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

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ClinicalTrials.gov Identifier: NCT01758757
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : January 1, 2013
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University

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

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Procedure: Vitrectomy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 347 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Proliferative diabetic retinopathy Procedure: Vitrectomy



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

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


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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Older Adult)
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.

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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

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 Posted: January 1, 2013    Key Record Dates
Last Update Posted: January 1, 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