Evaluation of Different Frequency Doubling Technology (FDT) Mobile Devices for Visual Field Assessment
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Miami
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Pattern of visual field loss in FDT visual fields as compared with standard HVF
Study Overview
Brief Summary
This is a single center, prospective study to evaluate the efficacy and reproducibility of frequency doubling technology (FDT)-based visual field devices compared to conventional Humphrey Visual Field (HVF) perimetry. The investigators plan to enroll 500 patients in this study.
Detailed Description
Glaucoma is a leading cause of irreversible and preventable blindness world-wide. Insufficient evidence exists to support routine screening for glaucoma in a primary care setting due to the relatively low prevalence of the disease (Guirguis-Blake, 2005 and Moyer, 2013). Frequency doubling technology (FDT)-based perimetry is a relatively inexpensive and portable visual field testing device with a short testing time that has shown reasonable efficacy, sensitivity and specificity in screening for glaucoma in clinic- and community-based settings (Mansberger, 2005 and Nomoto 2009).
The aim of our study is to compare the efficacy and reproducibility of FDT perimetry platforms compared with Humphrey Visual Field (HVF) perimetry (which is the gold clinical standard in clinics and hospitals) in detecting glaucomatous visual field defects.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (18 and over) who speak English, Spanish or Creole, and are capable of providing informed consent and who have a Humphrey Visual Field (HVF) test within the prior the 6 months preceding enrollment are eligible for enrollment in this non-invasive study. Patients will be recruited from among patients at the Bascom Palmer Eye Institute clinics during their regularly scheduled clinic visits. No advertising will be used to recruit patients.
Exclusion Criteria
- •Adults unable to consent, individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners and other vulnerable populations will be excluded from the study.
Arms & Interventions
Experimental
FDT visual field will be compared to standard HVF in detecting glaucomatous visual field loss
Intervention: FDT visual field (Device)
Experimental
FDT visual field will be compared to standard HVF in detecting glaucomatous visual field loss
Intervention: Standard HVF (Device)
Outcomes
Primary Outcomes
Pattern of visual field loss in FDT visual fields as compared with standard HVF
Time Frame: The investigators anticipate to enroll the subjects over a period of 12 months. The estimated time required for data analysis is 6 months following enrollment of all subjects.
Visual Field
Secondary Outcomes
- Mean deviation (MD) in FDT visual fields as compared with standard HVF(The investigators anticipate to enroll the subjects over a period of 12 months. The estimated time required for data analysis is 6 months following enrollment of all subjects.)
- Pattern standard deviation (PSD) in FDT visual fields as compared with standard HVF(The investigators anticipate to enroll the subjects over a period of 12 months. The estimated time required for data analysis is 6 months following enrollment of all subjects.)
Investigators
Richard K. Lee
Associate Professor of Ophthalmology, Cell Biology and Neuroscience Graduate Program
University of Miami