Diabetic Macular Edema
Conditions
Brief summary
This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography
Interventions
None listed
Sponsors
Genentech, Inc.
Elman Retina Group
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age \> 18 years * Patient related considerations * Patients with diabetes mellitus * Disease related considerations * Diabetes mellitus
Exclusion criteria
* Prior admission screening within twelve months. * Inability to sit for evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the incidence of new and/or undiagnosed diabetic macular edema. | 1 day (Patients are only seen once for assessments) | This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Streamlining and identification of patients at risk of diabetic macular edema | 1 day (Patients only seen once for assessments) | Establish methods for streamlining screening and identification of patients at risk. Establish methods for referral for treatment of patients identified with vision threatening diabetic retinopathy. |
Countries
United States
Contacts
Primary ContactJennifer Belz
Outcome results
None listed