GlaucomaNCT07081347
This Follow-up Extension Study is Aimed to Monitor the Long-term IOP-lowering Performance/Efficacy and Safety of the MINT® Procedure in Open Angle Glaucoma Eyes.
A study testing MINT Minimally Invasive Nasal Trabeculostomy in people with Glaucoma and Ocular Hypertension, run by Sanoculis Ltd at 1 site in Armenia.
Trial summary
This follow-up extension study is planned to invite all patients who underwent the MINT® surgery and completed Month 24 Visit in the prior MMS EEU-7 study. It is assumed that approximately 20 patients/eyes, achieved qualified success of ≥20% IOP reduction from baseline without reoperation for glaucoma and with same or… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
- What is being tested?
- MINT Minimally Invasive Nasal Trabeculostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteArmenia
- Study dates
- 16 Jun 2025to 2 Aug 2025
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years to ≤ 85 years old
- Subject who underwent MINT, in continuation of the previous clinical investigation with the MINT® device (see: STUDY ID: MMS EEU-4), and surgery was performed not earlier than 30 months from enrollment
- Subject is able and willing to attend all scheduled follow-up exams
- Subject understands and signs the informed consent
Who cannot join
- Subject who was withdrawn from the previous studies (MMS EEU-4 and MMS EEU-7)
- Any ocular surgery since the MINT® surgery in the study eye
- Severe trauma in the study eye since the MINT® surgery in the study eye (except for uncomplicated cataract surgery or laser therapy)
- Current participation in another investigational drug or device clinical trial or participation is such trial within the last 30 days before enrollment into the study
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Nasal Trabeculostomy: Long-Term Follow-Up Extension Study
This follow-up extension study is planned to invite all patients who underwent the MINT® surgery and completed Month 24 Visit in the prior MMS EEU-7 study.
It is assumed that approximately 20 patients/eyes, achieved qualified success of ≥20% IOP reduction from baseline without reoperation for glaucoma and with same or less medications in the prior MMS EEU-7 study, will be available for assessment in this study. The data from these patients will be included in the IOP performance and medication use analysis.
Read more
In addition to these subjects, data from subjects defined as failure in the prior investigations with MINT® (see: STUDY ID: MMS EEU-4; STUDY ID: MMS EEU-7) will be included in the overall success analysis (i.e., Kaplan Mayer survival analysis).
Based on recommendations of the EGS expert discussion group (European Glaucoma Society (EGS), 2023), the IOP levels of 2-3 mmHg and 20%-30% medication free patients have been proposed as the minimal clinically important difference (MCID) for surgical interventions for glaucoma.
In this study, by 3 years post MINT® surgery, a sample size of 20 patients is expected to be adequate to demonstrate a reduction of at least -6 mmHg with 95% confidence interval (CI) lower limit of at least -4.6 mmHg which is higher than the MCID required; and at least 45% of free-medication patients with 95%CI lower limit of 21.8% which is in line with the minimum MCID recommendations.
- Conditions
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
- Being tested
- MINT Minimally Invasive Nasal Trabeculostomy
- Medical subject headings
- Glaucoma, Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINT Minimally Invasive Nasal TrabeculostomyDevice
The MINT® system is a powered surgical device for ab-interno nasal trabeculostomy. It creates ~100-micron trabeculostomy openings from the anterior chamber into Schlemm's canal by removing trabecular meshwork (TM) segments. The system includes a sterile stainless-steel Surgical Device with a micro trephine, driven by a motorized Activation Device that controls rotation and movement. The procedure facilitates aqueous outflow to lower IOP, with minimal collateral tissue damage.
| Study group | Role | What they receive |
|---|---|---|
| MINT® Surgical Intervention | Experimental | Participants will undergo a single MINT® (Minimally Invasive Nasal Trabeculostomy) procedure as a standalone or combined intervention for the treatment of glaucoma. All participants will be followed for 36 months to evaluate intraocular pressure (IOP) outcomes, reduction in IOP-lowering medications, and safety parameters. Receives: Device: MINT Minimally Invasive Nasal Trabeculostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success will be evaluated as following:
- Proportion of patients achieving ≥20% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony*, while staying on same or fewer topical IOP-lowering medications than at baseline.
- Proportion of patients achieving ≥25% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony*, while staying on same or fewer topical IOP-lowering medications than at baseline
- Proportion of patients achieving ≥20% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony*, while taking no topical IOP-lowering medications.
- Proportion of patients achieving ≥25% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony*, while taking no topical IOP-lowering medications.
