NCT01790945

Brief Summary

The purpose of this study is explore if a partnership and screening program put in place between a busy retina practice and their referring diabetes care offices can improve diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in patients with diabetic eye disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

4 months

First QC Date

February 11, 2013

Last Update Submit

February 12, 2013

Conditions

Mild Nonproliferative Diabetic RetinopathyModerate Nonproliferative Diabetic RetinopathySevere Nonproliferative Diabetic RetinopathyProliferative Diabetic RetinopathyDiabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • % change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system

    6 months

Secondary Outcomes (1)

  • Change in HgA1C from Primary Care Physician referral to post retinal specialist visit

    six months

Other Outcomes (1)

  • Time from PCP referral for patient to see an ophthalmologist and appointment with retinal specialist

    6 months

Study Arms (1)

No treatment Study

Population of subjects will have been diagnosed with mild NPDR, Moderate NPDR, Severe NPDR, PDR and DME

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

(n=500) A large population will need to be screened to find 100-150 patients with diabetic eye disease

You may qualify if:

  • Patients diagnosed with diabetes that have not seen an Ophthalmologist in the past 1 year

You may not qualify if:

  • Patients with diabetes already under the care of an Ophthalmologist.
  • Patient not willing to give Consent for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Craig Kadooka, MD

Hilo, Hawaii, 96720, United States

Location

Study Officials

  • Michael D Bennett, MD

    Retina Institute of Hawaii

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

US(1)