Back to resultsTopography-guided LASIK Surgery
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Topography-guided LASIK
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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
Sites / Locations
- Byers Eye Institute at Stanford
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Topography guided LASI
Arm Description
Outcomes
Primary Outcome Measures
Epithelial thickness maps
Changes in anterior segment optical coherence tomography epithelial thickness maps.
Secondary Outcome Measures
Changes in corrected visual acuity
Corrected distance visual acuity (CDVA)
Uncorrected distance visual acuity
Uncorrected distance visual acuity (UDVA)
Quality of Vision
Patient reported outcomes questionnaire
Predictability
Percentage of eyes within +/-0.25, 0.50 and 1.00 diopter of the intended correction
Contrast visual acuity
5 and 25% ETDRS contrast acuity
Residual astigmatism levels after surgery
Vector analysis of astigmatic outcomes
Change in refraction over time
Change in spherical equivalent over time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03292419
Brief Title
Topography-guided LASIK Surgery
Official Title
A Prospective Evaluation of Topography-guided LASIK Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Topography guided
Masking
None (Open Label)
Masking Description
N0ne
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topography guided LASI
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Topography-guided LASIK
Intervention Description
LASIK surgery
Primary Outcome Measure Information:
Title
Epithelial thickness maps
Description
Changes in anterior segment optical coherence tomography epithelial thickness maps.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in corrected visual acuity
Description
Corrected distance visual acuity (CDVA)
Time Frame
12 months
Title
Uncorrected distance visual acuity
Description
Uncorrected distance visual acuity (UDVA)
Time Frame
12 months
Title
Quality of Vision
Description
Patient reported outcomes questionnaire
Time Frame
12 months
Title
Predictability
Description
Percentage of eyes within +/-0.25, 0.50 and 1.00 diopter of the intended correction
Time Frame
12 months
Title
Contrast visual acuity
Description
5 and 25% ETDRS contrast acuity
Time Frame
12 months
Title
Residual astigmatism levels after surgery
Description
Vector analysis of astigmatic outcomes
Time Frame
12 months
Title
Change in refraction over time
Description
Change in spherical equivalent over time
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward E Manche, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Byers Eye Institute at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topography-guided LASIK Surgery
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