Remote Monitoring of Visual Function in Patients with Maculopathy: The Aphelion Study.

Area of Science:

• Ophthalmology
• Medical Technology
• Digital Health

Background:

• Remote monitoring of vision aids in detecting disease activity in maculopathy patients.
• The shape discrimination hyperacuity (SDH) test is a key tool for remote vision assessment.
• Evaluating novel self-testing tools is crucial for expanding remote patient monitoring capabilities.

Purpose of the Study:

• To determine the in-clinic accuracy and repeatability of three myVisionTrack expanded version (mVTx) self-testing devices.
• To assess the usability and performance of mVTx tests for visual acuity (VA) and contrast sensitivity.
• To compare the mVTx tests against standard clinical vision tests.

Main Methods:

• A prospective, single-arm study (Aphelion) included 122 adults with maculopathy at two US sites.
• Participants performed mVTx tests (tumbling E, Landolt C, contrast sensitivity, SDH) and standard clinical tests.
• Bland-Altman analyses assessed test-retest repeatability and agreement between mVTx and clinical tests; a usability survey was also administered.

Main Results:

• The mVTx tests demonstrated good repeatability, with 95% limits of agreement (LoA) ranging from ±0.18 to ±0.32 logMAR/logCT.
• Agreement with standard clinical tests was acceptable, with LoA for VA tests between ±0.35 to ±0.39 logMAR and contrast sensitivity at ±0.30 logCT.
• Most participants (85%) found the tests easy to learn, with the tumbling E test being the most user-friendly.

Conclusions:

• The mVTx visual acuity tests are accurate and repeatable, validating their use in remote monitoring.
• These self-testing tools show promise for detecting maculopathy progression between clinical appointments.
• The mVTx tests, alongside the SDH test, can enhance remote patient management for individuals with maculopathy.