NCT02862158

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

6.3 years

First QC Date

July 18, 2016

Last Update Submit

October 28, 2020

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

Study Arms (1)

Experimental

EXPERIMENTAL

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

Device: FDT visual fieldDevice: Standard HVF

Interventions

FDT visual fieldDEVICE
Experimental
Standard HVFDEVICE
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Miami, Florida, 33136, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 16225022BACKGROUND

  • 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.

    PMID: 24325017BACKGROUND

  • 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.

    PMID: 15741814BACKGROUND

  • 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.

    PMID: 19225357BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Richard Lee, MD, PhD

    University of Miami / Bascom Palmer Eye Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard K Lee, MD, PhD

CONTACT

305-326-6000rlee@med.miami.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology, Cell Biology and Neuroscience Graduate Program

Study Record Dates

First Submitted

July 18, 2016

First Posted

August 10, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

October 30, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)