Glaucoma is characterized by irreversible vision loss through the progressive death of optic nerve fibers unless timely diagnosis and adequate treatment are provided. Medical therapy is aimed at lowering intraocular pressure (IOP) below a clinically determined target level in order to prevent or slow glaucoma progression. IOP is known to vary with the time of day as well as with daily activities. The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, allowing only snapshot and non-continuous measurements once per hour in the best cases. The procedure is cumbersome, expensive, inconvenient (disturbed sleep cycle as patient is awoken for nocturnal/sleep period measurements) and may not detect crucial IOP values in time. Sensimed AG has developed a new contact lens (CL)-based device intended to continuously measure IOP over 24 hours. The objective of this study is to investigate the use of device for 24-hour IOP monitoring in healthy subjects and glaucoma patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
9
[W]-Eye clinic
Poznan, Poland
Changes in IOP assessed by Goldfish following known physiological and induced changes in IOP
IOP will be measured using tonometry in the fellow eye and compared to IOP measured in the Goldfish eye with the Goldfish device
Time frame: 24 hours
Percentage of subjects completing 24-hour session with Goldfish
Percentage of subject completing the session will be calculated at the end of the study
Time frame: 24 hours
Wearing discomfort of Goldfish based on visual analogue scale
Tolerability of the Goldfish lens will be subjectively evaluated before and after GF wear using a visual analogue scale from 0 (no discomfort) to 100 (severe discomfort) mm
Time frame: 24 hours
Evaluation of Goldfish technical performance based on the percentage of valid Goldfish measurements
Percentage of valid measurement will be calculated at the end of each monitoring session
Time frame: 24 hours
Correlation between IOP and ocular pulse amplitude (OPA) assessed by Goldfish in the Goldfish eye and IOP and OPA measured by tonometry in the fellow eye
OPA will be extracted from the Goldfish signal in the Goldfish eye and measured by tonometry in the fellow eye. Both IOP and OPA measurement will be compared between fellow eyes
Time frame: 24 hours
Relationship between Goldfish IOP and blood pressure (BP) measurements over 24 hours
IOP signal acquired with Goldfish will be compared to BP signal assessed with a BP holter
Time frame: 24 hours
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