Flap Sliding to Treat Post-LASIK Striae

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04055337
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
LASIK Complication Management	Procedure: Flap sliding	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Flap Sliding Technique for Managing Flap Striae Following Laser in Situ Keratomileusis
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Jun 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. UDVA [1 day]

   Uncorrected distance visual acuity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alforsan eye center	Assiut		Egypt	71515

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Khaled Abdelazeem, Associate Professor of Ophthalmology, Assiut University
• ClinicalTrials.gov Identifier: NCT04055337
• Other Study ID Numbers: 17300292
• First Posted: Aug 13, 2019
• Last Update Posted: Aug 13, 2019
• Last Verified: Aug 1, 2019

• 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

Study Results

No Results Posted as of Aug 13, 2019