Surgical Outcomes for Proliferative Diabetic Retinopathy... | NCT03522311

Studies
Surgical Outcomes for Proliferative Diabetic Retinopathy by Preoperative Glycemic Control and Renal Function

NCT03522311

Sponsor

Kyorin University

Status

Completed

Last Update Posted

May 11, 2018Actual

Enrollment

251Actual

Phase

Not provided

Conditions

Proliferative Diabetic Retinopathy

Interventions

Vitrectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013Actual

Primary Completion Date

Mar 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Apr 28, 2018

First Submission Date that Met QC Criteria

May 9, 2018

First Posted Date

May 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2018

Last Update Posted Date

May 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The surgical outcomes of 25-gauge vitrectomy for proliferative diabetic retinopathy has been evaluated by preoperative glycemic control and renal function

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

251Actual

Name	Type	Description	Arm Group Labels	Other Names
Vitrectomy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity measurement	Visual acuity improvement from baseline	6 months

Secondary Outcomes

Measure	Description	Time Frame
Presence of postoperative vitreous hemorrhage	Incidence of postoperative vitreous hemorrhage	6 months

Other Outcomes

Measure	Description	Time Frame
Presence of postoperative retinal detachment	Incidence of postoperative retinal detachment	6 months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

The eyes with proliferative diabetic retinopathy

Sampling Method

Probability Sample

Name	Affiliation	Role
Makoto Inoue, MD	Kyorin Eye Center	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014821	Vitrectomy

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

Not provided