Frequency Doubling Technology (FDT) Mobile Visual Field Testing

Not Applicable

• Conditions: Glaucoma
• Interventions: Device: FDT visual field; Device: Standard HVF

• Registration Number: NCT02862158
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-07-18
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-06
• Study First Posted: 2016-08-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-30
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	FDT visual field	FDT visual field will be compared to standard HVF in detecting glaucomatous visual field loss
Experimental	Standard HVF	FDT visual field will be compared to standard HVF in detecting glaucomatous visual field loss

Primary Outcome Measures

Name	Time	Method
Pattern of visual field loss 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.	Visual Field

Secondary Outcome Measures

Name	Time	Method
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.	Visual Field
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.	Visual Field

Trial Locations

Locations (1)

Bascom Palmer Eye Institute, University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States