Flap Sliding to Treat Post-LASIK Striae

August 10, 2019 updated by: Khaled Abdelazeem, Assiut University

Flap Sliding Technique for Managing Flap Striae Following Laser in Situ Keratomileusis

This study assessed the efficacy and safety of a simple, noninvasive "flap sliding" technique for managing flap striae following laser in situ keratomileusis (LASIK). Included eyes underwent flap sliding 1-2 days after surgery, which involved using a cellulose sponge to gently slide the flap perpendicular to the striae. The flap was not lifted during the procedure. Thirteen of 14 eyes were successfully managed with flap sliding. Uncorrected distance visual acuity (DVA) improved in all patients 1 day after flap sliding, with 11 eyes having a corrected DVA of 20/25 or better. Complications following flap sliding occurred in 2 eyes. We believe that our study makes a significant contribution to the literature because it demonstrates a simple, noninvasive technique for managing flap striae that develop during early post-LASIK epithelial healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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

  • Egypt
      • Assiut, Egypt, 71515
        • Alforsan eye center

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

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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
Experimental: Flap Sliding
noninvasive "flap sliding" technique for managing flap striae following laser in situ keratomileusis (LASIK).
Procedure: Flap sliding

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

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2018

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

August 10, 2019

First Submitted That Met QC Criteria

August 10, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 10, 2019

Last Verified

August 1, 2019

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)?

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

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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