Frequency Doubling Technology (FDT) Mobile Visual Field Testing

Glaucoma Clinical Trial

Official title:

Evaluation of Different Frequency Doubling Technology (FDT) Mobile Devices for Visual Field Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02862158
• Other study ID #: 20150968
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: November 2022

Study information

• Verified date: October 2020
• Source: University of Miami
• Contact: Richard K Lee, MD, PhD
• Phone: 305-326-6000
• Email: rlee[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• FDT visual field

• Standard HVF

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute, University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of visual field loss in FDT visual fields as compared with standard HVF	Visual Field	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.
Secondary	Mean deviation (MD) in FDT visual fields as compared with standard HVF	Visual Field	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.
Secondary	Pattern standard deviation (PSD) in FDT visual fields as compared with standard HVF	Visual Field	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.