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Pars Plana Vitrectomy for Diabetic Fibrovascular Proliferation With and Without Internal Limiting Membrane Peeling
This study is currently recruiting participants.
Verified by National Taiwan University Hospital, April 2007
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00556244
  Purpose

Internal limiting membrane peeling in diabetic vitrectomy will help prevent postoperative epiretinal membrane formation


Condition Intervention Phase
Patients With Proliferative Diabetic Retinopathy Who Have Active Fibrovascular Proliferation
Procedure: ILM peeling
Phase I
Phase II

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders
Drug Information available for: Temazepam
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind (Investigator), Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Pars Plana Vitrectomy for Diabetic Fibrovascular Proliferation With and Without Internal Limiting Membrane Peeling

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Snellen BCVA and epiretinal membrane formation measured with OCT [ Time Frame: within 6 months after the surgery ]

Secondary Outcome Measures:
  • central macular thickness measured bt OCT [ Time Frame: within 6 months after the surgery ]

Estimated Enrollment: 40
Study Start Date: April 2007
Estimated Study Completion Date: November 2007
Arms Assigned Interventions
2: Active Comparator Procedure: ILM peeling
ILM maculorhexis is initiated using scraper and completed using a 25-gauge Synergetics (St. Louis, MO) forceps.

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556244

Contacts
Contact: Pei-yao Chang, M.D. 886-2-23123456 ext 5187 peiyao@seed.net.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chung-may Yang, M.D.     886-2-23123456 ext 5187     peiyao@seed.net.tw    
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chung-may Yang, M.D. National Taiwan University Hospital
Principal Investigator: Chung-may Yang, M.D. National Taiwan University Hospital
  More Information

Study ID Numbers: 200704053M
Study First Received: November 8, 2007
Last Updated: November 8, 2007
ClinicalTrials.gov Identifier: NCT00556244  
Health Authority: Taiwan: Department of Health

Study placed in the following topic categories:
Diabetic Retinopathy
Eye Diseases
Temazepam
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Endocrinopathy
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009