Flap Sliding to Treat Post-LASIK Striae

NCT ID: NCT04055337

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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LASIK Complication Management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flap Sliding

noninvasive "flap sliding" technique for managing flap striae following laser in situ keratomileusis (LASIK).

Group Type EXPERIMENTAL

Flap sliding

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Khaled Abdelazeem

Associate Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alforsan eye center

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Abdelazeem K, Nassr MA, Abdelmotaal H, Wasfi E, El-Sebaity DM. Flap Sliding Technique for Managing Flap Striae following Laser In Situ Keratomileusis. J Ophthalmol. 2020 Feb 24;2020:5614327. doi: 10.1155/2020/5614327. eCollection 2020.

Reference Type DERIVED
PMID: 32185074 (View on PubMed)

Other Identifiers

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17300292

Identifier Type: -

Identifier Source: org_study_id

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