Pars Plana Vitrectomy for Diabetic Fibrovascular Proliferation With and Without Internal Limiting Membrane Peeling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00556244
Recruitment Status : Unknown
Verified April 2007 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : November 9, 2007
Last Update Posted : November 9, 2007
Information provided by:
National Taiwan University Hospital

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

Condition or disease Intervention/treatment Phase
Patients With Proliferative Diabetic Retinopathy Who Have Active Fibrovascular Proliferation Procedure: ILM peeling Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Pars Plana Vitrectomy for Diabetic Fibrovascular Proliferation With and Without Internal Limiting Membrane Peeling
Study Start Date : April 2007
Estimated Study Completion Date : November 2007

Arm Intervention/treatment
Active Comparator: 2 Procedure: ILM peeling
ILM maculorhexis is initiated using scraper and completed using a 25-gauge Synergetics (St. Louis, MO) forceps.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00556244

Contact: Pei-yao Chang, M.D. 886-2-23123456 ext 5187

National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chung-may Yang, M.D.    886-2-23123456 ext 5187   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Chung-may Yang, M.D. National Taiwan University Hospital Identifier: NCT00556244     History of Changes
Other Study ID Numbers: 200704053M
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: November 9, 2007
Last Verified: April 2007

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