Monitoring Eye Pressure in Glaucoma Patients After iStent Surgery
Uses a contact lens sensor to track eye pressure changes in glaucoma patients.
Plain-language title generated from the registry record
Registry title: Changes in Eye Pressure in Glaucoma Patients Treated with Istent Inject W, Monitored by a Contact Lens Sensor
Key facts
- Where
- Barcelona, SpainSee the 2 sites
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Institut Català de RetinaBarcelona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacio Privada Mon Clinic Barcelona
- Trial code
- NCT06607705
- Record updated
- 6 March 2025
- Original description
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.Read full original descriptionShow less
Fluctuations of the Intraocular Pressure in Surgically Treated Glaucoma Patients with IStent Inject W by a Contact Lens Sensor
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.
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: We will not include patients with previous ocular surgery, except cataract surgery performed at least 6 months prior to the inclusion date; 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; Age under 18 years; The patients have to meet best-corrected Snellen visual acuity of under 0.3 and spherical equivalent of under 6 diopter.