Changes in Eye Pressure in Glaucoma Patients Treated with Istent Inject W, Monitored by a Contact Lens Sensor

NCT06607705 | Recruiting

• 1 other identifier: GLAUKOS
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Glaucoma Eye

Keywords

intraocular pressure (IOP); glaucoma; cataract; ophthalmology; Contact Lens Sensor (CLS); Glaucoma surgery; iStent inject W; Sensimed Triggerfish

Outcome Measures

Primary Outcomes (8)

• IOP-related fluctuation over a 24- hour period

  The amplitude of the cosine curve is a parameter based on the cosine model fitted to the CLS data. The amplitude is the difference between the maximum and minimum values of the cosine-fit curve divided by 2. This is an overall estimate of the magnitude of signal oscillation during the tested period. The cosinor model represents the actual amplitude of IOP-related fluctuation over a 24- hour period and is most representative of IOP-related changes. IOP-related fluctuations will be calculated based on the GAT IOP measured at baseline and at each visit during the study. Control group will not be monitored in the 1-month visit.

  24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit

• CLS increase and decrease rates

  CLS (Contact Lens Sensor) increase and decrease rates (change in CLS units/ change in time): maximum Control group will not be monitored in the 1-month visit.

  24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit

• CLS increase and decrease rates

  CLS (Contact Lens Sensor) increase and decrease rates (change in CLS units/ change in time): minimum. Control group will not be monitored in the 1-month visit.

  24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit

• CLS increase and decrease rates

  CLS (Contact Lens Sensor) increase and decrease rates (change in CLS units/ change in time): median. Control group will not be monitored in the 1-month visit.

  24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit

• CLS increase and decrease rates

  CLS (Contact Lens Sensor) increase and decrease rates (change in CLS units/ change in time): mean. Control group will not be monitored in the 1-month visit.

  24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit

• Sleep-to-wake slope

  Calculation of sleep-to-wake slope. Control group will not be monitored in the 1-month visit.

  24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit

• Wake-to-sleep slope

  Calculation of wake-to-sleep slope. Control group will not be monitored in the 1-month visit.

  24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit

• Number of peaks of IOP-related fluctuations

  Number of peaks: over 24 hours, inferior to 30 minutes, superior to 90mVeq. Control group will not be monitored in the 1-month visit.

  24 hours during 1-month pre-intervention visit, 24 hours during 1-month post-intervention visit and 24 hours during 3-month post-intervention visit

Study Arms (2)

Surgery required glaucoma

EXPERIMENTAL

Treatment group

Device: Monitoring with contact lens sensor

Medically controlled glaucoma

EXPERIMENTAL

Control group

Device: Monitoring with contact lens sensor

Interventions

Monitoring with contact lens sensor DEVICE

Monitoring with contact lens sensor at 1-month pre-intervention visit

Medically controlled glaucoma; Surgery required glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio Privada Mon Clinic Barcelona: lead
• Glaukos Corporation: collaborator

Study Sites (2)

Institut Català de Retina

Barcelona, Spain, 08022, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Spain, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Glaucoma; Cataract

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Central Study Contacts

María García

CONTACT

+34 645089918; mgarcia@bcccbarcelona.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, non-randomized, controlled, single country pre-post intervention study.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 23, 2024
• Study Start: October 21, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)