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Sharpening vision: new combo approach for astigmatism in cataract surgery

NCT ID NCT07140653

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether making tiny arcuate incisions on the cornea during cataract surgery, combined with a special light-adjustable lens, can better correct pre-existing astigmatism. About 60 adults will receive this treatment and be followed to see how much their vision improves and how satisfied they are. The goal is to reduce or eliminate the need for glasses after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Carolina Eyecare Physicians

    RECRUITING

    Mt. Pleasant, South Carolina, 29464, United States

  • Center For Sight

    RECRUITING

    Venice, Florida, 34285, United States

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