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.
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).
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.
Parallel
Monitoring with contact lens sensor
DeviceMonitoring with contact lens sensor at 1-month pre-intervention visit
Monitoring with contact lens sensor
DeviceMonitoring with contact lens sensor at 1-month post-intervention visit
Monitoring with contact lens sensor
DeviceMonitoring with contact lens sensor at 3-months post-intervention visit
IOP-related fluctuation over a 24- hour period
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
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
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
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.
Click on the lead sponsor to view all of their trials.
Fundacio Privada Mon Clinic Barcelona
Lead sponsor
Glaukos Corporation
Collaborator
