Actively Recruiting
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Led by Center For Sight · Updated on 2025-12-22
60
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Center For Sight
Lead Sponsor
L
LensAR Incorporated
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 vector difference of 0.50 diopters or less measured by Pentacam AXL and Zeiss IOLMaster 700
- Willing and able to comply with study examination procedures
- Astigmatic treatment requiring 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 exams
- 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 contraindicated for lens extraction surgery
- Neuro-ophthalmic disease
- Diabetic or hypertensive with retinal pathology likely to affect visual outcomes
- Macular degenerative pathology likely to affect visual outcomes
- History of steroid-responsive intraocular pressure rise, preoperative IOP greater than 25 mmHg, or uncontrolled glaucoma
- Known lens or zonular instability
- Unable to achieve dilated pupil diameter greater than 6 mm
- Abnormal corneal topography including forme fruste keratoconus, keratoconus, or pellucid marginal degeneration
- Posterior segment disease or degeneration
- Corneal disease or pathology preventing adequate imaging or laser light transmission
- Sensitivity to planned perioperative standard of care medications
- Participation in other ophthalmic drug or device clinical trials during study
- Sensitivity to planned concomitant assessment medications
- Severe dry eye syndrome or history of 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
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
CONTACT
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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