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

NCT04011007 — Not applicable, Completed, 40 participants, University of Alexandria

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Registry	NCT04011007
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	40 (Actual)
Sponsor	University of Alexandria (Other)
Conditions	Macular Holes, Retina Detachment
Interventions	vitrectomy with or without inverted ILM flap technique (Procedure)
Dates	start 2018-01-01, primary completion 2019-01-01, completion 2019-06-01, first posted 2019-07-08, last updated 2019-07-08
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
vitrectomy without ILM peeling	Active comparator	Procedure: vitrectomy with or without inverted ILM flap technique	vitrectomy without ILM peeling
vitrectomy with inverted ILM flap technique	Active comparator	Procedure: vitrectomy with or without inverted ILM flap technique	vitrectomy with inverted ILM flap technique

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.

+Outcome measures

Primary outcomes

visual acuity at one year [12 months]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Alexandria university	Alexandria	Egypt

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