Evaluation of the Retinal Health Monitoring System Thickness Module

February 16, 2021 updated by: Kubota Vision Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, University Hospital Bern, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects aged ≥ 50 years old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.

Description

Inclusion Criteria:

  1. Age ≥50.
  2. Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)
  3. Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)
  4. Able to perform self-testing of retinal thickness with the RHMS-RTM after training
  5. Able and willing to provide written informed consent before undergoing any study-related procedures
  6. 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
  7. 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.

Exclusion Criteria:

  1. History of corneal refractive surgery [e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), radial keratotomy (RK)] in the study eye(s)
  2. History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
  3. Participation in any study using an investigational drug within 30 days of screening or an investigational device within 60 days of screening
  4. Refractive error within defined limits
  5. History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Subjects with normal macular thickness in one or both eyes.
Device: RHMS-RTM
Assessment of retinal thickness
Other Names:
  • Handheld swept source (SS) optical coherence tomography (OCT)
Diagnostic test: SD-OCT
Assessment of retinal structure
Group 2
Subjects with center-involving macular edema due to wAMD in one or both eyes
Device: RHMS-RTM
Assessment of retinal thickness
Other Names:
  • Handheld swept source (SS) optical coherence tomography (OCT)
Diagnostic test: SD-OCT
Assessment of retinal structure
Group 3
Subjects with center-involving macular edema due to DR or RVO in one or both eyes
Device: RHMS-RTM
Assessment of retinal thickness
Other Names:
  • Handheld swept source (SS) optical coherence tomography (OCT)
Diagnostic test: SD-OCT
Assessment of retinal structure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Repeatability of RHMS-RTM retina thickness measurements
Time Frame: 1 day
To assess repeatability of the RHMS-RTM device
1 day
Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT
Time Frame: 1 day
To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT
1 day
Intraretinal and subretinal fluid detection
Time Frame: 1 day
To evaluate the feasibility of intra- and sub-retinal fluid detection
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kubota Vision Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marion Munk, MD, PhD, Inselspital, University Hospital Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCT-202 D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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