Pars Plana Vitrectomy for Diabetic Fibrovascular Proliferation With and Without Internal Limiting Membrane Peeling
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patients With Proliferative Diabetic Retinopathy Who Have Active Fibrovascular Proliferation
Intervention: ILM peeling (Procedure)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s):
Chung-may Yang, M.D., Principal Investigator, Affiliation: National Taiwan University Hospital
Chung-may Yang, M.D., Principal Investigator, Affiliation: National Taiwan University Hospital
Overall contact:
Pei-yao Chang, M.D., Phone: 886-2-23123456, Ext: 5187, Email: peiyao@seed.net.tw
Summary
Internal limiting membrane peeling in diabetic vitrectomy will help prevent postoperative
epiretinal membrane formation
Clinical Details
Official title: Pars Plana Vitrectomy for Diabetic Fibrovascular Proliferation With and Without Internal Limiting Membrane Peeling
Study design: Treatment, Non-Randomized, Single Blind (Investigator), Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Snellen BCVA and epiretinal membrane formation measured with OCT
Secondary outcome: central macular thickness measured bt OCT
Detailed description:
Progressive fibrovascular proliferation may occur despite appropriate panretinal
photocoagulation in diabetic patients. Fibrovascular proliferation may lead to persistent or
recurrent vitreous hemorrhage, macular traction, or traction macular detachment, and becomes
a major indication for vitrectomy. 1 During the past 25 years, anatomical and visual results
of vitrectomy for severe proliferative diabetic retinopathy have improved as a result of
improved understanding of the pathoanatomy and improvements in surgical instrumentation. 2-5
Although anatomical success is high after complete vitrectomy, recurrent epiretinal membrane
may cause macular thickening, cysts formation, preventing good functional outcome. 6 An
epiretinal membrane (ERM) is a non-vascular cellular membrane that may cause symptomatic
visual disturbances due to retinal wrinkling and distortion. 7 These epiretinal membranes
have been found to be composed of fibroblasts, glial cells, macrophages, myofiboblasts, nad
retinal pigment epithelial cells. 8-9 Studies have suggested removal of internal limiting
membrane (ILM) may decrease the likelihood of post-operative ERM formation in cases of
diabetic macular edema and idiopathic ERM. It is postulated that removal of the ILM removes
the scaffold upon which myofibroblasts would proliferate. 10 Efficacy of vitrectomy including
removal of ILM was mostly described as facilitating resolution of diffuse diabetic macular
edema11 and improvement of visual acuity or in macular hole surgery in diabetic
patients. 12However, it is unknown if removal of ILM during vitreoretinal surgery in diabetic
patients with active fibrovascular proliferation is useful in preventing postoperative ERM
formation. The purpose of this study is to compare the postoperative epiretinal membrane
(ERM) formation and visual outcome in diabetic patients with active fibrovascular
proliferation who underwent vitrectomy with or without ILM peeling.
Eligibility
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- active fibrovascular proliferation with or without tractional detachment
- previous pan-retinal photocoagulation at least 3 months before
Exclusion Criteria:
- biomicroscopic evidence of macular hole
- combination of tractional and rhegmatogenous retinal detachment
- location of fibrovascular proliferation anterior to the equator
- major ocular surgery history(including, scleral buckle, glaucoma filter, cornea
transplant, vitreoretinal surgery etc
- the presence of other ocular conditions such as glaucoma, uveitis, or other ocular
inflammatory diseases.
Locations and Contacts
Pei-yao Chang, M.D., Phone: 886-2-23123456, Ext: 5187, Email: peiyao@seed.net.tw
National Taiwan University Hospital, Taipei, Taiwan; Recruiting
Chung-may Yang, M.D., Phone: 886-2-23123456, Ext: 5187, Email: peiyao@seed.net.tw
Additional Information
Starting date: April 2007
Ending date: November 2007
Last updated: November 8, 2007
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