Actively Recruiting
Fluctuations of Intraocular Pressure in Glaucoma Patients Treated with iStent Inject W Using a Contact Lens Sensor
Led by Fundacio Privada Mon Clinic Barcelona · Updated on 2025-03-06
53
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating fluctuations in eye pressure in glaucoma patients using the Sensimed Triggerfish contact lens sensor (CLS). The study compares patients undergoing glaucoma surgery with iStent inject W to those treated only with eye drops and requiring cataract surgery. This prospective controlled study aims to observe changes in intraocular pressure (IOP) under normal daily conditions before and after surgery. Participants will wear the CLS device for 24 hours during three monitoring visits: one month before surgery, and one month and three months after surgery. The device is placed by an ophthalmologist after measuring corneal curvature and records IOP-related fluctuations while participants continue their normal activities and usual eye drop regimen. A control group will undergo similar monitoring before and after cataract surgery without changes to their medical treatment. During the study, participants will attend clinic visits for device placement and removal, eye exams including Goldmann applanation tonometry, and fill out logs recording sleep and medication times. Researchers will analyze fluctuations in IOP over 24 hours, rates of IOP increase and decrease, and sleep-wake slope changes. Follow-up extends to three months post-surgery to assess the durability of surgical effects on IOP variability.
CONDITIONS
Brief Title
Changes in Eye Pressure in Glaucoma Patients Treated with Istent Inject W, Monitored by a Contact Lens Sensor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old with primary open-angle glaucoma (POAG) or normal tension glaucoma (NTG) diagnosed with untreated intraocular pressure (IOP) over 21 mm Hg
- Patients with open normal appearing angles, typical glaucomatous optic nerve damage, and typical visual field defects
- Patients with unilateral or bilateral POAG without previous eye surgery, treated with topical anti-glaucoma medications, who need glaucoma surgery with iStent inject W
- Patients requiring cataract surgery and treated only with topical hypotensive glaucoma medication (control group)
You will not qualify if you...
- Age under 18 years
- Visual defects due to non-glaucoma conditions, primary angle closure glaucoma, neovascular glaucoma, history of eye trauma, retinal disease, ocular inflammation, laser therapy, or secondary glaucoma
- Best-corrected visual acuity worse than 0.3 and spherical equivalent greater than 6 diopters
- Previous eye surgery except cataract surgery performed at least 6 months before study inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants wear a contact lens sensor (CLS) for 24 hours to monitor intraocular pressure fluctuations before surgery while continuing their usual glaucoma medication regimen.
2 visits (in-person) for CLS placement and removal
Duration - 1 day
Participants undergo glaucoma surgery with iStent inject W, with or without combined cataract surgery.
1 visit (in-person) for surgery
Duration - 2 days spread over 3 months
Participants wear the contact lens sensor for 24 hours at 1 month and 3 months after surgery to monitor intraocular pressure fluctuations and assess the sustained effects of the surgery.
4 visits (in-person) for CLS placement and removal at 1 and 3 months post-surgery
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
Research Team
M
María García
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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