Macular EdemaNCT04428242
Study Evaluating Retinal Health Monitoring System Thickness Module
An observational study of Macular Edema and Macular Degeneration, run by Kubota Vision Inc. at 1 site in United States.
Trial summary
Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Edema, Macular Degeneration
- What is being tested?
- RHMS-RTM and SD-OCT
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2020to Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects aged ≥ 18 years old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.
Who may be able to join
- Corrected visual acuity (VA) of 20/100 or better, in the study eye(s)
- Media clarity, undilated pupil size, OCT-B scans, axial length measurements in the study eye(s)
- Able to perform self-testing of retinal thickness with the RHMS-RTM after training
- Able and willing to give informed consent
- Group 1:
- Macula with normal thickness [central subfield thickness (CST) below 305 microns as measured by SD-OCT] in at least one eye
Show all 11Show fewer
- Patients with dry AMD are eligible for enrollment into Group 1
- No history of wet AMD, DR, or RVO in either eye
- Group 2 and Group 3 (in at least one or the same eye):
- History of center-involving macular edema due to wet AMD (Group 2); or DR or RVO (Group 3)
- Macular edema on SD-OCT with CST ≥ 305 microns
Who cannot join
- History of corneal refractive surgery, photorefractive keratectomy, radial keratotomy, in the study eye
- History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
- Participation in any study using an investigational drug within 30 days or screening or investigational device within 60 days of screening
- Refractive error: spherical equivalent of > 3 diopters of hyperopia or > 6 diopters of myopia, or > 2 diopters cylinder in the study eye(s)
- History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)
Trial locations and contacts
1 site in 1 country.
United States1 site
Retinal Consultants Medical Group, Inc
Sacramento, California, 95819
About this study
Official title: Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in Subjects With Normal Macular Thickness and Subjects With Center-involving Macular Edema
Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).
Read the detailed description
Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.
- Conditions
- Macular Edema, Macular Degeneration
- Being tested
- RHMS-RTM, SD-OCT
- Keywords
- Macular Edema, Wet AMD, Retinal Thickness, Diabetic Retinopathy, Retinal Vein Occlusion
- Medical subject headings
- Macular Edema, Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHMS-RTMDevice
Also called Handheld swept source (SS) optical coherence tomography (OCT)
Assessment of retinal thickness.
SD-OCTDiagnostic test
Assessment of retinal structure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Subjects with normal macular thickness in one or both eyes. Receives: Device: RHMS-RTM; Diagnostic Test: SD-OCT | |
| Group 2 | Subjects with center-involving macular edema due to w/AMD in one or both eyes. Receives: Device: RHMS-RTM; Diagnostic Test: SD-OCT | |
| Group 3 | Subjects with center-involving macular edema due to DR or RVO in one or both eyes. Receives: Device: RHMS-RTM; Diagnostic Test: SD-OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the RHMS-RTM retinal thickness measurements
To evaluate the ability of the RHMS-RTM device to measure retinal thickness
Measured: 1 day
RHMS-RTM repeatability
To assess repeatability of the RHMS-RTM device
Measured: 1 day
Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT
To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study startApr 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: COVD-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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
- Prospective
- Enrolment
- 0 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
- NCT04428242
- Sponsor's protocol ID
- SCT-202
- Status last verified
- Feb 2021
- First submitted
- 9 Jun 2020
- 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
- Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in Subjects With Normal Macular Thickness and Subjects With Center-involving Macular Edema
- ClinicalTrials.gov ID
- NCT04428242
- Acronym / sponsor ID
- SCT-202
- Conditions
- Macular Edema, Macular Degeneration
- Keywords
- Macular Edema, Wet AMD, Retinal Thickness, Diabetic Retinopathy, Retinal Vein Occlusion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVD-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 11 Jun 2020 (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.
Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).
Detailed description
Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: RHMS-RTM, Diagnostic Test: SD-OCTSubjects with normal macular thickness in one or both eyes. |
| Group 2 | – | Device: RHMS-RTM, Diagnostic Test: SD-OCTSubjects with center-involving macular edema due to w/AMD in one or both eyes. |
| Group 3 | – | Device: RHMS-RTM, Diagnostic Test: SD-OCTSubjects with center-involving macular edema due to DR or RVO in one or both eyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged ≥ 18 years old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.
Key inclusion criteria (11 listed)
- Corrected visual acuity (VA) of 20/100 or better, in the study eye(s)
- Media clarity, undilated pupil size, OCT-B scans, axial length measurements in the study eye(s)
- Able to perform self-testing of retinal thickness with the RHMS-RTM after training
- Able and willing to give informed consent
- Group 1:
Key exclusion criteria (5 listed)
- History of corneal refractive surgery, photorefractive keratectomy, radial keratotomy, in the study eye
- History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
- Participation in any study using an investigational drug within 30 days or screening or investigational device within 60 days of screening
- Refractive error: spherical equivalent of > 3 diopters of hyperopia or > 6 diopters of myopia, or > 2 diopters cylinder in the study eye(s)
- History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)
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 |
|---|---|---|
| RHMS-RTMAlso: Handheld swept source (SS) optical coherence tomography (OCT)Assessment of retinal thickness. | Device | Group 1, Group 2, Group 3 |
| SD-OCTAssessment of retinal structure. | Diagnostic test | Group 1, Group 2, Group 3 |
Primary outcome
Evaluation of the RHMS-RTM retinal thickness measurements
Time frame: 1 day
To evaluate the ability of the RHMS-RTM device to measure retinal thickness
RHMS-RTM repeatability
Time frame: 1 day
To assess repeatability of the RHMS-RTM device
Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT
Time frame: 1 month
To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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 Macular Edema and 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 11 inclusion and 5 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of the RHMS-RTM retinal thickness measurements (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.