- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055337
Flap Sliding to Treat Post-LASIK Striae
Flap Sliding Technique for Managing Flap Striae Following Laser in Situ Keratomileusis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt, 71515
- Alforsan eye center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Significant flap striae in the visual zone within 2 days following microkeratome LASIK.
Exclusion Criteria:
- striae 2 days after surgery
- visually insignificant striae
Study Plan
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 |
---|---|
Experimental: Flap Sliding
noninvasive "flap sliding" technique for managing flap striae following laser in situ keratomileusis (LASIK).
|
All subjects underwent the "flap sliding" technique, which was performed at the Alforsan Eye Centre in Assiut, Egypt. Prior to surgery, all subjects underwent corneal imaging with anterior segment optical coherence tomography to confirm the presence of striae. All surgical procedures were performed by the same surgeon 1 or 2 days following LASIK. Subjects were administered a topical anesthetic. Striae location and orientation were then determined after drying the corneal surface with a cellulose sponge. The sponge was used to push the LASIK flap over the stromal bed in a direction that was perpendicular to the striae. The flap was pushed from the proximal side of the striae toward the flap edge. The ultimate goal was to move striae and put the flap into its proper place. Following surgery, OCT imaging was repeated. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UDVA
Time Frame: 1 day
|
Uncorrected distance visual acuity
|
1 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17300292
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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