Actively Recruiting
Evaluation of Arcuate Incisions for Correcting Pre-Existing Corneal Astigmatism in Combination With the Light Adjustable Lens for Cataract and Refractive Lens Exchange Surgery
Led by Center For Sight · Updated on 2025-12-22
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Center For Sight
Lead Sponsor
L
LensAR Incorporated
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of using femtosecond laser arcuate corneal relaxing incisions (AK) combined with the Light Adjustable Lens (LAL) implantation to correct pre-existing corneal astigmatism in patients undergoing cataract or refractive lens exchange surgery. The study aims to compare this combined approach to established methods like arcuate keratotomy and toric intraocular lenses, focusing on visual outcomes and patient satisfaction. This is a Phase 4 interventional study sponsored by the Center For Sight. Participants will receive femtosecond laser-assisted arcuate corneal relaxing incisions to address astigmatism, along with implantation of the Light Adjustable Lens during lens removal surgery. The LAL replaces the natural lens, and adjustments to the lens are made postoperatively to achieve the desired refraction. The study includes an 8-week period after the last lens adjustment to evaluate outcomes. The treatment involves precise laser incisions paired in arcs less than 45 mm in length. During the study, participants will undergo scheduled preoperative and follow-up examinations to monitor residual refractive astigmatism, visual performance, and any adverse events. The primary outcome is the number of LAL adjustments required to reach the target refraction 8 weeks after the final adjustment. Secondary outcomes include the percentage of eyes with residual astigmatism of 0.50 diopters or less. Participants must be willing and able to comply with all study procedures and visits throughout the study period.
CONDITIONS
Brief Title
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older at the time of eligibility visit
- Pre-operative anterior corneal astigmatism with vector difference of 0.50 diopters or less as measured by Pentacam AXL and Zeiss IOLMaster 700
- Able and willing to comply with study examination procedures
- Astigmatic treatment requires paired arcs less than 45 mm in length
- Willing to complete the approved informed consent form
- Elected to undergo lens extraction and Light Adjustable Lens implantation
- Willing and able to return for scheduled preoperative and follow-up examinations
- Central 7 mm of clear cornea without vascularization
You will not qualify if you...
- Previous corneal or intraocular surgery in the eye to be treated
- History, signs, or symptoms of ocular disease or atypical findings contraindicating lens extraction surgery
- Neuro-ophthalmic disease
- Diabetic or hypertensive with retinal pathology affecting visual outcomes
- Macular degenerative pathology affecting visual outcomes
- History of steroid-responsive intraocular pressure rise, preoperative IOP over 25 mmHg, or uncontrolled glaucoma
- Known lens or zonular instability
- Unable to achieve dilated pupillary diameter over 6 mm
- Abnormal corneal topography including keratoconus or pellucid marginal degeneration
- Posterior segment disease or degeneration
- Corneal disease or pathology preventing adequate imaging or laser transmission
- Known sensitivity to planned perioperative medications
- Participation in other ophthalmic drug or device clinical trials during this assessment
- Known sensitivity to assessment concomitant medications
- Severe dry eye syndrome or ocular inflammation impacting visual outcomes
- Irregular astigmatism in the eye to be treated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo lens extraction surgery with femtosecond laser-assisted arcuate corneal relaxing incisions and implantation of the Light Adjustable Lens.
1 surgery visit and immediate post-operative visits
Duration - Up to 8 weeks after last lock-in
Participants receive Light Adjustable Lens adjustments to achieve the desired refraction.
Multiple adjustment visits over approximately 8 weeks
Duration - 8 weeks after last lens lock-in
Participants are monitored for residual refractive astigmatism and visual outcomes after the last lens adjustment.
Regular follow-up visits during this period
Trial Site Locations
Total: 2 locations
1
Center For Sight
Venice, Florida, United States, 34285
Actively Recruiting
2
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
Research Team
H
Helga P Sandoval
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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