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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00556244
First received: November 8, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Pars Plana Vitrectomy for Diabetic Fibrovascular Proliferation With and Without Internal Limiting Membrane Peeling

Resource links provided by NLM:


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
Active Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on October 30, 2014