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NCT06607705Recruiting

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

Fluctuations of the Intraocular Pressure in Surgically Treated Glaucoma Patients with IStent Inject W by a Contact Lens Sensor

Source: ClinicalTrials.gov · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
53 (estimated)
First submitted
16 Sept 2024
Start date
21 Oct 2024
Primary completion date
1 Oct 2025
Lead sponsor
Fundacio Privada Mon Clinic Barcelona
Diseases
Glaucoma
NCT number
NCT06607705

What you commit to

  • Study type: Interventional
  • Planned participants: 53
  • From 21 Oct 2024 to the primary completion date, 1 Oct 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • We will not include patients with previous ocular surgery, except cataract surgery performed at least 6 months prior to the inclusion date.

Other illness

  • 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.

Age

  • Age under 18 years

Other

  • The patients have to meet best-corrected Snellen visual acuity of under 0.3 and spherical equivalent of under 6 diopter.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Català de Retina
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.