Glaucoma EyeNCT06607705
Changes in Eye Pressure in Glaucoma Patients Treated with Istent Inject W, Monitored by a Contact Lens Sensor
A study testing Monitoring with contact lens sensor in people with Glaucoma Eye, run by Fundacio Privada Mon Clinic Barcelona at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma Eye
- What is being tested?
- Monitoring with contact lens sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesSpain
- Study dates
- 21 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Institut Català de Retina
Barcelona, Spain, 08022
José Manuel Navero, +34 932 54 79 20, josemanuel.navero@icrcat.com
José Manuel Navero
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Maria Jesús Muniesa, +34 932 84 20 40, mariajesus.muniesa@gmail.com
Maria Jesús Muniesa
About this study
Official title: 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.
Read the 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 Declaration of Helsinki. Informed patient consent and approval by the Institutional Review Board will be obtained prior to study commencement. Study duration is expected to be around 12 months, recruitment period would last between 6 to 8 months and study is expected to be finalized by Jun 2025.
The study will recruit consenting adults (over 18 years old) with unilateral or bilateral primary 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.
One month prior to glaucoma surgery with iStent inject W, subjects will wear the CLS for 24 hours without changing the regimen of anti-glaucoma eye drops. The CLS will be placed on the subject's eye by an ophthalmologist in the clinic after a slit lamp examination and keratometry to determine the corneal curvature for selection of the appropriate CLS base curve. The subjects will then return home and carry on their routine activities (both indoor and outdoor), apart from showering or swimming (as the device cannot be in contact with water). Subjects will continue the same regimen of anti-glaucoma eye drops and slept in their habitual position at night. Each subject will carry a logbook to record sleeping and medication instillation times during the 24-hour period. After 24 hours, the subject will return to the clinic to have the contact lens removed followed by a slit lamp examination. The data recorded by the CLS will be uploaded into a computer database. Goldmann applanation tonometry (GAT) will be perform before and after each CLS wear by a single observer. At 1-month (n=9/44) and 3-month (n=44) post-glaucoma surgery with iStent implant, patients will wear the CLS in the same eye that received the first CLS recording. As before, the CLS will be removed 24 hours later. To extend the follow-up to 3 months after surgery will allow us to corroborate that the effects of the surgery on fluctuations of IOP for 24 hours are maintained over time. In the control group (n=10) , a first monitoring with CLS will be carried out one month before cataract surgery, and a second monitoring will be carried out 3 months after this cataract surgery, without us having introduced any changes in their hypotensive medical treatment.
- Conditions
- Glaucoma Eye
- Being tested
- Monitoring with contact lens sensor
- Keywords
- intraocular pressure (IOP), glaucoma, cataract, ophthalmology, Contact Lens Sensor (CLS), Glaucoma surgery, iStent inject W, Sensimed Triggerfish
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring with contact lens sensorDevice
Monitoring with contact lens sensor at 1-month pre-intervention visit
Monitoring with contact lens sensorDevice
Monitoring with contact lens sensor at 1-month post-intervention visit
Monitoring with contact lens sensorDevice
Monitoring with contact lens sensor at 3-months post-intervention visit
| Study group | Role | What they receive |
|---|---|---|
| Surgery required glaucoma | Experimental | Treatment group Receives: Device: Monitoring with contact lens sensor |
| Medically controlled glaucoma | Experimental | Control group Receives: Device: Monitoring with contact lens sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start21 Oct 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, non-randomized, controlled, single country pre-post intervention study.
