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Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04676451
Recruitment Status : Enrolling by invitation
First Posted : December 21, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Seth M Pantanelli, Milton S. Hershey Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Astigmatism Cataract Device: Femto-AK Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Keratometric Correction Index [ Time Frame: 1 month ]
  2. Refractive Correction Index [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676451


Locations
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United States, Pennsylvania
Penn State Hershey Eye Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
More Information
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Responsible Party: Seth M Pantanelli, Associate Professor of Ophthalmology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04676451    
Other Study ID Numbers: 8058
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022

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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
Keywords provided by Seth M Pantanelli, Milton S. Hershey Medical Center:
Astigmatism
Cataract
Femtosecond laser
Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors