Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06607705

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

Led by Fundacio Privada Mon Clinic Barcelona · Updated on 2025-03-06

53

Participants Needed

2

Research Sites

49 weeks

Total Duration

On this page

Sponsors

F

Fundacio Privada Mon Clinic Barcelona

Lead Sponsor

G

Glaukos Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old diagnosed with primary open-angle glaucoma (POAG) or normal-tension glaucoma (NTG)
  • Untreated intraocular pressure (IOP) over 21 mm Hg as indicated in patient records
  • Patients with open normal appearing angles, typical glaucomatous optic atrophy, and glaucomatous visual field damage
  • Patients with unilateral or bilateral open-angle glaucoma without previous eye surgery (except cataract surgery over 6 months ago)
  • Patients treated with topical anti-glaucoma medications who require glaucoma surgery with iStent inject W
  • Patients undergoing isolated iStent surgery or combined cataract and iStent surgery
  • For control group: patients treated with topical hypotensive glaucoma medication requiring cataract surgery
Not Eligible

You will not qualify if you...

  • Age under 18 years old
  • Visual defects due to non-glaucoma conditions
  • Primary angle closure glaucoma or neovascular glaucoma
  • History of ocular trauma, retinal disease, ocular inflammation, or secondary glaucoma
  • Patients with best-corrected visual acuity under 0.3 or spherical equivalent under 6 diopters
  • Previous ocular surgery except cataract surgery done at least 6 months before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Institut Català de Retina

Barcelona, Spain, Spain, 08022

Actively Recruiting

2

Hospital Clínic de Barcelona

Barcelona, Spain, Spain, 08036

Actively Recruiting

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Research Team

M

María García

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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