Identifying Patients With Unrecognized Treatable Diabetic Macular Edema

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2019

Clinical Trial Outcome Measures

Primary Measures

  • Assess the incidence of new and/or undiagnosed diabetic macular edema.
    • Time Frame: 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 Measures

  • Streamlining and identification of patients at risk of diabetic macular edema
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Elman Retina Group
  • Collaborator
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael J Elman, MD, Principal Investigator, Elman Retina Group, P.A.
  • Overall Contact(s)
    • Jennifer Belz, 4106863000, belz@elmanretina.com

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