Purpose
To determine the safety, tolerability, and reproducibility of intraocular pressure (IOP) patterns during repeated continuous 24-hour IOP monitoring with a telemetric contact-lens sensor (CLS).
Design
Prospective clinical trial.
Participants
Forty patients with suspect (n=21) or established glaucoma (n=19).
Methods
Patients participated in two 24-hour IOP monitoring sessions (S1 and S2) at a 1-week interval using the SENSIMED Triggerfish CLS (Sensimed AG, Switzerland). Patients pursued daily activities and sleep behavior was not controlled. The recordings were analyzed for differences between daytime and nighttime data and for reproducibility of signal patterns between the 2 sessions. Pearson correlations were obtained by pairing intervals across sessions.
Main Outcome Measures
Adverse events (AE), tolerability using the visual analogue score (VAS), and reproducibility of IOP patterns.
Results
Mean age was 55.5 ± 15.7 years and 60.0% were male. Main AEs were blurred vision (82.5%), conjunctival hyperemia (80.0%), and superficial punctate keratitis (15.0%). Patients reported a mean VAS of 27.2 ± 18.5 (S1) and 23.8 ± 18.7 (S2) (P = 0.216). Positive linear slopes of the sensor signal from the wake to the sleep period were detected for the ‘no glaucoma medication’ group (slope: 0.14 ± 0.15, p < 0.01, S1; slope: 0.12 ± 0.17, p = 0.03, S2) and for the ‘glaucoma medication’ group (slope: 0.03 ± 0.24, p = 0.52, S1; slope: 0.11 ± 0.16, p = 0.02, S2). Overall correlation between the two sessions was 0.59 (0.51 ‘no glaucoma medication’; 0.63 ‘glaucoma medication’) (P = 0.117).
Conclusions
Repeated use of the CLS demonstrated good safety and tolerability. The recorded IOP patterns showed fair reproducibility, suggesting that data from 24-h continuous IOP monitoring may be useful in the management of glaucoma patients.