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Macular Tractional Retinoschisis in Proliferative Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT01312207
Recruitment Status : Unknown
Verified January 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 10, 2011
Last Update Posted : March 10, 2011
Information provided by:
National Taiwan University Hospital

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
Proliferative Diabetic Retinopathy

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
Estimated Enrollment : 32 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Macular Tractional Retinoschisis in Proliferative Diabetic Retinopathy
Study Start Date : February 2011
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. visual acuity change after surgery [ Time Frame: before surgery and 3 months after surgery ]
    visual acuity (in logMAR ) before and after surgery

Secondary Outcome Measures :
  1. Optical coherence tomography findings [ Time Frame: before and after surgery ]
    schisis pattern and assocaiated macular changes after surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Inclusion Criteria:

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

Exclusion Criteria:

active vitreous hemorrhage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312207

Contact: Chung-May Yang, MD 886-2-23123456 ext 62131 chungmay@ntu.edu.tw

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chung-May Yang, MD    886-2-23123456 ext 2131    chungmay@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Study Chair: Chung-May Yang, MD National Taiwan University Hospital

Responsible Party: Chung-May Yang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01312207     History of Changes
Other Study ID Numbers: 201101020RC
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: January 2011

Keywords provided by National Taiwan University Hospital:
tractional retinoschisis
traction retinal detachment

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Retinal Degeneration