Back to resultsThe Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia
Primary Purpose
Incidence and Severity of Dry Eye After Myopic LASIK
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LASIK
Sponsored by
About this trial
This is an interventional diagnostic trial for Incidence and Severity of Dry Eye After Myopic LASIK
Eligibility Criteria
Inclusion Criteria:
- Patients with age ≥ 21 years
- Normal Pentacam maps
- Myopia with spherical equation less than 12 D
- Corneal thickness ≥ 500 Microns
- Calculated residual stromal bed ≥ 280 microns
- No signs or symptoms of dry eye.
Exclusion Criteria :
- Keratoconus and forme fruste keratoconus
- Auto-immune diseases
- History of dry eye or previous use of tear substitutes
- Previous ocular surgery
- Pregnant or lactating women.
Sites / Locations
Outcomes
Primary Outcome Measures
Incidence of dry eye
Schirmer 1 test in millimeters
Degree of dryness
Tear break up time in seconds
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03228784
Brief Title
The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia
Official Title
The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2013 (Actual)
Primary Completion Date
May 1, 2014 (Actual)
Study Completion Date
May 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
5. Study Description
Brief Summary
The study tried to find the relation between ablation depth and degree of dryness after LASIK treatment of myopic patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incidence and Severity of Dry Eye After Myopic LASIK
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
LASIK
Other Intervention Name(s)
Corneal Flap creation with mechanical microkeratome and stromal ablation with Excimerr laser.
Primary Outcome Measure Information:
Title
Incidence of dry eye
Description
Schirmer 1 test in millimeters
Time Frame
6 months
Title
Degree of dryness
Description
Tear break up time in seconds
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Eligibility Criteria
Inclusion Criteria:
Patients with age ≥ 21 years
Normal Pentacam maps
Myopia with spherical equation less than 12 D
Corneal thickness ≥ 500 Microns
Calculated residual stromal bed ≥ 280 microns
No signs or symptoms of dry eye.
Exclusion Criteria :
Keratoconus and forme fruste keratoconus
Auto-immune diseases
History of dry eye or previous use of tear substitutes
Previous ocular surgery
Pregnant or lactating women.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia
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