Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in 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

Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery (NCT07140653) is a Phase 4 interventional studying Astigmatism, sponsored by Center For Sight. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Astigmatism subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Center For Sight

Venice, Florida, United States

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07140653), the sponsor (Center For Sight), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07140653 clinical trial studying?

Who can participate in NCT07140653?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07140653?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07140653. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07140653. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.