A Prospective, Multi-Center Study to Assess the Usability and Clinical Performance of Digital Remote Eye-Health and Acuity Monitoring in Low-Vision Patients

Roche Thailand Ltd0 个研究点目标入组 35 人开始时间: 2022年11月4日最近更新: 2024年8月19日

试验速览

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•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

发起方

Roche Thailand Ltd