Sharpening vision: new combo approach for astigmatism in cataract surgery
NCT ID NCT07140653
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Carolina Eyecare Physicians
RECRUITINGMt. Pleasant, South Carolina, 29464, United States
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Center For Sight
RECRUITINGVenice, Florida, 34285, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A lens that could let cataract patients see near and far without glasses
- Two toric lenses go head to head in vision test
- One operation for cataract and glaucoma? eye surgeons test a Two-in-One approach
- Eye drops may shield the cornea after cataract surgery
- Can glasses that slow nearsightedness also reshape a Child's astigmatism?
- Can newer cataract lenses keep vision clear for years?