NCT06607705 Changes in Eye Pressure in Glaucoma Patients Treated with Istent Inject W, Monitored by a Contact Lens Sensor
| NCT ID | NCT06607705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacio Privada Mon Clinic Barcelona |
| Condition | Glaucoma Eye |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 53 participants in total. It began in 2024-10-21 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06607705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glaucoma Eye. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06607705 currently recruiting?
Yes, NCT06607705 is actively recruiting participants. Contact the research team at mgarcia@bcccbarcelona.cat for enrollment information.
Where is the NCT06607705 trial being conducted?
This trial is being conducted at Barcelona, Spain, Barcelona, Spain.
Who is sponsoring the NCT06607705 clinical trial?
NCT06607705 is sponsored by Fundacio Privada Mon Clinic Barcelona. The trial plans to enroll 53 participants.