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OpenTrials
Completed

NCT Number: NCT04676451

Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism

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.

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Key information

Conditions

Astigmatism Cataract Eye Diseases Lens Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Eye Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femto-AK

Device

Astigmatic Keratotomy / Arcuate Incisions for the correction of astigmatism

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2020
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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