NCT04428242

Brief Summary

Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

June 9, 2020

Last Update Submit

February 18, 2021

Conditions

Macular EdemaMacular Degeneration

Keywords

Macular Edema, Wet AMDRetinal ThicknessDiabetic Retinopathy, Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (3)

  • Evaluation of the RHMS-RTM retinal thickness measurements

    To evaluate the ability of the RHMS-RTM device to measure retinal thickness

    1 day

  • RHMS-RTM repeatability

    To assess repeatability of the RHMS-RTM device

    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

    1 month

Study Arms (3)

Group 1

Subjects with normal macular thickness in one or both eyes.

Device: RHMS-RTMDiagnostic Test: SD-OCT

Group 2

Subjects with center-involving macular edema due to w/AMD in one or both eyes.

Device: RHMS-RTMDiagnostic Test: SD-OCT

Group 3

Subjects with center-involving macular edema due to DR or RVO in one or both eyes.

Device: RHMS-RTMDiagnostic Test: SD-OCT

Interventions

RHMS-RTMDEVICE

Assessment of retinal thickness.

Also known as: Handheld swept source (SS) optical coherence tomography (OCT)
Group 1Group 2Group 3
SD-OCTDIAGNOSTIC_TEST

Assessment of retinal structure.

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects aged ≥ 18 years old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retinal Consultants Medical Group, Inc

Sacramento, California, 95819, United States

Location

MeSH Terms

Conditions

Macular EdemaMacular DegenerationDiabetic RetinopathyRetinal Vein Occlusion

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesVenous ThrombosisThrombosisEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Jeff Gregory, MD

    Kubota Vision Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 11, 2020

Study Start

April 1, 2020

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

US(1)