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Frequency Doubling Technology (FDT) Mobile Visual Field Testing

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDT visual field
Standard HVF
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bascom Palmer Eye Institute, University of Miami Miller School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

Pattern of visual field loss in FDT visual fields as compared with standard HVF
Visual Field

Secondary Outcome Measures

Mean deviation (MD) in FDT visual fields as compared with standard HVF
Visual Field
Pattern standard deviation (PSD) in FDT visual fields as compared with standard HVF
Visual Field

Full Information

First Posted
July 18, 2016
Last Updated
October 28, 2020
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02862158
Brief Title
Frequency Doubling Technology (FDT) Mobile Visual Field Testing
Official Title
Evaluation of Different Frequency Doubling Technology (FDT) Mobile Devices for Visual Field Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
FDT visual field will be compared to standard HVF in detecting glaucomatous visual field loss
Intervention Type
Device
Intervention Name(s)
FDT visual field
Intervention Type
Device
Intervention Name(s)
Standard HVF
Primary Outcome Measure Information:
Title
Pattern of visual field loss in FDT visual fields as compared with standard HVF
Description
Visual Field
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.
Secondary Outcome Measure Information:
Title
Mean deviation (MD) in FDT visual fields as compared with standard HVF
Description
Visual Field
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.
Title
Pattern standard deviation (PSD) in FDT visual fields as compared with standard HVF
Description
Visual Field
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard K Lee, MD, PhD
Phone
305-326-6000
Email
rlee@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Lee, MD, PhD
Organizational Affiliation
University of Miami / Bascom Palmer Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard K Lee, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16225022
Citation
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.
Results Reference
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PubMed Identifier
24325017
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. doi: 10.7326/0003-4819-159-6-201309170-00686.
Results Reference
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PubMed Identifier
15741814
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. doi: 10.1097/01.ijg.0000151883.07232.54.
Results Reference
background
PubMed Identifier
19225357
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.
Results Reference
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Frequency Doubling Technology (FDT) Mobile Visual Field Testing

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