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Topography-guided LASIK Surgery

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT03292419
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
46
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Topography-guided LASIK
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Topography guidedTopography guided
Masking:
None (Open Label)
Masking Description:
N0ne
Primary Purpose:
Treatment
Official Title:
A Prospective Evaluation of Topography-guided LASIK Surgery
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Topography guided LASI

Procedure: Topography-guided LASIK
LASIK surgery

Outcome Measures

Primary Outcome Measures

  1. Epithelial thickness maps [12 months]

    Changes in anterior segment optical coherence tomography epithelial thickness maps.

Secondary Outcome Measures

  1. Changes in corrected visual acuity [12 months]

    Corrected distance visual acuity (CDVA)

  2. Uncorrected distance visual acuity [12 months]

    Uncorrected distance visual acuity (UDVA)

  3. Quality of Vision [12 months]

    Patient reported outcomes questionnaire

  4. Predictability [12 months]

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

  5. Contrast visual acuity [12 months]

    5 and 25% ETDRS contrast acuity

  6. Residual astigmatism levels after surgery [12 months]

    Vector analysis of astigmatic outcomes

  7. Change in refraction over time [12 months]

    Change in spherical equivalent over time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Byers Eye Institute at Stanford Palo Alto California United States 94303

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Edward E Manche, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edward E. Manche, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier:
NCT03292419
Other Study ID Numbers:
  • 43306
First Posted:
Sep 25, 2017
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Apr 5, 2022