N/A
N=94
Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism
Astigmatism · Cataract
Bottom Line
View on ClinicalTrials.gov: NCT04676451 ↗Enrolled (actual)
94
Serious AEs
—
Results posted
May 2025
Primary outcome: Primary: Keratometric Correction Index — 0.51 index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Femto-AK (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Keratometric Correction Index |
0.51 | — |
| PRIMARY Refractive Correction Index |
0.91 | — |
Summary
A cataract is a clouding of the lens that occurs naturally with age. Cataract surgery involves removal of the cloudy lens and replacement with an artificial one. A special laser (femtosecond laser) is now being used to help make cataract surgery safer and more accurate . The femtosecond laser can also be used to correct astigmatism, an irregular curvature of the cornea, at the time of cataract surgery through a procedure called astigmatic keratotomy (AK). This study is gathering information about the specific laser settings that are used to perform astigmatic keratotomies (AK) during cataract surgery. This information will be used to improve the outcomes of patients that receive cataract surgery with astigmatic keratotomies in the future.
Eligibility Criteria
Inclusion Criteria
- Age: ≥18 years of age
- Sex: male or female
- Patients who are planned to undergo femtosecond laser-assisted cataract surgery with astigmatic keratotomy at the Schein Ernst Mishra Eye clinic within the next 60 days of their cataract consultation visit. Subjects with planned single or bilateral cataract eye surgeries are eligible. Planned opposite eye surgery must be within 2-4 weeks of first cataract surgery.
- Fluent in written and spoken English
Exclusion Criteria
- Patients with corneal dystrophies, including anterior basement membrane dystrophy, keratoconus, and Fuch's endothelial corneal dystrophy.
- Age < 18 years
- Pregnant women
- Cognitive impairment
- Prisoners
Data sourced from ClinicalTrials.gov (NCT04676451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.