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Recruiting NCT07140653

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

Phase IV Interventional Astigmatism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Femto arcs, Light Adjustable Lens (LAL).
Who it may be relevant to
Registry conditions: Astigmatism. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Arcuate Incisions for Correcting Pre-Existing Corneal Astigmatism in Combination With the Light Adjustable Lens for Cataract and Refractive Lens Exchange Surgery

Overview

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.

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]
Secondary outcome measures (1)
  • Percentage of eyes with residual refractive astigmatism ≤ 0.50 D [Time frame: 8 weeks after last lock-in]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Subject with irregular astigmatism in the eye to be treated.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • Center For Sight — Venice
  • Carolina Eyecare Physicians — Mt. Pleasant

Identifiers

NCT: NCT07140653 · CFS 25-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