Comparison of Small-gauge Vitrectomy and Conventional Vit... | NCT01758757

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

NCT01758757

Sponsor

Kyorin University

Status

Completed

Last Update Posted

Jan 1, 2013Estimated

Enrollment

347Actual

Phase

Not Applicable

Conditions

Proliferative Diabetic Retinopathy

Interventions

Vitrectomy

Countries

Japan

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

ID	Type	Description	Link
Vitrectomy for PDR

Status Module

Record Verification Date

Dec 2012

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

Sep 2007

Primary Completion Date

Jan 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Dec 27, 2012

First Submission Date that Met QC Criteria

Dec 31, 2012

First Posted Date

Jan 1, 2013Estimated

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

Dec 31, 2012

Last Update Posted Date

Jan 1, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

347Actual

Label	Type	Description	Intervention Names
Proliferative diabetic retinopathy	Active Comparator		Procedure: Vitrectomy

Name	Type	Description	Arm Group Labels	Other Names
Vitrectomy	Procedure		Proliferative diabetic retinopathy

Measure	Description	Time Frame
Incidence of retinal breaks		One year

Measure	Description	Time Frame
Incidence of neovascular glaucoma		One Year

Eligibility Module

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.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Makoto Inoue, MD	Kyorin Eye Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyorin Eye Center		Mitaka	Tokyo	181-8611	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26202442	Derived	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.

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative