Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism

NCT04676451 | Completed Results FDA Device

• 1 other identifier: 8058
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism; Cataract

Keywords

Astigmatism; Cataract; Femtosecond laser

Outcome Measures

Primary Outcomes (2)

• Keratometric Correction Index

  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

  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

Study Arms (1)

Femto-AK Patients

EXPERIMENTAL

Femtosecond laser assisted cataract surgery with creation of astigmatic keratotomies for the correction of corneal astigmatism.

Device: Femto-AK

Interventions

Femto-AK DEVICE

Astigmatic Keratotomy / Arcuate Incisions for the correction of astigmatism

Femto-AK Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with corneal dystrophies, including anterior basement membrane dystrophy, keratoconus, and Fuch's endothelial corneal dystrophy.
• Age \< 18 years
• Pregnant women
• Cognitive impairment
• Prisoners

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Eye Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Astigmatism; Cataract

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lens Diseases

Results Point of Contact

• Title: Amy Longenecker
• Organization: Penn State Hershey Medical Center

alongenecker@pennstatehealth.psu.edu

717-531-1513

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Model Details: This is a prospective, single-center, single-arm, interventional clinical trial. Subjects that meet inclusion and exclusion criteria are invited to participate.

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: May 14, 2018
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-04

Locations

US (1)