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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
ClinicalTrials.gov Identifier:
NCT01758757
First received: December 27, 2012
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Proliferative Diabetic Retinopathy
 Procedure: Vitrectomy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Small-gauge and Conventional Vitrectomy for Proliferative Diabetic Retinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyorin University:

Primary Outcome Measures:
  • Incidence of retinal breaks [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of neovascular glaucoma [ Time Frame: One Year ] [ Designated as safety issue: No ]

Enrollment: 347
Study Start Date: September 2007
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Proliferative diabetic retinopathy Procedure: Vitrectomy

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   10 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758757

Locations
Japan
Kyorin Eye Center
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
Study Chair: Makoto Inoue, MD Kyorin Eye Center
  More Information

No publications provided

Responsible Party: Makoto Inoue, Kyorin Eye Center, Kyorin University
ClinicalTrials.gov Identifier: NCT01758757     History of Changes
Other Study ID Numbers: Kyorineye010, Vitrectomy for PDR
Study First Received: December 27, 2012
Last Updated: December 31, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin University:
Proliferative diabetic retinopathy
Vitrectomy

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013