Background/Aims This study assessed the feasibility of a novel contact lens device for intraocular pressure (IOP) and ocular pulse amplitude (OPA) continuous measurements over 24 hours.
Methods This prospective, open-label, single-centre, non-randomised study included glaucoma and healthy subjects. IOP and OPA values acquired by the pressure-measuring contact lens (PMCL) device in one patient’s eye at the beginning of the measurement were compared with tonometry values (Goldman applanation tonometry (GAT) and dynamic contour tonometry (DCT)) in the same eye just before PMCL placement. Furthermore, IOP and OPA values measured with PMCL on the study eye during a water drinking test (WDT) were compared with DCT values in the fellow eye. Comparisons were performed using t-tests with 95% Confidence Intervals.
Results Twenty-four-hour IOP and OPA curves were obtained for eight subjects. The mean IOP difference between PMCL and tonometry on the same eye was within ±5 mm Hg in 75% (GAT) and 87.5% (DCT) of subjects. IOP variations due to WDT were detected by PMCL and DCT, showing an average increase of 2.43 and 1.85 mm Hg, respectively. Differences between PMCL and DCT for IOP variations in fellow eyes were within ±5 mm Hg for 97.2% of time points. The difference between OPA in fellow eyes was within ±5 mm Hg for 85.5% of the time points.
Conclusions This first-in-human study is a proof-of-concept for 24-hour continuous measurements of IOP and OPA with the PMCL. This device is non-invasive and has good comparability with standard tonometry.
- intraocular pressure
- clinical trial
- contact lens
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Contributors RW: conducted the present study; also contributed to the interpretation of the results and the draft of the manuscript. TV: contributed to the design, analysis, interpretation of the results and the draft of the manuscript. SS-Z: contributed to the conception and design of the present study, the interpretation of the results and the draft of the manuscript. MS: contributed to the design, interpretation of the results and the draft of the manuscript. SC: contributed to the conception, analysis, interpretation of the results and the draft of the manuscript. KM: contributed to the conception and design of the present study, the interpretation of the results and the draft of the manuscript. All authors approved the final version of the manuscript and are accountable for all aspects of this work.
Funding This study was supported by Sensimed AG.
Competing interests TV, SS-Z, MS and SC are employees of Sensimed. KM is a consultant for Sensimed.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon request. Deidentified participant data (case report forms), protocol, statistical analysis plan and report are available at the Sponsor and can be obtained upon reasonable request.
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