Back to resultsComparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
Primary Purpose
Proliferative Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Proliferative diabetic retinopathy, Vitrectomy
Eligibility 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.
Sites / Locations
- Kyorin Eye Center
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Proliferative diabetic retinopathy
Arm Description
Outcomes
Primary Outcome Measures
Incidence of retinal breaks
Secondary Outcome Measures
Incidence of neovascular glaucoma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01758757
Brief Title
Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
Official Title
Comparison of Small-gauge and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyorin University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.
Detailed Description
The 424 eyes of 347 patients of PDR who underwent vitreous surgery for persistent vitreous hemorrhage or progressive proliferative membrane were evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
Proliferative diabetic retinopathy, Vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
347 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proliferative diabetic retinopathy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy
Primary Outcome Measure Information:
Title
Incidence of retinal breaks
Time Frame
One year
Secondary Outcome Measure Information:
Title
Incidence of neovascular glaucoma
Time Frame
One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makoto Inoue, MD
Organizational Affiliation
Kyorin Eye Center
Official's Role
Study Chair
Facility Information:
Facility Name
Kyorin Eye Center
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26202442
Citation
Yokota R, Inoue M, Itoh Y, Rii T, Hirota K, Hirakata A. Comparison of microinsicion vitrectomy and conventional 20-gauge vitrectomy for severe proliferative diabetic retinopathy. Jpn J Ophthalmol. 2015 Sep;59(5):288-94. doi: 10.1007/s10384-015-0396-y. Epub 2015 Jul 23. Erratum In: Jpn J Ophthalmol. 2015 Nov;59(6):436.
Results Reference
derived
Learn more about this trial
Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
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