Diabetic Macular Edema and Diabetic Retinopathy Screening (TeleMed) With Automated Retinal Photography (DIVER)
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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 |
- % change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in HgA1C from Primary Care Physician referral to post retinal specialist visit [ Time Frame: six months ] [ Designated as safety issue: No ]
- Time from PCP referral for patient to see an ophthalmologist and appointment with retinal specialist [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
(n=500) A large population will need to be screened to find 100-150 patients with diabetic eye disease
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| 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 | |
| Principal Investigator: | Michael D Bennett, MD | Retina Institute of Hawaii |
More Information
No publications provided
| Responsible Party: | Retina Institute of Hawaii |
| ClinicalTrials.gov Identifier: | NCT01790945 History of Changes |
| Other Study ID Numbers: | DIVER Study |
| Study First Received: | February 11, 2013 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Edema Macular Edema Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Signs and Symptoms Macular Degeneration Retinal Degeneration |
ClinicalTrials.gov processed this record on June 13, 2013