NCT01758757

Brief Summary

Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
Last Updated

January 1, 2013

Status Verified

December 1, 2012

Enrollment Period

3.3 years

First QC Date

December 27, 2012

Last Update Submit

December 31, 2012

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative diabetic retinopathyVitrectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of retinal breaks

    One year

Secondary Outcomes (1)

  • Incidence of neovascular glaucoma

    One Year

Study Arms (1)

Proliferative diabetic retinopathy

ACTIVE COMPARATOR
Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE
Proliferative diabetic retinopathy

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patients of proliferative diabetic retinopathy who underwent vitreous surgery and followed at least 6 months

You may not qualify if:

  • The patients of proliferative diabetic retinopathy who underwent vitreous surgery but did not follow more than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

Location

Related Publications (1)

  • 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.

    PMID: 26202442DERIVED

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Makoto Inoue, MD

    Kyorin Eye Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kyorin Eye Center

Study Record Dates

First Submitted

December 27, 2012

First Posted

January 1, 2013

Study Start

September 1, 2007

Primary Completion

January 1, 2011

Study Completion

July 1, 2011

Last Updated

January 1, 2013

Record last verified: 2012-12

Locations

JP(1)