On the Feasibility of Accelerating Glaucoma Clinical Trials Using Portable Perimetry.

Area of Science:

• Ophthalmology
• Clinical Trials
• Medical Devices

Background:

• Glaucoma progression is typically monitored using in-clinic visual field (VF) tests.
• Portable, home-based perimetry offers potential for more frequent monitoring.
• Assessing the utility of home perimetry in detecting glaucoma progression is crucial for clinical trial design.

Purpose of the Study:

• To model the effectiveness of frequent (weekly, monthly) home visual field assessments in detecting glaucoma progression within a clinical trial setting.
• To compare the performance of portable perimetry against standard in-clinic devices for glaucoma progression detection.
• To evaluate the impact of home perimetry on clinical trial sample size requirements.

Main Methods:

• A cross-sectional study with simulations involving 40 patients (78 eyes) with varying glaucoma status.
• Participants underwent both portable (Eyecatcher v3.0; EC3) and reference (HFA SITA-Fast) visual field tests.
• Linear mixed modeling was used to predict the proportion of progressors detected under different testing frequencies and variability levels.

Main Results:

• The portable perimeter (EC3) showed lower reliability (CoRMD95% = 6.37 dB) compared to the reference device (HFA; 4.25 dB).
• Simulations indicated that monthly EC3 testing could detect a higher proportion of progressors than quarterly HFA testing.
• Frequent home testing (monthly/fortnightly) could decrease required clinical trial sample sizes by 24.3%/36.3% for detecting a 20% reduction in progression.

Conclusions:

• Home visual field assessments, despite lower device reliability, enable faster and greater detection of glaucoma progression through increased testing frequency.
• The use of home perimetry in clinical trials may significantly reduce the number of participants needed.
• Further considerations regarding duration, access, and cost-effectiveness of home-based glaucoma monitoring are warranted.