Glaucoma, Open-AngleNCT03624699
Investigation of the iStent Inject® Devices in Open-Angle Glaucoma
A study testing Glaukos iStent inject® in people with Glaucoma, Open-Angle, run by Dr. Kaweh Mansouri at 1 site in Switzerland.
Trial summary
The aim of this study is to evaluate the safety and intraocular pressure (IOP) lowering effect of two iStent inject devices in combination with cataract surgery in patients with mild-to-moderate open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Glaukos iStent inject®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Apr 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma
- Mild to moderate glaucoma (defined as C/D ratio ≤ 0.8)
- Phakic eye requiring cataract surgery
- Preoperative IOP up to 30 mmHg (medicated or not)
- Patients with side-effects to, or complications from, medications
- Patients who would benefit from a reduction of IOP and/or reduction of medication
Show all 10Show fewer
- Normal angle anatomy as determined by gonioscopy;
- Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair proper placement of iStent inject device
- Able and willing to attend scheduled follow-up exams for 12 months postoperatively
- Able and willing to provide written informed consent on the approved Informed Consent Form
Who cannot join
- Inclusion of the fellow eye in this study (only one eye per subject)
- Aphakic patients or pseudophakic patients
- Prior stent implantations in the study eye
- Eyes with primary angle closure glaucoma, or any secondary angle closure glaucoma
- Traumatic or uveitic glaucoma; or any glaucoma associated with vascular disorders
- Patients with any type of condition that may cause elevated episcleral venous pressure
Show all 12Show fewer
- Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma
- Prior glaucoma treatment (laser or surgery)
- Any active corneal inflammation, edema, or opacity severe-enough to impair gonioscopy / fundus examination
- Any pathology for which, in the investigator's judgment, the following would be either at risk or contraindicated:
- stent implantation,
- compliance to elements of the study protocol.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Glaucoma Research Centre, Montchoisi Clinic
Lausanne, Canton of Vaud, 1006
About this study
Official title: A Prospective, Unmasked, Single-Site Investigation of the iStent Inject® Devices Implanted in Combination With Cataract Surgery in Patients With Open-Angle Glaucoma
The aim of this study is to evaluate the safety and intraocular pressure (IOP) lowering effect of two iStent inject devices in combination with cataract surgery in patients with mild-to-moderate open-angle glaucoma.
Read the detailed description
Patients suffering from open-angle glaucoma who are planning to undergo cataract surgery and are matching the inclusion criteria will be offered to join the study until the desired sample size (50) is reached. Combined cataract-iStent surgery will be performed as per the devices' manufacturers' instructions. Two iStent inject devices will be micro-invasively implanted in the trabecular meshwork of the eye during planned cataract surgery. Six post-operative follow-ups will be carried out over a duration of 12 months, during which various measurements will be made. Performance Outcomes will analyse the proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 6 and 12 months. Quality of life outcome will look at the improvement in perceived quality of life as expressed in the NEI VFQ-25 questionnaires from baseline to 3 and 12 months. The rate of adverse events will be recorded.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Glaukos iStent inject®
- Keywords
- glaucoma, Minimally Invasive Glaucoma Surgery
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaukos iStent inject®Device
iStent inject® Devices Implanted in Combination with Cataract Surgery in Patients with Open-Angle Glaucoma
| Study group | Role | What they receive |
|---|---|---|
| Glaukos iStent inject® | Experimental | Patients suffering from cataract and open-angle glaucoma. Glaukos iStent inject® is implanted during routine cataract surgery. The effect on IOP/glaucoma medications is monitored. Receives: Device: Glaukos iStent inject® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Outcome: IOP reduction
Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months.
Measured: 12 months
Secondary outcomes (2)
Quality of life: NEI VFQ-25 score
Improvement in perceived quality of life as expressed in the NEI VFQ-25 (National Eye Institute Vision Function) questionnaires from baseline to 12 months.
Measured: 12 months
Safety Outcome: Adverse events
Rate of adverse events through the follow-up period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start25 Apr 2018
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Historic control (before vs. after intervention).
