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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01790945
Other study ID # DIVER Study
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 11, 2013
Last updated February 12, 2013
Start date February 2013
Est. completion date August 2013

Study information

Verified date February 2013
Source Retina Institute of Hawaii
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

Retina Institute of Hawaii will place an infrastructure to screen for diabetic retinopathy/diabetic macular edema in 5 of the states largest Primary Care Clinics, General Medical and or Endocrine practices which re our primary referrals for diabetes patients. Each Sub-site will receive a DRS Automated Retinal Camera and our staff will train the sub-site's staff on taking images. The submission of these images to our practice will be administered by an automated job scheduler in the DRS Automated Retinal Camera removing the requirement of the locations to send images. Images will be electronically uploaded and sent to the Retina Institute of Hawaii for detailed interpretation and report sent back to the patients, their diabetes care MD's and their nurse practitioners/diabetic educators.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date August 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Patients with diabetes already under the care of an Ophthalmologist.

- Patient not willing to give Consent for participation in the study

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Craig Kadooka, MD Hilo Hawaii

Sponsors (1)

Lead Sponsor Collaborator
Retina Institute of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Time from PCP referral for patient to see an ophthalmologist and appointment with retinal specialist 6 months No
Primary % change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system 6 months No
Secondary Change in HgA1C from Primary Care Physician referral to post retinal specialist visit six months No
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