Evaluation of the Retinal Health Monitoring System Thickness Module

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

Detailed Description
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Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.

Official Title
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Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in Subjects With Normal Macular Thickness and Subjects With Center-involving Macular Edema

Conditions
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Macular Edema, Macular Degeneration

Intervention / Treatment
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* Device: RHMS-RTM
* Diagnostic Test: SD-OCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Subjects with normal macular thickness in one or both eyes. | Device: RHMS-RTM<br>* Assessment of retinal thickness<br>* Other names: Handheld swept source (SS) optical coherence tomography (OCT);Diagnostic Test: SD-OCT<br>* Assessment of retinal structure<br>|
| Group 2<br>Subjects with center-involving macular edema due to wAMD in one or both eyes | Device: RHMS-RTM<br>* Assessment of retinal thickness<br>* Other names: Handheld swept source (SS) optical coherence tomography (OCT);Diagnostic Test: SD-OCT<br>* Assessment of retinal structure<br>|
| Group 3<br>Subjects with center-involving macular edema due to DR or RVO in one or both eyes | Device: RHMS-RTM<br>* Assessment of retinal thickness<br>* Other names: Handheld swept source (SS) optical coherence tomography (OCT);Diagnostic Test: SD-OCT<br>* Assessment of retinal structure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the RHMS-RTM retinal thickness measurements | To evaluate the ability of the RHMS-RTM device to measure retinal thickness | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability of RHMS-RTM retina thickness measurements | 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 day | 
| Intraretinal and subretinal fluid detection | To evaluate the feasibility of intra- and sub-retinal fluid detection | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-Related Macular Degeneration, macular edema, retinal vein occlusion, diabetic macular edema