Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment

Not Applicable

Completed

• Conditions: Retinal Detachment
• Interventions: Procedure: ILM flaps insertion techniques or free ILM flaps.

• Registration Number: NCT03618498
• Lead Sponsor: Changhua Christian Hospital

Brief Summary

Purpose: To evaluate the logical surgical approaches in closing macular holes in eyes of proliferative diabetic retinopathy with retinal detachment

Detailed Description

High MH closure rate can be achieved. Other than high myopia, MH with RD may appear in several conditions, such as severe vitreomacular traction, proliferative diabetic retinopathy (PDR).clinical charts were reviewed of patients of proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.Standard 3-port 23 or 25 gauged pars plana vitrectomy was performed. After core vitrectomy, anterior-posterior oriented tractions as well as all fibrovascular tissues were removed as thoroughly as possible.The patients were kept in a facedown position overnight and were allowed to take any positions except supine for approximately one week.Various surgical approaches utilizing in managing macular hole may effectively closing macular holes and reattach retina.

Study Timeline

• Study Start: 2018-03-07
• Primary Completion: 2018-05-31
• Study Completion: 2018-07-15
• Study First Submitted: 2018-07-23
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-05
• Study First Posted: 2018-08-07
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients were proliferative diabetic retinopathy suffering from MH with RD.

Exclusion Criteria

• Patients were not proliferative diabetic retinopathy suffering from MH with RD.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Patient accept surgery	ILM flaps insertion techniques or free ILM flaps.	Proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.

Primary Outcome Measures

Name	Time	Method
Wilcoxon Sign-Rank test	Baseline, 12 months.	A statistical comparison of average of two dependent samples

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan