NCT03522311

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

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

January 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

3.2 years

First QC Date

April 28, 2018

Last Update Submit

May 9, 2018

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Visual acuity measurement

    Visual acuity improvement from baseline

    6 months

Secondary Outcomes (1)

  • Presence of postoperative vitreous hemorrhage

    6 months

Other Outcomes (1)

  • Presence of postoperative retinal detachment

    6 months

Interventions

VitrectomyPROCEDURE

Eligibility Criteria

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

The eyes with proliferative diabetic retinopathy

You may qualify if:

  • The patients had25-gauge vitrectomy for proliferative diabetic retinopathy

You may not qualify if:

  • The patients had hemodialysis , followed up less than 6 months, had vitrectomy for diabetic macular edema and macular ration but not macular detachment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Makoto Inoue, MD

    Kyorin Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Ophthalmology

Study Record Dates

First Submitted

April 28, 2018

First Posted

May 11, 2018

Study Start

January 1, 2013

Primary Completion

March 1, 2016

Study Completion

October 1, 2016

Last Updated

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share