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Completed

NCT Number: NCT01135719

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

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.

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Key information

Conditions

Hyperopia Astigmatism Eye Diseases Myopia Refractive Errors

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

LASIK and PRK

Procedure

Wavefront-guided versus wavefront-optimized LASIK or PRK.

Other names: Allegretto Wave Eye-Q 400 Hz excimer laser, Visx CustomVue excimer laser, Laser in-situ keratomileusis, Photorefractive keratectomy, Wavefront-guided, Wavefront-optimized

Primary outcomes

  1. Changes in best spectacle corrected visual acuity.

    Time frame: One year

  2. Changes in 25 and 5% low contrast visual acuity.

    Time frame: One year

  3. Improvement in uncorrected visual acuity

    Time frame: One year

Secondary outcomes

  1. Changes in higher order aberrations.

    Time frame: One year

  2. Topographic changes.

    Time frame: One year

  3. Quality of vision changes.

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Edward E. Manche

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2022
First posted
Jun 3, 2010
Registry last updated
Dec 7, 2022

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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