Changes in Eye Pressure in Glaucoma Patients Treated with Istent Inject W, Monitored by a Contact Lens Sensor

ConditionGlaucoma Eye
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacio Privada Mon Clinic Barcelona

About this trial

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 criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Monitoring with contact lens sensor
  • Monitoring with contact lens sensor
  • Monitoring with contact lens sensor

Treatment groups

53 Participants
are divided into 2 treatment groups

Sponsors and collaborators