigmatism, and under what circumstances might enrolling in this trial make sense for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of LAL adjustments required to achieve the desired refraction
. Subject must have central 7 mm of clear cornea without vascularization.
Exclusion criteria
. 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.