Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery

NCT07140653 | Recruiting Phase 4 FDA Device

• 1 other identifier: CFS 25-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• Number of LAL adjustments required to achieve the desired refraction

  8 weeks after last lock-in

Secondary Outcomes (1)

• Percentage of eyes with residual refractive astigmatism ≤ 0.50 D

  8 weeks after last lock-in

Study Arms (1)

Femto arcs + LAL

OTHER

Other: Femto arcs; Device: Light Adjustable Lens (LAL)

Interventions

Femto arcs OTHER

Femtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism.

Femto arcs + LAL

Light Adjustable Lens (LAL) DEVICE

The LAL is intended to replace the natural lens at time of lens removal.

Femto arcs + LAL

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject must have central 7 mm of clear cornea without vascularization.

You may not qualify if:

• 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.
• Subject with abnormal corneal topography, including evidence of forme fruste keratoconus, keratoconus or pellucid marginal degeneration.
• Subject with posterior segment disease or degeneration.
• Subject with corneal disease or pathology that precludes an adequate view for imaging or transmission of laser wavelength of light.
• Subject with known sensitivity to planned perioperative standard of care medications.
• Subject participating in any other ophthalmic drug or device clinical trial during the time of this clinical assessment.
• Subject with known sensitivity to planned assessment concomitant medications.
• Subjects with severe dry eye syndrome (DES) or history of ocular inflammation that may impact visual outcomes.

Sponsors & Collaborators

• LensAR Incorporated: collaborator
• Center For Sight: lead

Study Sites (2)

Center For Sight

Venice, Florida, 34285, United States

RECRUITING

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, 29464, United States

RECRUITING

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Priya Mathews, MD

  Center For Sight - Clinical Studies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helga P Sandoval

CONTACT

8438813937; hps@cepmd.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 25, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): September 2, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)