A Prospective, Multi-Center Study to Assess the Usability and Clinical Performance of Digital Remote Eye-Health and Acuity Monitoring in Low-Vision Patients
- Conditions
- 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)
- Registration Number
- TCTR20221104003
- Lead Sponsor
- Roche Thailand Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 35
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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