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

Primary Purpose

Patients With Proliferative Diabetic Retinopathy Who Have Active Fibrovascular Proliferation

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
ILM peeling
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Proliferative Diabetic Retinopathy Who Have Active Fibrovascular Proliferation

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

2

Arm Description

Outcomes

Primary Outcome Measures

Snellen BCVA and epiretinal membrane formation measured with OCT

Secondary Outcome Measures

central macular thickness measured bt OCT

Full Information

First Posted
November 8, 2007
Last Updated
November 8, 2007
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00556244
Brief Title
Pars Plana Vitrectomy for Diabetic Fibrovascular Proliferation With and Without Internal Limiting Membrane Peeling
Official Title
Pars Plana Vitrectomy for Diabetic Fibrovascular Proliferation With and Without Internal Limiting Membrane Peeling
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Proliferative Diabetic Retinopathy Who Have Active Fibrovascular Proliferation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
ILM peeling
Intervention Description
ILM maculorhexis is initiated using scraper and completed using a 25-gauge Synergetics (St. Louis, MO) forceps.
Primary Outcome Measure Information:
Title
Snellen BCVA and epiretinal membrane formation measured with OCT
Time Frame
within 6 months after the surgery
Secondary Outcome Measure Information:
Title
central macular thickness measured bt OCT
Time Frame
within 6 months after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-yao Chang, M.D.
Phone
886-2-23123456
Ext
5187
Email
peiyao@seed.net.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-may Yang, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung-may Yang, M.D.
Phone
886-2-23123456
Ext
5187
Email
peiyao@seed.net.tw

12. IPD Sharing Statement

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

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