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Macular Tractional Retinoschisis in Proliferative Diabetic Retinopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01312207
First received: March 8, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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
Proliferative Diabetic Retinopathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Macular Tractional Retinoschisis in Proliferative Diabetic Retinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • visual acuity change after surgery [ Time Frame: before surgery and 3 months after surgery ] [ Designated as safety issue: No ]
    visual acuity (in logMAR ) before and after surgery


Secondary Outcome Measures:
  • Optical coherence tomography findings [ Time Frame: before and after surgery ] [ Designated as safety issue: No ]
    schisis pattern and assocaiated macular changes after surgery


Estimated Enrollment: 32
Study Start Date: February 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

active vitreous hemorrhage

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312207

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

Locations
Taiwan
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
Investigators
Study Chair: Chung-May Yang, MD National Taiwan University Hospital
  More Information

Publications:

Responsible Party: Chung-May Yang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01312207     History of Changes
Other Study ID Numbers: 201101020RC
Study First Received: March 8, 2011
Last Updated: March 8, 2011
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on May 19, 2013