Age Related Macular DegenerationNCT04169802
Study Evaluating Retinal Health Monitoring System Visual Acuity Module.
An observational study of Age Related Macular Degeneration, run by Kubota Vision Inc. at 1 site in United States.
Trial summary
Assess the performance and usability of the RHMS Visual Acuity Module. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Retinal Health Monitoring System Visual Acuity Module and Sloan letter, logarithmic near visual acuity chart (Reference Chart)
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 15 Apr 2020
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects aged ≥ 50 years, with a normal central macula or with neovascular AMD
Who may be able to join
- Cohort 1 - Normal subjects
- Age ≥ 50 years
- Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye
- Able to perform self-testing with the Visual Acuity Module of the RHMS after training
- Able and willing to give informed consent
- Cohort 2 - Subjects with neovascular AMD
Show all 9Show fewer
- Age ≥ 50 years
- History of neovascular age-related macular degeneration, in the study eye
- Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye
Who cannot join
- Cohort 1 - Normal subjects
- History of ophthalmic disease resulting in decrease in visual acuity per the Investigator, in the study eye
- Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days
- Cohort 2 - Subjects with neovascular AMD
- History of geographic atrophy or macular atrophy within the central 3 mm of the macula, in the study eye
- History of macular hole in the study eye
- Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Consultants of Arizona
Phoenix, Arizona, 85053
About this study
Official title: An Observational, Non-Significant Risk Study Of The Retinal Health Monitoring System (RHMS) - Visual Acuity Module - In Normal Patients And Patients With Neovascular Age-Related Macular Degeneration (AMD)
Assess the performance and usability of the RHMS Visual Acuity Module.
Read the detailed description
This 510(k)-enabling study is designed to assess the performance and usability of the RHMS Visual Acuity Module in normal patients and patients with neovascular AMD.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Retinal Health Monitoring System Visual Acuity Module, Sloan letter, logarithmic near visual acuity chart (Reference Chart)
- Keywords
- Age-Related Macular Degeneration, visual acuity
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal Health Monitoring System Visual Acuity ModuleDiagnostic test
Assessment of corrected near visual acuity
Sloan letter, logarithmic near visual acuity chart (Reference Chart)Diagnostic test
Assessment of corrected near visual acuity
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Age ≥ 50 years, Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye. Receives: Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module; Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart) | |
| Subjects with neovascular AMD | Age ≥ 50 years, History of neovascular age-related macular degeneration, in the study eye, Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye. Receives: Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module; Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the repeatability of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
To determine the precision (repeatability and reproducibility) of corrected near visual acuity (CNVA) measured by the RHMS Visual Acuity Module and an in-clinic, near logarithmic Sloan Letter chart (Reference Chart).
Measured: 1 day
Comparison of the reproducibility of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
To evaluate the agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
Measured: 1 day
Agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
To evaluate the usability of the RHMS Visual Acuity Module
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start20 Nov 2019
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubota Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Gregory, MD, Study director, Kubota Vision Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169802
- Sponsor's protocol ID
- SCT-201
- Status last verified
- Feb 2021
- First submitted
- 17 Nov 2019
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Non-Significant Risk Study Of The Retinal Health Monitoring System (RHMS) - Visual Acuity Module - In Normal Patients And Patients With Neovascular Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT04169802
- Acronym / sponsor ID
- SCT-201
- Conditions
- Age Related Macular Degeneration
- Keywords
- Age-Related Macular Degeneration, visual acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- 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.
Assess the performance and usability of the RHMS Visual Acuity Module.
Detailed description
This 510(k)-enabling study is designed to assess the performance and usability of the RHMS Visual Acuity Module in normal patients and patients with neovascular AMD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | – | Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module, Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart)Age ≥ 50 years, Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye. |
| Subjects with neovascular AMD | – | Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module, Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart)Age ≥ 50 years, History of neovascular age-related macular degeneration, in the study eye, Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged ≥ 50 years, with a normal central macula or with neovascular AMD
Key inclusion criteria (9 listed)
- Cohort 1 - Normal subjects
- Age ≥ 50 years
- Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye
- Able to perform self-testing with the Visual Acuity Module of the RHMS after training
- Able and willing to give informed consent
Key exclusion criteria (7 listed)
- Cohort 1 - Normal subjects
- History of ophthalmic disease resulting in decrease in visual acuity per the Investigator, in the study eye
- Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days
- Cohort 2 - Subjects with neovascular AMD
- History of geographic atrophy or macular atrophy within the central 3 mm of the macula, in the study eye
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 |
|---|---|---|
| Retinal Health Monitoring System Visual Acuity ModuleAssessment of corrected near visual acuity | Diagnostic test | Normal subjects, Subjects with neovascular AMD |
| Sloan letter, logarithmic near visual acuity chart (Reference Chart)Assessment of corrected near visual acuity | Diagnostic test | Normal subjects, Subjects with neovascular AMD |
Primary outcome
Comparison of the repeatability of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
Time frame: 1 day
To determine the precision (repeatability and reproducibility) of corrected near visual acuity (CNVA) measured by the RHMS Visual Acuity Module and an in-clinic, near logarithmic Sloan Letter chart (Reference Chart).
Comparison of the reproducibility of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
Time frame: 1 day
To evaluate the agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
Agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
Time frame: 1 day
To evaluate the usability of the RHMS Visual Acuity Module
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Jeff Gregory, MD study director
Kubota Vision Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by Kubota Vision Inc. 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 21 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the repeatability of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2021.