Macular Tractional Retinoschisis in Proliferative Diabetic Retinopathy

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01312207
Collaborator
(none)
32
1
12
2.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    32 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Macular Tractional Retinoschisis in Proliferative Diabetic Retinopathy
    Study Start Date :
    Feb 1, 2011
    Anticipated Primary Completion Date :
    Aug 1, 2011
    Anticipated Study Completion Date :
    Feb 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. visual acuity change after surgery [before surgery and 3 months after surgery]

      visual acuity (in logMAR ) before and after surgery

    Secondary Outcome Measures

    1. Optical coherence tomography findings [before and after surgery]

      schisis pattern and assocaiated macular changes after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

    Exclusion Criteria:

    active vitreous hemorrhage

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01312207
    Other Study ID Numbers:
    • 201101020RC
    First Posted:
    Mar 10, 2011
    Last Update Posted:
    Mar 10, 2011
    Last Verified:
    Jan 1, 2011

    Study Results

    No Results Posted as of Mar 10, 2011