Status:
RECRUITING
Changes in Eye Pressure in Glaucoma Patients Treated with Istent Inject W, Monitored by a Contact Lens Sensor
Lead Sponsor:
Fundacio Privada Mon Clinic Barcelona
Collaborating Sponsors:
Glaukos Corporation
Conditions:
Glaucoma Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
This is a prospective controlled pre-post intervention study conducted at a Hospital Clínic of Barcelona, a university hospital in Barcelona, Spain. This study will be adhered to the tenets of the Dec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06607705
Start Date
October 21 2024
End Date
October 1 2025
Last Update
March 6 2025
Active Locations (2)
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1
Institut Català de Retina
Barcelona, Spain, Spain, 08022
2
Hospital Clínic de Barcelona
Barcelona, Spain, Spain, 08036