Efficacy of Higher Cutting Rate in Microincision Vitrectomy for Proliferative Diabetic Retinopathy

June 3, 2015 updated by: Makoto Inoue, Kyorin University
The medical records of 393 eyes of 326 patients with severe proliferative diabetic retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used in 174 eyes and conventional instruments in 219 eyes (2500 cut per minute). The visual outcome and incidences of intraoperative and postoperative complications were compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

326

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
        • Makoto Inoue

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

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients who underwent 25-gauge vitrectomy for proliferative diabetic retinopathy with higher cutting rate instruments or conventional instruments

Description

Inclusion Criteria:

  • The inclusion criteria were patients who had persistent vitreous hemorrhage, fibrovascular proliferation affecting the macula, or tractional RD and who had a follow-up for more than 6 months.

Exclusion Criteria:

  • The eyes with follow-up less 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Higher cutting rate group
Vitrectomy with higher cutting rate instruments (5000 cut per minute) were performed in 174 eyes for proliferative diabetic retinopathy
Procedure: Vitrectomy for proliferative diabetic retinopathy
25-gauge vitrectomy
Conventional cutting rate group
Vitrectomy with conventional instruments (2500 cut per minute) were performed in 219 eyes for proliferative diabetic retinopathy
Procedure: Vitrectomy for proliferative diabetic retinopathy
25-gauge vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Retinal reattachment
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Kyorin University

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

April 1, 2007

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kyorineye016

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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