Macular Tractional Retinoschisis in Proliferative Diabetic Retinopathy

March 8, 2011 updated by: National Taiwan University Hospital

Objective: To evaluate the clinical manifestations and surgical prognosis of macular tractional retinoschisis in proliferative diabetic retinopathy.

Design: Retrospective case series. Participants: Cases with macular tractional retinoschisis with or without combined traction detachment (TRD) in proliferative diabetic retinopathy confirmed by optical coherence tomography (OCT) at a single institution between January 2007 and August 2010.

Methods: Cases were divided into two groups. Group A had tractional retinoschisis only while Group B had TRD with retinoschisis of the elevated retina. Clinical data including OCT findings were recorded and analyzed.

Main Outcome Measures: Demographic data, clinical pictures, surgical results, and OCT findings will be compared between two the groups.

Study Overview

Status

Unknown

Detailed Description

Fibrovascular tissue induced macular elevation is an important cause of visual loss in proliferative diabetic retinopathy (PDR). There are two main types of macular elevations in PDR: traction retinal detachment (TRD) and tractional retinoschisis. These two conditions may coexist either in the form of retinoschisis within the detached retina or predominantly retinoschisis with a small subfoveal fluid pocket. Optical coherence tomography (OCT) studies have shown that in tractional retinoschisis, the inner retinal layer is normal reflective; outer layer is less reflective but not optically empty. Bridging columnar tissues are frequently observed between the inner and outer layers. Histopathological study by Faulborn et al showed adherence of posterior hyaloid membrane to the retina plus vitreous body shrinkage might induce retinal elevation with splitting of the outer plexiform layer, leading to retinoschisis. The bridging columnar tissues between inner and outer layers of the split retina mainly consisted of Muller cells. Although tractional retinoschisis with or without retinal detachment has been suggested as the most frequent pattern of tractional macular elevation in eyes with proliferative diabetic retinopathy1, and peripheral retinoschisis are frequently found during operation for complications of PDR, studies on clinical manifestations and post-operative visual prognosis of macular traction schisis are limited. Lincoff reported a relatively good prognosis in eyes with tractional retinoschisis after vitrectomy. No other large series specifically aimed at this entity can be found.

In this report, we will retrospectively study the clinical pictures of tractional retinoschisis on the macula. Morphological changes and functional outcomes after surgery will be discussed. Correlations between visual acuity and specific findings on color fundus pictures and OCT will be evaluated. We will also analyze different behaviors of schisis only and combined tractional retinal detachment with schisis.

Study Type

Observational

Enrollment (Anticipated)

32

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

      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cases with macular tractional retinoschisis with or without combined traction detachment (TRD) in proliferative diabetic retinopathy confirmed by optical coherence tomography

Description

Inclusion Criteria:

tractional retinoschisis without TRD in PDR tractional retinoschisis with TRD in PDR

Exclusion Criteria:

active vitreous hemorrhage

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
visual acuity change after surgery
Time Frame: before surgery and 3 months after surgery
visual acuity (in logMAR ) before and after surgery
before surgery and 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optical coherence tomography findings
Time Frame: before and after surgery
schisis pattern and assocaiated macular changes after surgery
before and after surgery

Collaborators and Investigators

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

Investigators

  • Study Chair: Chung-May Yang, MD, National Taiwan University 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.

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

February 1, 2011

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

March 10, 2011

Last Update Submitted That Met QC Criteria

March 8, 2011

Last Verified

January 1, 2011

More Information

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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