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

• Sponsor: University of Alexandria (Other)
• Overall Status: Completed
• CT.gov ID: NCT04011007
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Holes; Retina Detachment	Procedure: vitrectomy with or without inverted ILM flap technique	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: vitrectomy without ILM peeling 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 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.

Outcome Measures

Primary Outcome Measures

1. visual acuity at one year [12 months]

Secondary Outcome Measures

1. rate of retinal attachment and macular hole closure. [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria university	Alexandria		Egypt

Sponsors and Collaborators

• University of Alexandria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahmoud Abouhussein, Assistant professor, University of Alexandria
• ClinicalTrials.gov Identifier: NCT04011007
• Other Study ID Numbers: 31241
• First Posted: Jul 8, 2019
• Last Update Posted: Jul 8, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Detachment; Retinal Perforations; Dissociative Disorders

Study Results

No Results Posted as of Jul 8, 2019