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NCT01758757 Clinical Trial

Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:
Comparison of Small-gauge and Conventional Vitrectomy for Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01758757
Other study ID # Kyorineye010
Secondary ID Vitrectomy for P
Status Completed
Phase N/A
First received December 27, 2012
Last updated December 31, 2012
Start date September 2007
Est. completion date July 2011

Study information
Verified date December 2012
Source Kyorin University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.

Description:

The 424 eyes of 347 patients of PDR who underwent vitreous surgery for persistent vitreous hemorrhage or progressive proliferative membrane were evaluated.

Recruitment information / eligibility
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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Vitrectomy

Locations
Country Name City State
Japan Kyorin Eye Center Mitaka Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Kyorin University

Country where clinical trial is conducted

Japan, 

Outcome
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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