Cataract Clinical Trial
Official title:
Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism
| NCT number | NCT04676451 |
| Other study ID # | 8058 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 14, 2018 |
| Est. completion date | March 22, 2024 |
| Verified date | May 2024 |
| Source | Milton S. Hershey Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 180 |
| Est. completion date | March 22, 2024 |
| Est. primary completion date | March 22, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Penn State Hershey Eye Center | Hershey | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Milton S. Hershey Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Keratometric Correction Index | 1 month | ||
| Primary | Refractive Correction Index | 1 month |
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