Efficacy of Higher Cutting Rate in Microincision Vitrecto... | NCT02464800

Studies
Efficacy of Higher Cutting Rate in Microincision Vitrectomy for Proliferative Diabetic Retinopathy

NCT02464800

Sponsor

Kyorin University

Status

Completed

Last Update Posted

Jun 8, 2015Estimated

Enrollment

326Actual

Phase

Not provided

Conditions

Proliferative Diabetic Retinopathy

Interventions

Vitrectomy for proliferative diabetic retinopathy

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

Status Module

Record Verification Date

Jun 2015

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

Apr 2007

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jun 2, 2015

First Submission Date that Met QC Criteria

Jun 3, 2015

First Posted Date

Jun 8, 2015Estimated

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

Jun 3, 2015

Last Update Posted Date

Jun 8, 2015Estimated

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

The medical records of 393 eyes of 326 patients with severe proliferative diabetic retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used in 174 eyes and conventional instruments in 219 eyes (2500 cut per minute). The visual outcome and incidences of intraoperative and postoperative complications were compared.

Detailed Description

Not provided

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

326Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Higher cutting rate group		Vitrectomy with higher cutting rate instruments (5000 cut per minute) were performed in 174 eyes for proliferative diabetic retinopathy	Procedure: Vitrectomy for proliferative diabetic retinopathy
Conventional cutting rate group		Vitrectomy with conventional instruments (2500 cut per minute) were performed in 219 eyes for proliferative diabetic retinopathy	Procedure: Vitrectomy for proliferative diabetic retinopathy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitrectomy for proliferative diabetic retinopathy	Procedure	25-gauge vitrectomy	Conventional cutting rate group Higher cutting rate group

Measure	Description	Time Frame
Visual acuity		6 months

Measure	Description	Time Frame
Retinal reattachment		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The inclusion criteria were patients who had persistent vitreous hemorrhage, fibrovascular proliferation affecting the macula, or tractional RD and who had a follow-up for more than 6 months.

Exclusion Criteria:

The eyes with follow-up less than 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

The patients who underwent 25-gauge vitrectomy for proliferative diabetic retinopathy with higher cutting rate instruments or conventional instruments

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Makoto Inoue		Mitaka	Tokyo	181-8611	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

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

Not provided

Browse Branches

Not provided