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Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism

Not Applicable
Completed
Conditions
Astigmatism
Cataract
Interventions
Device: Femto-AK
Registration Number
NCT04676451
Lead Sponsor
Milton S. Hershey Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
94
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Femto-AK PatientsFemto-AKFemtosecond laser assisted cataract surgery with creation of astigmatic keratotomies for the correction of corneal astigmatism.
Primary Outcome Measures
NameTimeMethod
Keratometric Correction Index1 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.

Refractive Correction Index1 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Penn State Hershey Eye Center

🇺🇸

Hershey, Pennsylvania, United States

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