Measured: • Success rates 36 months post-MINT® surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start16 Jun 2025
- Primary completion2 Aug 2025
- Study completion2 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanoculis Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081347
- Sponsor's protocol ID
- MMS EEU-10
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Nasal Trabeculostomy: Long-Term Follow-Up Extension Study
- ClinicalTrials.gov ID
- NCT07081347
- Acronym / sponsor ID
- MMS EEU-10
- Conditions
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sanoculis LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 2 Aug 2025 (actual)
- Study completion
- 2 Aug 2025 (actual)
- First posted
- 23 Jul 2025 (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.
This follow-up extension study is planned to invite all patients who underwent the MINT® surgery and completed Month 24 Visit in the prior MMS EEU-7 study.
It is assumed that approximately 20 patients/eyes, achieved qualified success of ≥20% IOP reduction from baseline without reoperation for glaucoma and with same or less medications in the prior MMS EEU-7 study, will be available for assessment in this study. The data from these patients will be included in the IOP performance and medication use analysis.
In addition to these subjects, data from subjects defined as failure in the prior investigations with MINT® (see: STUDY ID: MMS EEU-4; STUDY ID: MMS EEU-7) will be included in the overall success analysis (i.e., Kaplan Mayer survival analysis).
Based on recommendations of the EGS expert discussion group (European Glaucoma Society (EGS), 2023), the IOP levels of 2-3 mmHg and 20%-30% medication free patients have been proposed as the minimal clinically important difference (MCID) for surgical interventions for glaucoma.
In this study, by 3 years post MINT® surgery, a sample size of 20 patients is expected to be adequate to demonstrate a reduction of at least -6 mmHg with 95% confidence interval (CI) lower limit of at least -4.6 mmHg which is higher than the MCID required; and at least 45% of free-medication patients with 95%CI lower limit of 21.8% which is in line with the minimum MCID recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MINT® Surgical Intervention | Experimental | Device: MINT Minimally Invasive Nasal TrabeculostomyParticipants will undergo a single MINT® (Minimally Invasive Nasal Trabeculostomy) procedure as a standalone or combined intervention for the treatment of glaucoma. All participants will be followed for 36 months to evaluate intraocular pressure (IOP) outcomes, reduction in IOP-lowering medications, and safety parameters. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years to ≤ 85 years old
- Subject who underwent MINT, in continuation of the previous clinical investigation with the MINT® device (see: STUDY ID: MMS EEU-4), and surgery was performed not earlier than 30 months from enrollment
- Subject is able and willing to attend all scheduled follow-up exams
- Subject understands and signs the informed consent
Key exclusion criteria (5 listed)
- Subject who was withdrawn from the previous studies (MMS EEU-4 and MMS EEU-7)
- Any ocular surgery since the MINT® surgery in the study eye
- Severe trauma in the study eye since the MINT® surgery in the study eye (except for uncomplicated cataract surgery or laser therapy)
- Current participation in another investigational drug or device clinical trial or participation is such trial within the last 30 days before enrollment into the study
- Pregnant or lactating women
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 |
|---|---|---|
| MINT Minimally Invasive Nasal TrabeculostomyThe MINT® system is a powered surgical device for ab-interno nasal trabeculostomy. It creates ~100-micron trabeculostomy openings from the anterior chamber into Schlemm's canal by removing trabecular meshwork (TM) segments. The system includes a sterile stainless-steel Surgical Device with a micro trephine, driven by a motorized Activation Device that controls rotation and movement. The procedure facilitates aqueous outflow to lower IOP, with minimal collateral tissue damage. | Device | MINT® Surgical Intervention |
Primary outcome
Success will be evaluated as following:
Time frame: • Success rates 36 months post-MINT® surgery
* Proportion of patients achieving ≥20% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony*, while staying on same or fewer topical IOP-lowering medications than at baseline. * Proportion of patients achieving ≥25% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony*, while staying on same or fewer topical IOP-lowering medications than at baseline * Proportion of patients achieving ≥20% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony*, while taking no topical IOP-lowering medications. * Proportion of patients achieving ≥25% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony*, while taking no topical IOP-lowering medications.
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 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINT Minimally Invasive Nasal Trabeculostomy in people with Glaucoma and Ocular Hypertension, run by Sanoculis Ltd at 1 site in Armenia.
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 4 inclusion and 5 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 15 Oct 2026. 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 Armenia. 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?
Success will be evaluated as following: (time frame: • Success rates 36 months post-MINT® surgery). 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 15 Oct 2026.