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Femtosecond 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
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring Astigmatism, Cataract, Femtosecond laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 15, 2020
Last Updated
March 22, 2023
Sponsor
Milton S. Hershey Medical Center
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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

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