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Kaweh Mansouri
- Sponsor type
- University, hospital or other
- Collaborators
- Glaukos Corporation
- Responsible party
- Sponsor-investigator, Dr. Kaweh Mansouri, Swiss Vision Network
- Investigators
- Kaweh Mansouri, MD MPH, Study director, Glaucoma Research Centre, Montchoisi Clinic, LausanneAndré Mermoud, MD, Study director, Glaucoma Research Centre, Montchoisi Clinic, Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624699
- Sponsor's protocol ID
- GLK-iStent-inject
- Status last verified
- May 2022
- First submitted
- 7 Aug 2018
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gillmann K, Mansouri K, Ambresin A, Bravetti GE, Mermoud A. A Prospective Analysis of iStent Inject Microstent Implantation: Surgical Outcomes, Endothelial Cell Density, and Device Position at 12 Months. J Glaucoma. 2020 Aug;29(8):639-647. doi: 10.1097/IJG.0000000000001546.
PubMed 32433094
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Unmasked, Single-Site Investigation of the iStent Inject® Devices Implanted in Combination With Cataract Surgery in Patients With Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT03624699
- Acronym / sponsor ID
- GLK-iStent-inject
- Conditions
- Glaucoma, Open-Angle
- Keywords
- glaucoma, Minimally Invasive Glaucoma Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dr. Kaweh MansouriUniversity, hospital or other
- Collaborators
- Glaukos Corporation
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 10 Aug 2018 (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 aim of this study is to evaluate the safety and intraocular pressure (IOP) lowering effect of two iStent inject devices in combination with cataract surgery in patients with mild-to-moderate open-angle glaucoma.
Detailed description
Patients suffering from open-angle glaucoma who are planning to undergo cataract surgery and are matching the inclusion criteria will be offered to join the study until the desired sample size (50) is reached. Combined cataract-iStent surgery will be performed as per the devices' manufacturers' instructions. Two iStent inject devices will be micro-invasively implanted in the trabecular meshwork of the eye during planned cataract surgery. Six post-operative follow-ups will be carried out over a duration of 12 months, during which various measurements will be made. Performance Outcomes will analyse the proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 6 and 12 months. Quality of life outcome will look at the improvement in perceived quality of life as expressed in the NEI VFQ-25 questionnaires from baseline to 3 and 12 months. The rate of adverse events will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Historic control (before vs. after intervention).
| Arm | Type | Receives |
|---|---|---|
| Glaukos iStent inject® | Experimental | Device: Glaukos iStent inject®Patients suffering from cataract and open-angle glaucoma. Glaukos iStent inject® is implanted during routine cataract surgery. The effect on IOP/glaucoma medications is monitored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma
- Mild to moderate glaucoma (defined as C/D ratio ≤ 0.8)
- Phakic eye requiring cataract surgery
- Preoperative IOP up to 30 mmHg (medicated or not)
- Patients with side-effects to, or complications from, medications
Key exclusion criteria (12 listed)
- Inclusion of the fellow eye in this study (only one eye per subject)
- Aphakic patients or pseudophakic patients
- Prior stent implantations in the study eye
- Eyes with primary angle closure glaucoma, or any secondary angle closure glaucoma
- Traumatic or uveitic glaucoma; or any glaucoma associated with vascular disorders
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 |
|---|---|---|
| Glaukos iStent inject®iStent inject® Devices Implanted in Combination with Cataract Surgery in Patients with Open-Angle Glaucoma | Device | Glaukos iStent inject® |
Primary outcome
Performance Outcome: IOP reduction
Time frame: 12 months
Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months.
2 secondary outcomes
Quality of life: NEI VFQ-25 score
Time frame: 12 months
Safety Outcome: Adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 32433094Gillmann K, Mansouri K, Ambresin A, Bravetti GE, Mermoud A. A Prospective Analysis of iStent Inject Microstent Implantation: Surgical Outcomes, Endothelial Cell Density, and Device Position at 12 Months. J Glaucoma. 2020 Aug;29(8):639-647. doi: 10.1097/IJG.0000000000001546.
- Individual participant dataSharing planned: No
Related trials for Glaucoma, Open-Angle
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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. This study is not recruiting at the moment.
Kaweh Mansouri, MD MPH study director
Glaucoma Research Centre, Montchoisi Clinic, Lausanne
André Mermoud, MD study director
Glaucoma Research Centre, Montchoisi Clinic, Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glaukos iStent inject® in people with Glaucoma, Open-Angle, run by Dr. Kaweh Mansouri at 1 site in Switzerland.
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 10 inclusion and 12 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: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Outcome: IOP reduction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624699, which also lists 1 linked publication.
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 5 May 2022.