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

Macular Holes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011007
• Other study ID #: 31241
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2019
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dissociative Disorders
• Macular Holes
• Retina Detachment
• Retinal Detachment
• Retinal Perforations

Intervention

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.

Locations

Country	Name	City	State
Egypt	Alexandria university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity at one year		12 months
Secondary	rate of retinal attachment and macular hole closure.		12 months