Monitoring eye pressure changes in glaucoma patients using a contact lens sensor after surgery
Fluctuations of the Intraocular Pressure in Surgically Treated Glaucoma Patients with IStent Inject W by a Contact Lens Sensor
This study is testing if a special contact lens can help track eye pressure changes in glaucoma patients after they have surgery compared to those who only use medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacio Privada Mon Clinic Barcelona Academic / other |
| Locations | 2 sites (Barcelona, Spain and 1 other locations) |
| Trial ID | NCT06607705 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate fluctuations in intraocular pressure (IOP) in glaucoma patients treated with the iStent inject W, using a contact lens sensor (CLS) for monitoring. It is a prospective controlled pre-post intervention conducted at the Hospital Clínic of Barcelona, where participants will wear the CLS for 24 hours prior to surgery while continuing their anti-glaucoma medications. The study will compare IOP changes in patients undergoing surgery with those receiving only medical treatment. The expected duration of the study is around 12 months, with recruitment lasting 6 to 8 months.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with primary open-angle glaucoma requiring surgery and untreated IOP over 21 mm Hg.
Not a fit: Patients with previous eye surgeries or those not diagnosed with primary open-angle glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of eye pressure in glaucoma patients, potentially enhancing treatment outcomes.
How similar studies have performed: Other studies have shown promise in using contact lens sensors for monitoring IOP, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona, Spain and 1 other locations
- Institut Català de Retina — Barcelona, Spain, Spain (Recruiting)
- Hospital Clínic de Barcelona — Barcelona, Spain, Spain (Recruiting)
Study contacts
- Study coordinator: María García
- Email: mgarcia@bcccbarcelona.cat
- Phone: +34 645089918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.