Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).
Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Subjects with normal macular thickness in one or both eyes. |
| |
| Group 2 | Subjects with center-involving macular edema due to wAMD in one or both eyes |
| |
| Group 3 | Subjects with center-involving macular edema due to DR or RVO in one or both eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RHMS-RTM | Device | Assessment of retinal thickness |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects aged ≥ 50 years old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marion Munk, MD, PhD | Inselspital, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital, University Hospital Bern, Department of Ophthalmology | Bern | 3010 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D008268 | Macular Degeneration |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
| SD-OCT | Diagnostic Test | Assessment of retinal structure |
|
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 |
| D013927 |
| Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |