Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
NCT ID: NCT07140653
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2025-09-02
2026-09-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Femto arcs + LAL
Femto arcs
Femtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism.
Light Adjustable Lens (LAL)
The LAL is intended to replace the natural lens at time of lens removal.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Femto arcs
Femtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism.
Light Adjustable Lens (LAL)
The LAL is intended to replace the natural lens at time of lens removal.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. 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.
3. Subject with neuro-ophthalmic disease.
4. Diabetic or hypertensive subject with clinical evidence of retinal pathology that the investigator believes will significantly affect visual outcomes.
5. Subject with macular degenerative pathology identified at the preoperative visit that the investigator believes will significantly affect visual outcomes.
6. Subject with a history of steroid-responsive rise in intraocular pressure (IOP), preoperative IOP \>25 mmHg, or uncontrolled glaucoma in either eye.
7. Subject with known lens/zonular instability.
8. Subject who cannot achieve dilated pupillary diameter \> 6 mm.
9. Subject with abnormal corneal topography, including evidence of forme fruste keratoconus, keratoconus or pellucid marginal degeneration.
10. Subject with posterior segment disease or degeneration.
11. Subject with corneal disease or pathology that precludes an adequate view for imaging or transmission of laser wavelength of light.
12. Subject with known sensitivity to planned perioperative standard of care medications.
13. Subject participating in any other ophthalmic drug or device clinical trial during the time of this clinical assessment.
14. Subject with known sensitivity to planned assessment concomitant medications.
15. Subjects with severe dry eye syndrome (DES) or history of ocular inflammation that may impact visual outcomes.
16. Subject with irregular astigmatism in the eye to be treated.
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LensAR Incorporated
INDUSTRY
Center For Sight
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Priya Mathews, MD
Role: PRINCIPAL_INVESTIGATOR
Center For Sight - Clinical Studies
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center For Sight
Venice, Florida, United States
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Gina Thomas
Role: primary
Helga P Sandoval
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CFS 25-003
Identifier Type: -
Identifier Source: org_study_id