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

December 31, 2012 updated by: Makoto Inoue, Kyorin University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

347

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Proliferative diabetic retinopathy
Procedure: Vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of retinal breaks
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of neovascular glaucoma
Time Frame: One Year
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyorin University

Investigators

  • Study Chair: Makoto Inoue, MD, Kyorin Eye Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 27, 2012

First Submitted That Met QC Criteria

December 31, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Estimate)

January 1, 2013

Last Update Submitted That Met QC Criteria

December 31, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kyorineye010
  • Vitrectomy for PDR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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