Surgical Outcomes for Proliferative Diabetic Retinopathy by Preoperative Glycemic Control and Renal Function
Sponsor
Kyorin University (Other)
Overall Status
Completed
CT.gov ID
NCT03522311
Collaborator
(none)
251
45
Study Details
Study Description
Brief Summary
The surgical outcomes of 25-gauge vitrectomy for proliferative diabetic retinopathy has been evaluated by preoperative glycemic control and renal function
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The purpose of this study is to evaluate the surgical outcomes of 25-gauge vitrectomy for proliferative diabetic retinopathy by preoperative glycemic control and renal function.
Study Design
Study Type:
Observational
Actual Enrollment
:
251 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Evaluation of 25-gauge Vitrectomy Surgical Outcomes for Proliferative Diabetic Retinopathy by Preoperative Glycemic Control and Renal Function
Actual Study Start Date
:
Jan 1, 2013
Actual Primary Completion Date
:
Mar 1, 2016
Actual Study Completion Date
:
Oct 1, 2016
Outcome Measures
Primary Outcome Measures
- Visual acuity measurement [6 months]
Visual acuity improvement from baseline
Secondary Outcome Measures
- Presence of postoperative vitreous hemorrhage [6 months]
Incidence of postoperative vitreous hemorrhage
Other Outcome Measures
- Presence of postoperative retinal detachment [6 months]
Incidence of postoperative retinal detachment
Eligibility Criteria
Criteria
Ages Eligible for Study:
10 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- The patients had25-gauge vitrectomy for proliferative diabetic retinopathy
Exclusion Criteria:
- The patients had hemodialysis , followed up less than 6 months, had vitrectomy for diabetic macular edema and macular ration but not macular detachment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kyorin University
Investigators
- Principal Investigator: Makoto Inoue, MD, Kyorin Eye Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Makoto Inoue,
Department of Ophthalmology,
Kyorin University
ClinicalTrials.gov Identifier:
NCT03522311
Other Study ID Numbers:
- Kyorineye025
First Posted:
May 11, 2018
Last Update Posted:
May 11, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: