Femtosecond arcuate corneal incisions combined with a Light Adjustable Lens for correcting astigmatism during lens surgery

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

This will try whether precise femtosecond arcuate corneal incisions plus a Light Adjustable Lens can reduce astigmatism and improve vision for adults having cataract or refractive lens exchange.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Center For Sight (Academic / other)
• Locations: 2 sites (Venice, Florida and 1 other locations)
• Trial ID: NCT07140653 on ClinicalTrials.gov

What this trial studies

Adults undergoing cataract extraction or refractive lens exchange will receive femtosecond laser–created paired arcuate corneal incisions at the time of implantation of a Light Adjustable Lens (LAL). Postoperative care includes LAL light treatments as indicated and scheduled follow-up visits to measure residual refractive astigmatism, visual acuity, patient satisfaction, and adverse events. The protocol uses automated corneal measurements (Pentacam AXL and IOLMaster 700) for eligibility and planning, and outcomes will be compared with established astigmatism-correction approaches. The study focuses on safety and refractive accuracy when combining modern femtosecond arcuate incisions with the adjustable optics of the LAL.

Who should consider this trial

Good fit: Adults aged 21 or older planning lens extraction with Light Adjustable Lens implantation who have a clear central 7 mm cornea and consistent preoperative corneal measurements compatible with paired arcuate incisions.

Not a fit: People with prior corneal or intraocular surgery, active or atypical ocular disease, or corneas that do not meet the measurement or clarity requirements are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the combination could give more precise correction of corneal astigmatism and better uncorrected vision after lens surgery.

How similar studies have performed: Arcuate keratotomy and toric intraocular lenses are well-established for astigmatism and the Light Adjustable Lens has shown effectiveness for postoperative tuning, but combining femtosecond arcuate incisions with LAL is less extensively studied.

Eligibility criteria

Inclusion Criteria:

1. 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:

1. 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 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.

Where this trial is running

Venice, Florida and 1 other locations

• Center For Sight — Venice, Florida, United States (Recruiting)
• Carolina Eyecare Physicians — Mt. Pleasant, South Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Priya Mathews, MD — Center For Sight - Clinical Studies
• Study coordinator: Helga P Sandoval

Conditions Astigmatism