Macular EdemaNCT04499703
Evaluation of the Retinal Health Monitoring System Thickness Module
An observational study of Macular Edema and Macular Degeneration, run by Kubota Vision Inc. at 1 site in Switzerland.
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 50 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
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2020to 25 Jan 2021
- 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 old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.
Who may be able to join
- Age ≥50.
- Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)
- Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)
- Able to perform self-testing of retinal thickness with the RHMS-RTM after training
- Able and willing to provide written informed consent before undergoing any study-related procedures
- Group 1: Macula with normal thickness [central subfield thickness (CST): <305μm in women, and <320μm in men as measured by Heidelberg Spectralis SD-OCT in at least one eye. Patients diagnosed with dry AMD are eligible for enrollment into Group 1. No history of wAMD, DR, or RVO in either eye
- Group 2 and Group 3, in at least one and the same eye: History of center-involving macular edema due to wAMD (Group 2); or DR or RVO (Group 3); Macular edema on SD-OCT with CST ≥305 μm in women, and ≥320μm in men as measured by Heidelberg Spectralis SD-OCT.
Who cannot join
- History of corneal refractive surgery [e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), radial keratotomy (RK)] in the study eye(s)
- 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 of screening or an investigational device within 60 days of screening
- Refractive error within defined limits
- 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.
Switzerland1 site
Inselspital, University Hospital Bern, Department of Ophthalmology
Bern, 3010
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
- Age-Related Macular Degeneration, macular edema, retinal vein occlusion, diabetic macular edema
- Medical subject headings
- Macular Edema, Macular Degeneration, 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 wAMD 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
Secondary outcomes (3)
Repeatability of RHMS-RTM retina thickness measurements
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 day
Intraretinal and subretinal fluid detection
To evaluate the feasibility of intra- and sub-retinal fluid detection
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 posted5 Aug 2020
- Study start11 Nov 2020
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubota Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marion Munk, MD, PhD, Principal investigator, Inselspital, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499703
- Sponsor's protocol ID
- SCT-202 D
- Status last verified
- Feb 2021
- First submitted
- 31 Jul 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 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
- NCT04499703
- Acronym / sponsor ID
- SCT-202 D
- Conditions
- Macular Edema, Macular Degeneration
- Keywords
- Age-Related Macular Degeneration, macular edema, retinal vein occlusion, diabetic macular edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 5 Aug 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 wAMD 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
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged ≥ 50 years old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.
Key inclusion criteria (7 listed)
- Age ≥50.
- Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)
- Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)
- Able to perform self-testing of retinal thickness with the RHMS-RTM after training
- Able and willing to provide written informed consent before undergoing any study-related procedures
Key exclusion criteria (5 listed)
- History of corneal refractive surgery [e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), radial keratotomy (RK)] in the study eye(s)
- 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 of screening or an investigational device within 60 days of screening
- Refractive error within defined limits
- 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
3 secondary outcomes
Repeatability of RHMS-RTM retina thickness measurements
Time frame: 1 day
Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT
Time frame: 1 day
Intraretinal and subretinal fluid detection
Time frame: 1 day
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 18 Feb 2021.
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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.
Marion Munk, MD, PhD principal investigator
Inselspital, University Hospital Bern
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 Switzerland.
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 7 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: finished, as of the sponsor's last update on 18 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 Switzerland. 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?
Evaluation of the RHMS-RTM retinal thickness measurements (time frame: 1 day). 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 18 Feb 2021.