COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Frequency Doubling Technology (FDT) Mobile Visual Field Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02862158
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Richard K. Lee, University of Miami

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862158


Contacts
Layout table for location contacts
Contact: Richard K Lee, MD, PhD 305-326-6000 rlee@med.miami.edu

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Richard Lee, MD, PhD University of Miami / Bascom Palmer Eye Institute
Publications:
Layout table for additonal information
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    Key Record Dates
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:
Layout table for MeSH terms
Glaucoma
Ocular Hypertension
Eye Diseases