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A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01135719
Enrollment
137
Registered
2010-06-03
Start date
2009-04-30
Completion date
2022-12-03
Last updated
2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Hyperopia, Myopia

Keywords

Myopia, Hyperopia, Astigmatism, PRK, LASIK

Brief summary

Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

Detailed description

Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.

Interventions

PROCEDURELASIK and PRK

Wavefront-guided versus wavefront-optimized LASIK or PRK.

Sponsors

Edward E. Manche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects age 21 and older. * Subjects with nearsightedness, farsightedness and/or astigmatism.

Exclusion criteria

Autoimmune diseases. * Children. * Women pregnant or nursing. * Ectatic corneal disease. * Previous ocular surgery.

Design outcomes

Primary

MeasureTime frame
Changes in best spectacle corrected visual acuity.One year
Changes in 25 and 5% low contrast visual acuity.One year
Improvement in uncorrected visual acuityOne year

Secondary

MeasureTime frame
Changes in higher order aberrations.One year
Topographic changes.One year
Quality of vision changes.One year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026