Recruiting

FDT Testing

Sponsor:

University of Miami

Code:

NCT02862158

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FDT visual field

Standard HVF

Study Details

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.

Conditions

Glaucoma

Study ID

NCT02862158

Start date

Aug, 2016

Status verified date

Oct, 2020

Completion date

Nov, 2022

Anticipated

Primary completion date

Nov, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Experimental

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

Interventions

FDT visual field

Standard HVF

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Richard K Lee, MD, PhD

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

Locations

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

Recruiting

Miami, Florida, United States, 33136

More Information

Sponsor

University of Miami

Last update posted

Oct 30, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2020-10-30.