Monitoring eye pressure changes in glaucoma patients using a contact lens sensor after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate fluctuations in intraocular pressure (IOP) in glaucoma patients treated with the iStent inject W, using a contact lens sensor (CLS) for monitoring. It is a prospective controlled pre-post intervention conducted at the Hospital Clínic of Barcelona, where participants will wear the CLS for 24 hours prior to surgery while continuing their anti-glaucoma medications. The study will compare IOP changes in patients undergoing surgery with those receiving only medical treatment. The expected duration of the study is around 12 months, with recruitment lasting 6 to 8 months.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institut Català de Retina
  Barcelona, Spain, Spain Recruiting
• Hospital Clínic de Barcelona
  Barcelona, Spain, Spain Recruiting

Study contacts

• Study coordinator: María García
• Email: mgarcia@bcccbarcelona.cat
• Phone: +34 645089918

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.