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

NCT ID: NCT00556244

Last Updated: 2007-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Patients With Proliferative Diabetic Retinopathy Who Have Active Fibrovascular Proliferation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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2

Group Type ACTIVE_COMPARATOR

ILM peeling

Intervention Type PROCEDURE

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

Interventions

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ILM peeling

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Chung-may Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Pei-yao Chang, M.D.

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Chung-may Yang, M.D.

Role: primary

Other Identifiers

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200704053M

Identifier Type: -

Identifier Source: org_study_id