Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

Not Applicable

Completed

• Conditions: Macular Holes; Retina Detachment
• Interventions: Procedure: vitrectomy with or without inverted ILM flap technique

• Registration Number: NCT04011007
• Lead Sponsor: University of Alexandria

Brief Summary

The aim of this study was to determine whether inverted ILM peeling technique could contribute to high reattachment and closure rates after vitrectomy in patients with myopic macular hole retinal detachment (MHRD) in comparison to no ILM peeling.

This retrospective study will include 40 patients presenting by myopic macular hole retinal detachment. Exclusion criteria will include history of trauma, choroidal neovascularization, and the presence of a peripheral retinal break or proliferative vitreoretinopathy before the initial surgery.

Subjects will be divided into 2 groups; Group 1 will include 20 patients that were treated by vitrectomy without ILM peeling and postoperative gas or silicone oil tamponade with or without cataract surgery.

Group 2 will include 20 patients that were treated by vitrectomy with ILMflap technique and postoperative gas or silicone oil tamponade with or without cataract surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-06-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-04
• Last Update Submitted: 2019-07-04
• Study First Posted: 2019-07-08
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

macular hole retinal detachment in high myopic eyes.

Exclusion Criteria

• eyes with previous vitreoretinal surgery, trauma, diabetic retinopathy, retinal vein occlusion, uveitis, and other retinal diseases were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitrectomy with inverted ILM flap technique	vitrectomy with or without inverted ILM flap technique	vitrectomy with inverted ILM flap technique
vitrectomy without ILM peeling	vitrectomy with or without inverted ILM flap technique	vitrectomy without ILM peeling

Primary Outcome Measures

Name	Time	Method
visual acuity at one year	12 months

Secondary Outcome Measures

Name	Time	Method
rate of retinal attachment and macular hole closure.	12 months

Trial Locations

Locations (1)

Alexandria university; 🇪🇬 Alexandria, Egypt