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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

March 8, 2011
March 8, 2011
February 2011
August 2011   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Optical coherence tomography findings [ Time Frame: before and after surgery ] [ Designated as safety issue: No ]
schisis pattern and assocaiated macular changes after surgery
Same as current
Not Provided
Not Provided
 
Macular Tractional Retinoschisis in Proliferative Diabetic Retinopathy
Macular Tractional Retinoschisis in Proliferative Diabetic Retinopathy

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

Proliferative Diabetic Retinopathy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
February 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

active vitreous hemorrhage

Both
40 Years to 85 Years
Yes
Contact: Chung-May Yang, MD 886-2-23123456 ext 62131 chungmay@ntu.edu.tw
Taiwan
 
NCT01312207
201101020RC
No
Chung-May Yang, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Study Chair: Chung-May Yang, MD National Taiwan University Hospital
National Taiwan University Hospital
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP