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

Patients With Proliferative Diabetic Retinopathy Who Have Active Fibrovascular Proliferation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00556244
• Other study ID #: 200704053M
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 8, 2007
• Last updated: November 8, 2007
• Start date: April 2007
• Est. completion date: November 2007

Study information

• Verified date: April 2007
• Source: National Taiwan University Hospital
• Contact: Pei-yao Chang, M.D.
• Phone: 886-2-23123456
• Email: peiyao[@]seed.net.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Patients With Proliferative Diabetic Retinopathy Who Have Active Fibrovascular Proliferation

Intervention

Procedure:
• ILM peeling
ILM maculorhexis is initiated using scraper and completed using a 25-gauge Synergetics (St. Louis, MO) forceps.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Snellen BCVA and epiretinal membrane formation measured with OCT		within 6 months after the surgery
Secondary	central macular thickness measured bt OCT		within 6 months after the surgery