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OpenTrials
Completed

NCT Number: NCT04011007

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria university

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vitrectomy with or without inverted ILM flap technique

Procedure

vitrectomy without ILM peeling versus vitrectomy with inverted ILM flap technique in cases of macular hole retinal detachment in high myopic eyes.

Primary outcomes

  1. visual acuity at one year

    Time frame: 12 months

Secondary outcomes

  1. rate of retinal attachment and macular hole closure.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2019
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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