Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Comparison of Small-gauge and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
Verified date | December 2012 |
Source | Kyorin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Institutional Review Board |
Study type | Interventional |
Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.
Status | Completed |
Enrollment | 347 |
Est. completion date | July 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 90 Years |
Eligibility |
Inclusion Criteria: - The patients of proliferative diabetic retinopathy who underwent vitreous surgery and followed at least 6 months Exclusion Criteria: - The patients of proliferative diabetic retinopathy who underwent vitreous surgery but did not follow more than 6 months. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Kyorin Eye Center | Mitaka | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Kyorin University |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of retinal breaks | One year | No | |
Secondary | Incidence of neovascular glaucoma | One Year | No |
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