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Diabetic Macular Edema and Diabetic Retinopathy Screening (TeleMed) With Automated Retinal Photography (DIVER)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Retina Institute of Hawaii.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01790945
First Posted: February 13, 2013
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Retina Institute of Hawaii
  Purpose
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.

Condition
Mild Nonproliferative Diabetic Retinopathy Moderate Nonproliferative Diabetic Retinopathy Severe Nonproliferative Diabetic Retinopathy Proliferative Diabetic Retinopathy Diabetic Macular Edema

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Diabetic Macular Edema and Diabetic Retinopathy Identification by Screening (Telemed) With Verified Automated Retinal Photography

Resource links provided by NLM:


Further study details as provided by Retina Institute of Hawaii:

Primary Outcome Measures:
  • % change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Change in HgA1C from Primary Care Physician referral to post retinal specialist visit [ Time Frame: six months ]

Other Outcome Measures:
  • Time from PCP referral for patient to see an ophthalmologist and appointment with retinal specialist [ Time Frame: 6 months ]

Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment Study
Population of subjects will have been diagnosed with mild NPDR, Moderate NPDR, Severe NPDR, PDR and DME

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
(n=500) A large population will need to be screened to find 100-150 patients with diabetic eye disease
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790945


Locations
United States, Hawaii
Craig Kadooka, MD Not yet recruiting
Hilo, Hawaii, United States, 96720
Contact: Debra L Shimabukuro, RN    808-348-9247    deb@retinahawaii.com   
Contact: Anovale Semisi    808-955-0255    anovale@retinahawaii.com   
Sub-Investigator: Craig Kadooka, MD         
Sponsors and Collaborators
Retina Institute of Hawaii
Investigators
Principal Investigator: Michael D Bennett, MD Retina Institute of Hawaii
  More Information

Responsible Party: Retina Institute of Hawaii
ClinicalTrials.gov Identifier: NCT01790945     History of Changes
Other Study ID Numbers: DIVER Study
First Submitted: February 11, 2013
First Posted: February 13, 2013
Last Update Posted: February 13, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases