Participants will be patients in whom detection of vision impairment is important to trigger hospital visits for patient potential treatment with anti-VEGF with nAMD, DME, or RVO and with Best-Corrected Visual Acuity (BCVA) of 55 to 5 letters, inclusive (20/80 to 20/800 approximate Snellen equivalent) neovascular age-related macular degeneration (nAMD), diabetes macular edema (DME), retinal vein occlusion (RVO)
Conditions
Interventions
Patients will undergo a visual assessment by ETDRS, followed by Device (VA mode then CS mode), and repeat the visual assessments by using Device, followed by ETDRS.
Experimental Device
Vision Monitoring Device
Sponsors
Roche Thailand Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form 2. Ability to comply and willingness to undertake all scheduled visits and assessments, in the investigator's judgment. 3. Confirmed diagnosis of nAMD, DME, or RVO in the study eye prior to study entry 4. Have BCVA of 55 to 5 letters, inclusive, (20/80 to 20/800 approximate Snellen equivalent), using ETDRS chart at a starting distance of 4 meters on Day 1 5. Demonstrated response to current anti-VEGF intravitreal treatment and continued use of anti-VEGF with a planned schedule at least 1 visit within 6 months during the study 6. Ability to use a magnification tool such as a handheld or a digital magnifier on a regular basis, in the investigator's judgment. 7. Able to have access to the Internet at home
Exclusion criteria
Exclusion criteria: 1. Planned procedure or surgery during the study that affects stability in the patient vision, assessed by investigators 2. Any serious medical condition(s), in the investigator's judgment, precludes the subject's safe participation in and completion of the study (e.g. Epilepsy) 3. Any medical condition(s), in the investigator's judgment, that makes the use of the device very difficult and inconvenient such as manual dexterity, severe arthritis (to operate the remote control), vertigo, neck problems, and eye strains linked to screen watching 4. Use of any treatment(s), in the investigator's judgment, that makes the use of the device very difficult and inconvenient and/or precludes the subject's safe participation in and completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The usability of Device in daily life End of Study Number of hours using Device per patient per day and the most frequent types of daily activities using Device during study at the end of 6-month period | — |
Secondary
| Measure | Time frame |
|---|---|
| The agreement of high contrast VA using Device with clinic-based ETDRS chart at 4-meter distance End of Study Agreement between high contrast VA using Device and clinic-based ETDRS chart at a 4-meter distance,The repeatability of clinic-based Device, ETDRS End of Study Coefficient of Repeatability of clinic-based high contrast VA using Device at successive in-clinic visits | — |
Countries
Thailand
Contacts
Public ContactSansanee Lerdlitruangsin
Roche Thailand Ltd
Outcome results
None listed