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

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.

Study Overview

• Status: Completed
• Conditions: Macular Holes; Retina Detachment
• Intervention / Treatment: Procedure: vitrectomy with or without inverted ILM flap technique

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: macular hole retinal detachment in high myopic eyes.

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Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: vitrectomy without ILM peeling	Procedure: vitrectomy with or without inverted ILM flap technique; vitrectomy without ILM peeling versus vitrectomy with inverted ILM flap technique in cases of macular hole retinal detachment in high myopic eyes.
ACTIVE_COMPARATOR: vitrectomy with inverted ILM flap technique	Procedure: vitrectomy with or without inverted ILM flap technique; vitrectomy without ILM peeling versus vitrectomy with inverted ILM flap technique in cases of macular hole retinal detachment in high myopic eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
visual acuity at one year	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
rate of retinal attachment and macular hole closure.	12 months

Collaborators and Investigators

• Sponsor: University of Alexandria

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (ACTUAL): July 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Diseases; Retinal Perforations; Retinal Detachment; Dissociative Disorders
• Other Study ID Numbers: 31241

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No