NCT07140653 · Center For Sight
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
What this study 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.
View original scientific description
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.
Interventions
OTHER
Femto arcs
Femtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism.
DEVICE
Light Adjustable Lens (LAL)
The LAL is intended to replace the natural lens at time of lens removal.
Primary outcome measures
Number of LAL adjustments required to achieve the desired refraction
Time frame: 8 weeks after last lock-in
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Subject who has undergone previous corneal or intraocular surgery in the eye to be treated. 2. Subject with a history, signs or symptoms of ocular disease or atypical findings that would
Where
- Venice, Florida
- Mt. Pleasant, South Carolina
Collaborators
LensAR Incorporated
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 22, 2025 · Source of record for eligibility and locations