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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758757
First Posted: January 1, 2013
Last Update Posted: January 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Small-gauge and Conventional Vitrectomy for Proliferative Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Makoto Inoue, Kyorin University:

Primary Outcome Measures:
  • Incidence of retinal breaks [ Time Frame: One year ]

Secondary Outcome Measures:
  • Incidence of neovascular glaucoma [ Time Frame: One Year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Makoto Inoue, Kyorin Eye Center, Kyorin University
ClinicalTrials.gov Identifier: NCT01758757     History of Changes
Other Study ID Numbers: Kyorineye010
Vitrectomy for PDR
First Submitted: December 27, 2012
First Posted: January 1, 2013
Last Update Posted: January 3, 2013
Last Verified: December 2012

Keywords provided by Makoto Inoue, Kyorin University:
Proliferative diabetic retinopathy
Vitrectomy

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