Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment

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

Completed

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases Retinal Perforations

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhua Christian Hospital

Changhua, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ILM flaps insertion techniques or free ILM flaps.

Procedure

The ILM flap anchoring on the hole edge was inverted and covered the hole.Otherwise, temporal side ILM flap was used. However, if the risk of ILM flipping back was judged to be high, ILM insertion instead of ILM hole coverage was adopted.If the size of the ILM flaps was judged inadequate, the double ILM insertion technique was used, done by adding a piece of previously obtained free ILM flap on top of the inverted ILM tissue until they were securely in place.

Primary outcomes

Wilcoxon Sign-Rank test

Time frame: Baseline, 12 months.

A statistical comparison of average of two dependent samples

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment in Eyes of Proliferative Diabetic Retinopathy

Acronym: ILMFCMHRDPDR

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Aug 7, 2018
Registry last updated: Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed