- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01312207
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.
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
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Contact:
- Chung-May Yang, MD
- Phone Number: 2131 886-2-23123456
- Email: chungmay@ntu.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
tractional retinoschisis without TRD in PDR tractional retinoschisis with TRD in PDR
Exclusion Criteria:
active vitreous hemorrhage
Study Plan
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
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visual acuity (in logMAR ) before and after surgery
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before surgery and 3 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optical coherence tomography findings
Time Frame: before and after surgery
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schisis pattern and assocaiated macular changes after surgery
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before and after surgery
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Collaborators and Investigators
Investigators
- Study Chair: Chung-May Yang, MD, National Taiwan University Hospital
Publications and helpful links
General Publications
- Imai M, Iijima H, Hanada N. Optical coherence tomography of tractional macular elevations in eyes with proliferative diabetic retinopathy. Am J Ophthalmol. 2001 Sep;132(3):458-61. doi: 10.1016/s0002-9394(01)01176-x.
- Faulborn J, Ardjomand N. Tractional retinoschisis in proliferative diabetic retinopathy: a histopathological study. Graefes Arch Clin Exp Ophthalmol. 2000 Jan;238(1):40-4. doi: 10.1007/s004170050007.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201101020RC
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