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Privada Mon Clinic Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Glaukos Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607705
- Sponsor's protocol ID
- GLAUKOS
- Status last verified
- Mar 2025
- First submitted
- 16 Sep 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluctuations of the Intraocular Pressure in Surgically Treated Glaucoma Patients with IStent Inject W by a Contact Lens Sensor
- ClinicalTrials.gov ID
- NCT06607705
- Acronym / sponsor ID
- GLAUKOS
- Conditions
- Glaucoma Eye
- Keywords
- intraocular pressure (IOP), glaucoma, cataract, ophthalmology, Contact Lens Sensor (CLS), Glaucoma surgery, iStent inject W, Sensimed Triggerfish
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Fundacio Privada Mon Clinic BarcelonaUniversity, hospital or other
- Collaborators
- Glaukos Corporation
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Declaration of Helsinki. Informed patient consent and approval by the Institutional Review Board will be obtained prior to study commencement. Study duration is expected to be around 12 months, recruitment period would last between 6 to 8 months and study is expected to be finalized by Jun 2025.
The study will recruit consenting adults (over 18 years old) with unilateral or bilateral primary 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.
One month prior to glaucoma surgery with iStent inject W, subjects will wear the CLS for 24 hours without changing the regimen of anti-glaucoma eye drops. The CLS will be placed on the subject's eye by an ophthalmologist in the clinic after a slit lamp examination and keratometry to determine the corneal curvature for selection of the appropriate CLS base curve. The subjects will then return home and carry on their routine activities (both indoor and outdoor), apart from showering or swimming (as the device cannot be in contact with water). Subjects will continue the same regimen of anti-glaucoma eye drops and slept in their habitual position at night. Each subject will carry a logbook to record sleeping and medication instillation times during the 24-hour period. After 24 hours, the subject will return to the clinic to have the contact lens removed followed by a slit lamp examination. The data recorded by the CLS will be uploaded into a computer database. Goldmann applanation tonometry (GAT) will be perform before and after each CLS wear by a single observer. At 1-month (n=9/44) and 3-month (n=44) post-glaucoma surgery with iStent implant, patients will wear the CLS in the same eye that received the first CLS recording. As before, the CLS will be removed 24 hours later. To extend the follow-up to 3 months after surgery will allow us to corroborate that the effects of the surgery on fluctuations of IOP for 24 hours are maintained over time. In the control group (n=10) , a first monitoring with CLS will be carried out one month before cataract surgery, and a second monitoring will be carried out 3 months after this cataract surgery, without us having introduced any changes in their hypotensive medical treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, non-randomized, controlled, single country pre-post intervention study.
| Arm | Type | Receives |
|---|---|---|
| Surgery required glaucoma | Experimental | Device: Monitoring with contact lens sensorTreatment group |
| Medically controlled glaucoma | Experimental | Device: Monitoring with contact lens sensorControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring with contact lens sensorMonitoring with contact lens sensor at 1-month pre-intervention visit | Device | Medically controlled glaucoma, Surgery required glaucoma |
| Monitoring with contact lens sensorMonitoring with contact lens sensor at 1-month post-intervention visit | Device | Surgery required glaucoma |
| Monitoring with contact lens sensorMonitoring with contact lens sensor at 3-months post-intervention visit | Device | Medically controlled glaucoma, Surgery required glaucoma |
Primary outcome
IOP-related fluctuation over a 24- hour period
Time frame: 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
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.
CLS increase and decrease rates
Time frame: 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 (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.
CLS increase and decrease rates
Time frame: 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 (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.
CLS increase and decrease rates
Time frame: 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 (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.
CLS increase and decrease rates
Time frame: 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 (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.
Sleep-to-wake slope
Time frame: 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
Calculation of sleep-to-wake slope. Control group will not be monitored in the 1-month visit.
Wake-to-sleep slope
Time frame: 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
Calculation of wake-to-sleep slope. Control group will not be monitored in the 1-month visit.
Number of peaks of IOP-related fluctuations
Time frame: 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: over 24 hours, inferior to 30 minutes, superior to 90mVeq. Control group will not be monitored in the 1-month visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring with contact lens sensor in people with Glaucoma Eye, run by Fundacio Privada Mon Clinic Barcelona at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María García (+34 645089918, mgarcia@bcccbarcelona.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP-related fluctuation over a 24- hour period (time frame: 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.