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Frequency Doubling Technology (FDT) Mobile Visual Field Testing

NCT ID: NCT02862158

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2022-11-30

Brief Summary

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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

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental

FDT visual field will be compared to standard HVF in detecting glaucomatous visual field loss

Group Type EXPERIMENTAL

FDT visual field

Intervention Type DEVICE

Standard HVF

Intervention Type DEVICE

Interventions

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FDT visual field

Intervention Type DEVICE

Standard HVF

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Richard K. Lee

Associate Professor of Ophthalmology, Cell Biology and Neuroscience Graduate Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami / Bascom Palmer Eye Institute

Locations

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

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Richard K Lee, MD, PhD

Role: CONTACT

[email protected]
305-326-6000

Facility Contacts

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Richard K Lee, MD, PhD

Role: primary

References

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Guirguis-Blake J. Rationale for the USPSTF recommendation on screening for glaucoma. Am Fam Physician. 2005 Oct 1;72(7):1184, 1187. No abstract available.

Reference Type BACKGROUND
PMID: 16225022 (View on PubMed)

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. doi: 10.7326/0003-4819-159-6-201309170-00686.

Reference Type BACKGROUND
PMID: 24325017 (View on PubMed)

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. doi: 10.1097/01.ijg.0000151883.07232.54.

Reference Type BACKGROUND
PMID: 15741814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19225357 (View on PubMed)

Other Identifiers

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20150968

Identifier Type: -

Identifier Source: org_study_id