NCT01307072

Brief Summary

The relationship between the surgical outcome of vitreous surgery for proliferative diabetic retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

March 1, 2011

Last Update Submit

July 31, 2012

Conditions

Proliferative Diabetic Retinopathy

Keywords

periodic examinations, compliance

Outcome Measures

Primary Outcomes (2)

  • Preoperative status

    Plasma level of glycosylated hemoglobin (HbA1c)

    Preoperative period

  • Preoperative status

    Best-corrected visual acuity (BCVA),

    Preoperative period

Secondary Outcomes (3)

  • Postoperative status

    up to 1 year

  • Postoperative status

    up to 1 year

  • Postoperative status

    up to 1 year

Study Arms (3)

Never-treated group

The patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed

Procedure: Vitrectomy

The non-compliant group

The patients with a history of missing ophthalmic examination over a one year period

Procedure: Vitrectomy

The compliant group

The patients who had ophthalmic examinations at least once a year

Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE

Vitrectomy. Diabetic retinopathy

Also known as: Compliance of follow-up
Never-treated groupThe compliant groupThe non-compliant group

Eligibility Criteria

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

The patients that underwent their first vitreous surgery for proliferaftive diabetic retinopathy

You may qualify if:

  • One hundred and twenty-eight eyes of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy.
  • Type 2 diabetes.

You may not qualify if:

  • The patients were not followed 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

MeSH Terms

Conditions

Patient Compliance

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

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
Associate professor

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 2, 2011

Study Start

September 1, 2008

Primary Completion

August 1, 2009

Study Completion

April 1, 2010

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

JP(1)