Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment (ILMFCMHRDPDR)

August 7, 2018 updated by: San Ni Chen, Changhua Christian Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patient accept surgery
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.
Procedure: ILM flaps insertion techniques or free ILM flaps.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wilcoxon Sign-Rank test
Time Frame: Baseline, 12 months.
A statistical comparison of average of two dependent samples
Baseline, 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Investigators

  • Study Director: Chen San-Ni, MD, Changhua Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 7, 2018

Primary Completion (ACTUAL)

May 31, 2018

Study Completion (ACTUAL)

July 15, 2018

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

August 5, 2018

First Posted (ACTUAL)

August 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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