Monitoring with contact lens sensorMonitoring with contact lens sensorMonitoring with contact lens sensor
Monitoring with contact lens sensor: Monitoring with contact lens sensor at 1-month pre-intervention visit
Monitoring with contact lens sensor: Monitoring with contact lens sensor at 1-month post-intervention visit
Monitoring with contact lens sensor: Monitoring with contact lens sensor at 3-months post-intervention visit
Study summary
The purpose of this study is to compare the IOP-related fluctuations using the CLS (contact lens sensor) Sensimed Triggerfish in glaucoma patients before and after glaucoma surgery with iStent inject W under physiological conditions and compare these results with a control group of glaucoma patients treated only with hypotensive medical treatment requiring cataract surgery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adult Patients (over 18 years old) with an initial diagnosis of POAG requiring an indication from the patient chart of an untreated IOP of over 21 mm Hg. Diagnosis of NTG requiring an untreated mean diurnal IOP of over 21 mm Hg from diagnosis to enrollment, indicated by the patient chart. Ocular hypertension is defined as a condition in which the IOP was greater than 21 mm Hg in the absence of glaucomatous defects in visual field testing, the normal appearance of the optic disc and nerve fiber layer, anatomic normality, open angles in gonioscopy, and the absence of ocular conditions contributing to the elevation of pressure, such as narrow angles, neovascular conditions, and uveitis.
* Adult Patients (over 18 years old ) diagnosed with POAG and NTG are defined as those with open normal appearing angles, typical glaucomatous optic atrophy (i.e., neural rim thinning, notching, saucerization, or nerve fiber layer disc haemorrhage), and typical glaucomatous visual field damage (i.e., arcuate, paracentral scotoma, or nasal step).
* Adult Patients (age over 18 years old ):
with unilateral or bilateral open-angle glaucoma (POAG) without previous eye surgery, treated with topical anti-glaucoma medications, who need glaucoma surgery with iStent inject W. The investigators will include patients with isolate iStent surgery and patients with combined cataract and iStent surgery. In cases of bilateral glaucoma, the two eyes of the same patient may be included consecutively.
For the control group only: Patients with topical hypotensive glaucoma treatment requiring cataract surgery.
Exclusion Criteria:
* Age under 18 years
* Visual defects attributable to nonglaucomatous conditions, primary angle closure glaucoma, neovascular glaucoma, history of ocular trauma, retinal disease or ocular inflammation, and laser therapy or secondary glaucoma.
* The patients have to meet best-corrected Snellen visual acuity of under 0.3 and spherical equivalent of under 6 diopter.
* We will not include patients with previous ocular surgery, except cataract surgery performed at least 6 months prior to the inclusion date.
Primary outcome measure(s)
IOP-related fluctuation over a 24- hour period — 24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit The amplitude of the cosine curve is a parameter based on the cosine model fitted to the CLS data. The amplitude is the difference between the maximum and minimum values of the cosine-fit curve divided by 2. This is an overall estimate of the magnitude of signal oscillation during the tested period. The cosinor model represents the actual amplitude of IOP-related fluctuation over a 24- hour period and is most representative of IOP-related changes.
IOP-related fluctuations will be calculated based on the GAT IOP measured at baseline and at each visit during the study.
Control group will not be monitored in the 1-month visit.
CLS increase and decrease rates — 24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit CLS (Contact Lens Sensor) increase and decrease rates (change in CLS units/ change in time): maximum
Control group will not be monitored in the 1-month visit.
CLS increase and decrease rates — 24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit CLS (Contact Lens Sensor) increase and decrease rates (change in CLS units/ change in time): minimum.
Control group will not be monitored in the 1-month visit.
CLS increase and decrease rates — 24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit CLS (Contact Lens Sensor) increase and decrease rates (change in CLS units/ change in time): median.
Control group will not be monitored in the 1-month visit.
CLS increase and decrease rates — 24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit CLS (Contact Lens Sensor) increase and decrease rates (change in CLS units/ change in time): mean.
Control group will not be monitored in the 1-month visit.
Sleep-to-wake slope — 24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit Calculation of sleep-to-wake slope.
Control group will not be monitored in the 1-month visit.
Wake-to-sleep slope — 24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit Calculation of wake-to-sleep slope.
Control group will not be monitored in the 1-month visit.
Number of peaks of IOP-related fluctuations — 24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit Number of peaks: over 24 hours, inferior to 30 minutes, superior to 90mVeq.
Control group will not be monitored in the 1-month visit.
Trial sites (2)
Facility
City
Region
Status
Institut Català de Retina
Barcelona
Spain
Recruiting
Hospital Clínic de Barcelona
Barcelona
Spain
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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