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OpenTrials
Completed

NCT Number: NCT03292419

Topography-guided LASIK Surgery

The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

About this study

The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior segment optical coherence tomography epithelial thickness maps. The investigators will compare preoperative maps to postoperative maps at one, three, six and twelve months. In addition, the investigators will measure changes in epithelial maps from postoperative month through twelve months to help understand what is happening to the corneal epithelium to try to explain why UDVA and CDVA improves over time

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects age 18 and older with healthy eyes. Nearsightedness between -0.50 diopters and -8.00 diopters.
  • Subjects with up to 3.00 diopters of astigmatism.
  • Subjects with a spherical equivalent of up to -9.00 diopters.

Exclusion criteria

  • Subjects under the age of 18.
  • Subjects with excessively thin corneas.
  • Subjects with topographic evidence of keratoconus.
  • Subjects with ectatic eye disorders.
  • Subjects with autoimmune diseases.
  • Subjects who are pregnant or nursing.
  • Subjects with more than 3.00 diopters of astigmatism

Treatment and study plan

Topography-guided LASIK

Procedure

LASIK surgery

Primary outcomes

  1. Epithelial thickness maps

    Time frame: 12 months

    Changes in anterior segment optical coherence tomography epithelial thickness maps.

Secondary outcomes

  1. Changes in corrected visual acuity

    Time frame: 12 months

    Corrected distance visual acuity (CDVA)

  2. Uncorrected distance visual acuity

    Time frame: 12 months

    Uncorrected distance visual acuity (UDVA)

  3. Quality of Vision

    Time frame: 12 months

    Patient reported outcomes questionnaire

  4. Predictability

    Time frame: 12 months

    Percentage of eyes within +/-0.25, 0.50 and 1.00 diopter of the intended correction

  5. Contrast visual acuity

    Time frame: 12 months

    5 and 25% ETDRS contrast acuity

  6. Residual astigmatism levels after surgery

    Time frame: 12 months

    Vector analysis of astigmatic outcomes

  7. Change in refraction over time

    Time frame: 12 months

    Change in spherical equivalent over time

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Prospective Evaluation of Topography-guided LASIK Surgery

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 25, 2017
Registry last updated
Apr 5, 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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