Internal Limiting Membrane Flap in the Management of Retinal Detachment Due to Paracentral Retinal Breaks

October 12, 2018 updated by: San Ni Chen
To describe the technique and outcomes of using either inverted or free internal limiting membrane flap in the management of retinal detachment due to paracentral retinal breaks.

Study Overview

Status

Completed

Conditions

Detailed Description

This retrospective observational case series includes nine patients received surgery for retinal detachment due to paracentral retinal breaks developed either from primary rhegmatogenous orgin, or secondary iatrogenic retinal breaks after prior membrane peeling or during surgery for tractional retinal detachment. Either inverted or free internal limiting membrane flaps were inserted in the identified breaks, followed by air fluid exchange and gas tamponade. Visual acuity and structural changes were evaluated.

Study Type

Observational

Enrollment (Actual)

9

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We included patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018. Eyes with macular hole were excluded. All of the cases underwent standard pars plana vitrectomy using the ILM flap technique, accompanied by extended gas tamponade without laser retinopexy

Description

Inclusion Criteria:

  • Patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018

Exclusion Criteria:

  • Patient with macular hole
  • Patient with other ocular diseases including ocular hypertension, optic nerve atrophy, glaucoma or chronic uveitis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
re-attachment rate of retinal detachment
Time Frame: within 3 months postoperatively
re-attachment of retina through examination including fundoscopic exam and optical coherent tomography exam
within 3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity
Time Frame: within 3 months postoperatively
visual acuity in logMAR
within 3 months postoperatively

Collaborators and Investigators

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

Sponsor

San Ni Chen

Investigators

  • Principal Investigator: San-Ni Chen, M.D, Changhua Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2017

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 12, 2018

First Posted (Actual)

October 16, 2018

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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