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
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- Subject who was withdrawn from the previous studies (MMS EEU-4 and MMS EEU-7)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