Back to resultsFemtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism
Primary Purpose
Astigmatism, Cataract
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Femto-AK
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism focused on measuring Astigmatism, Cataract, Femtosecond laser
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
Sites / Locations
- Penn State Hershey Eye Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Femto-AK Patients
Arm Description
Femtosecond laser assisted cataract surgery with creation of astigmatic keratotomies for the correction of corneal astigmatism.
Outcomes
Primary Outcome Measures
Keratometric Correction Index
Refractive Correction Index
Secondary Outcome Measures
Full Information
NCT ID
NCT04676451
First Posted
December 15, 2020
Last Updated
March 22, 2023
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04676451
Brief Title
Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism
Official Title
Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism, Cataract
Keywords
Astigmatism, Cataract, Femtosecond laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, single-center, single-arm, interventional clinical trial. Subjects that meet inclusion and exclusion criteria are invited to participate.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Femto-AK Patients
Arm Type
Experimental
Arm Description
Femtosecond laser assisted cataract surgery with creation of astigmatic keratotomies for the correction of corneal astigmatism.
Intervention Type
Device
Intervention Name(s)
Femto-AK
Intervention Description
Astigmatic Keratotomy / Arcuate Incisions for the correction of astigmatism
Primary Outcome Measure Information:
Title
Keratometric Correction Index
Time Frame
1 month
Title
Refractive Correction Index
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Penn State Hershey Eye Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism
We'll reach out to this number within 24 hrs