N/A
N=385
OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits
Diabetes · Diabetic Macular Edema · Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT01875783 ↗Enrolled (actual)
385
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Rates of Retina Care Referral for Patients With Diabetic Macular Edema — 44 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OCT imaging (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Joslin Diabetes Center
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Retina Care Referral for Patients With Diabetic Macular Edema |
44 | — |
| SECONDARY Retinal Referral Rates for Patients With DME |
59 | — |
| SECONDARY Rates of Retinal Treatment for Patients With DME |
14 | — |
| SECONDARY Rates of Retinal Treatment Over 1 Year for Patients With DME |
18 | — |
Summary
The purpose of this protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.
Eligibility Criteria
Inclusion Criteria
- Type 1 or type 2 diabetes mellitus as evidenced by:
- Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR
- Documented diabetes by American Diabetes Association and/or World Health Organization criteria
- Age greater than or equal to 18 years old
- Diabetes duration of 10 more years OR last measured HbA1c of 10% or more
- Able and willing to participate in study procedures and comply with study follow-up visits
- Able to give informed consent for study participation
- Not moving out of the study area during the 1 year follow-up period
Exclusion Criteria
- Unable to cooperate with the OCT image acquisition procedure or other study procedures
- Unable or unwilling to comply with the study follow-up visits
- Unable or unwilling to sign form for release of retinal medical records
Data sourced from ClinicalTrials.gov (NCT01875783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.