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NCT02464800 Clinical Trial

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

Proliferative Diabetic Retinopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02464800
Other study ID # Kyorineye016
Secondary ID
Status Completed
Phase N/A
First received June 2, 2015
Last updated June 3, 2015
Start date April 2007
Est. completion date March 2015

Study information
Verified date June 2015
Source Kyorin University
Contact n/a
Is FDA regulated No
Health authority Institutional review board: Japan
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 326
Est. completion date March 2015
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Vitrectomy for proliferative diabetic retinopathy
25-gauge vitrectomy

Locations
Country Name City State
Japan Makoto Inoue 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 Visual acuity 6 months Yes
Secondary Retinal reattachment 6 months Yes
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Completed NCT02879422 - Genetic Markers and Proliferative Diabetic Retinopathy N/A
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