Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism

April 29, 2025 updated by: Seth M Pantanelli, Milton S. Hershey Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Femto-AK Patients
Femtosecond laser assisted cataract surgery with creation of astigmatic keratotomies for the correction of corneal astigmatism.
Device: Femto-AK
Astigmatic Keratotomy / Arcuate Incisions for the correction of astigmatism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratometric Correction Index
Time Frame: 1 month
Keratometric Correction index is the ratio of surgically induced astigmatism to target induced astigmatism. A correction index of 1 suggests that the actual surgically induced astigmatism, as measured by pre- vs- post-op reflectance keratometry, perfectly matched the target (anticipated) induced astigmatism. Correction indices below 1 suggest an under-correction while values above 1 suggest an over-correction.
1 month
Refractive Correction Index
Time Frame: 1 month
Refractive Correction index is the ratio of surgically induced astigmatism to net effective astigmatism. A correction index of 1 suggests that the actual surgically induced astigmatism, as measured by pre- vs- post-op manifest refraction, perfectly matched the effective astigmatism as estimated by the nomogram. Correction indices below 1 suggest an under-correction while values above 1 suggest an over-correction.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2018

Primary Completion (Actual)

March 22, 2024

Study Completion (Actual)

March 22, 2024

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8058

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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