Topography-guided LASIK Surgery

April 3, 2022 updated by: Edward E. Manche, Stanford University

A Prospective Evaluation of Topography-guided LASIK Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute at Stanford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Topography guided LASI
Procedure: Topography-guided LASIK
LASIK surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epithelial thickness maps
Time Frame: 12 months
Changes in anterior segment optical coherence tomography epithelial thickness maps.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in corrected visual acuity
Time Frame: 12 months
Corrected distance visual acuity (CDVA)
12 months
Uncorrected distance visual acuity
Time Frame: 12 months
Uncorrected distance visual acuity (UDVA)
12 months
Quality of Vision
Time Frame: 12 months
Patient reported outcomes questionnaire
12 months
Predictability
Time Frame: 12 months
Percentage of eyes within +/-0.25, 0.50 and 1.00 diopter of the intended correction
12 months
Contrast visual acuity
Time Frame: 12 months
5 and 25% ETDRS contrast acuity
12 months
Residual astigmatism levels after surgery
Time Frame: 12 months
Vector analysis of astigmatic outcomes
12 months
Change in refraction over time
Time Frame: 12 months
Change in spherical equivalent over time
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 20, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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