MedPath

Identifying Patients With Unrecognized Treatable Diabetic Macular Edema

Conditions
Diabetic Macular Edema
Registration Number
NCT01934920
Lead Sponsor
Elman Retina Group
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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
500
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Streamlining and identification of patients at risk of diabetic macular edema1 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.

Trial Locations

Locations (2)

Aaron Goldberg, Primary Care

🇺🇸

Baltimore, Maryland, United States

MedStar Hospital

🇺🇸

Baltimore, Maryland, United States

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