Frequency Doubling Technology (FDT) Mobile Visual Field Testing

• ClinicalTrials.gov Identifier: NCT02862158
• Recruitment Status: Recruiting
• First Posted: August 10, 2016
• Last Update Posted: October 30, 2020
• Sponsor: University of Miami
• Information provided by (Responsible Party): Richard K. Lee, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Glaucoma	Device: FDT visual field; Device: Standard HVF	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Different Frequency Doubling Technology (FDT) Mobile Devices for Visual Field Assessment
• Study Start Date: August 2016
• Estimated Primary Completion Date: November 2022
• Estimated Study Completion Date: November 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental; FDT visual field will be compared to standard HVF in detecting glaucomatous visual field loss	Device: FDT visual field; Device: Standard HVF

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Mean deviation (MD) 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
2. Pattern standard deviation (PSD) 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Richard K Lee, MD, PhD; 305-326-6000; rlee@med.miami.edu

Locations

United States, Florida

Bascom Palmer Eye Institute, University of Miami Miller School of Medicine; Recruiting

Miami, Florida, United States, 33136

Contact: Richard K Lee, MD, PhD

Sponsors and Collaborators

University of Miami

Investigators

• Principal Investigator: Richard Lee, MD, PhD; University of Miami / Bascom Palmer Eye Institute

More Information

Publications:

Guirguis-Blake J. Rationale for the USPSTF recommendation on screening for glaucoma. Am Fam Physician. 2005 Oct 1;72(7):1184, 1187.

Moyer VA; U.S. Preventive Services Task Force. Screening for glaucoma: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2013 Oct 1;159(7):484-9.

Mansberger SL, Johnson CA, Cioffi GA, Choi D, Krishnadas SR, Srinivasan M, Balamurugan V, Kim U, Smith SD, Wilkins JH, Gritz DC. Predictive value of frequency doubling technology perimetry for detecting glaucoma in a developing country. J Glaucoma. 2005 Apr;14(2):128-34.

Nomoto H, Matsumoto C, Takada S, Hashimoto S, Arimura E, Okuyama S, Shimomura Y. Detectability of glaucomatous changes using SAP, FDT, flicker perimetry, and OCT. J Glaucoma. 2009 Feb;18(2):165-71. doi: 10.1097/IJG.0b013e318179f7ca.

• Responsible Party: Richard K. Lee, Associate Professor of Ophthalmology, Cell Biology and Neuroscience Graduate Program, University of Miami
• ClinicalTrials.gov Identifier: NCT02862158
• Other Study ID Numbers: 20150968
• First Posted: August 10, 2016
• Last Update Posted: October 30, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Eye Diseases