GlaucomaNCT02862158
Frequency Doubling Technology (FDT) Mobile Visual Field Testing
A study testing FDT visual field and Standard HVF in people with Glaucoma, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- FDT visual field and Standard HVF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine
Miami, Florida, 33136
Richard K Lee, MD, PhD
About this study
Official title: Evaluation of Different Frequency Doubling Technology (FDT) Mobile Devices for Visual Field Assessment
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- FDT visual field, Standard HVF
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDT visual fieldDevice
Standard HVFDevice
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | FDT visual field will be compared to standard HVF in detecting glaucomatous visual field loss Receives: Device: FDT visual field; Device: Standard HVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of visual field loss in FDT visual fields as compared with standard HVF
Visual Field
Measured: 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
Visual Field
Measured: 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
Visual Field
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard K. Lee, University of Miami
- Investigators
- Richard Lee, MD, PhD, Principal investigator, University of Miami / Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862158
- Sponsor's protocol ID
- 20150968
- Status last verified
- Oct 2020
- First submitted
- 18 Jul 2016
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 16225022Moyer 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.
PubMed 24325017Mansberger 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.
PubMed 15741814Nomoto 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.
PubMed 19225357
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Frequency Doubling Technology (FDT) Mobile Devices for Visual Field Assessment
- ClinicalTrials.gov ID
- NCT02862158
- Acronym / sponsor ID
- 20150968
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: FDT visual field, Device: Standard HVFFDT visual field will be compared to standard HVF in detecting glaucomatous visual field loss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDT visual field | Device | Experimental |
| Standard HVF | Device | Experimental |
Primary outcome
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
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Background: PubMed 16225022Guirguis-Blake J. Rationale for the USPSTF recommendation on screening for glaucoma. Am Fam Physician. 2005 Oct 1;72(7):1184, 1187. No abstract available.
- Background: PubMed 24325017Moyer 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.
- Background: PubMed 15741814Mansberger 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.
- Background: PubMed 19225357Nomoto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Lee, MD, PhD principal investigator
University of Miami / Bascom Palmer Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDT visual field and Standard HVF in people with Glaucoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard K Lee, MD, PhD (305-326-6000, rlee@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862158, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.