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

NCT04011007 | Completed

• 1 other identifier: 31241
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Holes; Retina Detachment

Outcome Measures

Primary Outcomes (1)

• visual acuity at one year

  12 months

Secondary Outcomes (1)

• rate of retinal attachment and macular hole closure.

  12 months

Study Arms (2)

vitrectomy without ILM peeling

ACTIVE COMPARATOR

vitrectomy without ILM peeling

Procedure: vitrectomy with or without inverted ILM flap technique

vitrectomy with inverted ILM flap technique

ACTIVE COMPARATOR

vitrectomy with inverted ILM flap technique

Procedure: vitrectomy with or without inverted ILM flap technique

Interventions

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.

vitrectomy with inverted ILM flap technique; vitrectomy without ILM peeling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Alexandria university

Alexandria, Egypt

Location

MeSH Terms

Conditions

Retinal Perforations; Retinal Detachment

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 8, 2019
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

EG (1)