Abstract
Purpose: :
To determine the safety, tolerability, and short-term reproducibility of intraocular pressure (IOP) patterns during repeated continuous 24-hour IOP monitoring in glaucoma patients and suspects.
Methods: :
Forty glaucoma suspect (n=21) or established glaucoma (n=19) patients underwent ambulatory 24-hour IOP monitoring on two visits at one-week interval using the SENSIMED Triggerfish ocular telemetry sensor (Sensimed AG, Switzerland). Patients pursued their normal daily activities and their sleep behavior was not controlled. Ocular discomfort was assessed using the Visual Analogue Scale (VAS), ranging from 0 (no discomfort) to 100 (very severe discomfort). The continuous recordings were analyzed for differences between daytime and nighttime data and for reproducibility of signal patterns between the 2 sessions. Pearson correlation was computed between sensor outputs in each session for each patient separately. Correlations were obtained by pairing intervals across sessions.
Results: :
Average age of patients was 64.0±16.2 years, 60.0% were male. 67.5% of patients were under topical IOP-lowering medication. No serious adverse events occurred. The most frequent adverse event was blurred vision (82.5%), followed by conjunctival hyperemia (80.0%), and superficial punctate keratitis (15.0%). 95% of all adverse events were graded as mild. On average, patients reported a VAS of 27.2 (session 1) and 23.0 (session 2) (P=0.54). Complete data from both sessions were available from 34 patients. 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, p<0.01, session 1; slope: 0.12, p=0.03, session 2) and for the ‘glaucoma medication’ group (slope: 0.03, p=0.51, session 1; slope: 0.11, p<0.01, session 2), indicating a possible medication effect on the nighttime IOP rise. The overall correlation (r) between the two 24-hour IOP monitoring sessions was 0.59 (0.51 no medication group; 0.63 medication group).
Conclusions: :
Repeated use of the contact-lens based ocular telemetry sensor demonstrated good safety and tolerability. It also showed fair reproducibility of IOP patterns in glaucoma patients and suspects. Treated patients showed flattening of the nocturnal IOP rise. These findings suggest that data from 24-h continuous IOP monitoring may be useful for the management of glaucoma patients.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01319617
Keywords: intraocular pressure • circadian rhythms