Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma.
(Clinical Trial;Journal Article)
OBJECTIVE: To examine the safety, tolerability, and reproducibility of intraocular pressure (IOP) patterns during repeated continuous 24-hour IOP monitoring with a contact lens sensor. METHODS: Forty patients suspected of having glaucoma(n=21) or with established glaucoma (n=19) were studied.Patients participated in two 24-hour IOP monitoring sessions (S1 and S2) at a 1-week interval (SENSIMED Triggerfish CLS; Sensimed AG). Patients pursued daily activities,and sleep behavior was not controlled. Incidence of adverse events and tolerability (visual analog scale score)were assessed. Reproducibility of signal patterns was assessed using Pearson correlations. RESULTS: The mean (SD) age of the patients was 55.5(15.7) years, and 60% were male. Main adverse events were blurred vision (82%), conjunctival hyperemia (80%),and superficial punctate keratitis (15%). The mean (SD)visual analog scale score was 27.2(18.5) mm in S1 and 23.8(18.7) mm in S2 (P=.22). Overall correlation between the 2 sessions was 0.59 (0.51 for no glaucoma medication and 0.63 for glaucoma medication) (P=.12). Mean(SD) positive linear slopes of the sensor signal from wake to 2 hours into sleep were detected in both sessions for the no glaucoma medication group (S1: 0.40 [0.34],P.001; S2: 0.33[0.30], P.01) but not for the glaucoma medication group (S1: 0.24 [0.60], P=.06; S2:0.40[0.40], P.001). CONCLUSIONS: Repeated use of the contact lens sensor demonstrated good safety and tolerability. The recorded IOP patterns showed fair to good reproducibility,suggesting that data from continuous 24-hour IOP monitoring may be useful in the management of patients with glaucoma. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01319617
Mansouri, K; Medeiros, FA; Tafreshi, A; Weinreb, RN
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