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

Part of paid clinical trials in Venice, Florida.

Sponsor
Center For Sight
Study ID
NCT07140653
Phase
PHASE4
Status
Recruiting
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Conditions

  • Astigmatism

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Femto arcs — OTHER
    Femtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism.
  • Light Adjustable Lens (LAL) — DEVICE
    The LAL is intended to replace the natural lens at time of lens removal.

Study Details

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.

Key Dates

Start date
Sep 2, 2025
Status verified
Dec 2025
Primary completion
Sep 2, 2026
Completion
Sep 2, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Femto arcs + LAL

Primary Outcome Measure

Number of LAL adjustments required to achieve the desired refraction [ Time Frame: 8 weeks after last lock-in ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Center For SightVeniceFlorida34285
Gina Thomas
[email protected]
941-263-4784
Carolina Eyecare PhysiciansMt. PleasantSouth Carolina29464
Helga P Sandoval

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