Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism

Cataract Clinical Trial

Official title:

Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676451
• Other study ID #: 8058
• Status: Completed
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: March 22, 2024

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• Femto-AK
Astigmatic Keratotomy / Arcuate Incisions for the correction of astigmatism

Locations

Country	Name	City	State
United States	Penn State Hershey Eye Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Keratometric Correction Index		1 month
Primary	Refractive Correction Index		1 month