This Study is Obtained Under Inclusion/ Exclusion CriteriaNCT05638906
Minimally Invasive Nasal Trabeculostomy - Performance and Safety Evaluation Study
A study testing MINT in people with This Study is Obtained Under Inclusion/ Exclusion Criteria, run by Sanoculis Ltd at 1 site in Armenia.
Trial summary
Minimally Invasive Nasal Trabeculostomy System is intended for the reduction of elevated Intraocular Pressure (IOP). The system is a powered surgical device, designed to create trabeculostomy openings of ~100 microns diameter each, via an ab-interno approach, directly from the anterior chamber (AC) into Schlemm's… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- This Study is Obtained Under Inclusion/ Exclusion Criteria
- What is being tested?
- MINT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteArmenia
- Study dates
- 11 Apr 2022to 4 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female ≥ 18 years to ≤ 85 years old 2. Unsatisfactory IOP level, i.e., IOP ≥21 mmHg, at the screening visit in the study eye 3. Manifest open angle glaucoma (OAG) with typical disc or visual field changes and open iridocorneal angle in the study eye (in accordance with European Glaucoma Society (EGS) criteria 1) 4. Optic nerve appearance characteristic of glaucoma in the study eye 5. Shaffer grade ≥ III in all four angle quadrants in the study eye 6. Subject is treated with 0 to 5 hypotensive medications in the study eye 7. Subject is able and willing to attend all scheduled follow-up exams 8. Subject understands and signs the informed consent
Who cannot join
- 1. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye 2. Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the Minimally Invasive Nasal Trabeculostomy procedure or the study eye is pseudophakic with posterior chamber intraocular lens (PCIOL) 3. Congenital or developmental glaucoma in either eye 4. Fixation threatening visual-field defects or IOP ≥40 mmHg in the study eye
- Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye
- Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye
- Subject has history of penetrating keratoplasty (PKP)
- Any previous surgery in the study eye (at the access site of the Minimally Invasive Nasal Trabeculostomy System application), where the conjunctiva is not intact and elastic (except for clear corneal cataract surgery)
- Any ocular disease or history in study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements
Show all 19Show fewer
- Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eye.
- Best-corrected visual acuity worse than 20/40 (Snellen equivalent) in the fellow eye
- History of idiopathic or autoimmune uveitis in either eye
- Severe trauma in study eye
- Active iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil, need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery in study eye within 12 month period
- Vitreous present in anterior chamber, prior vitrectomy or vitreous hemorrhage in study eye
- Aphakia
- Prior vitreoretinal surgery in study eye
- Clinically significant ocular inflammation or infection within 90 days prior to screening
- Unable to discontinue use of blood thinners in accordance with surgeon's standard preoperative instructions
- Uncontrolled systemic disease that in the opinion of the investigator would put the subject's health at risk and/or prevent the subject from completing all study visits
- Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Minimally Invasive Nasal Trabeculostomy System is intended for the reduction of elevated Intraocular Pressure (IOP).
The system is a powered surgical device, designed to create trabeculostomy openings of ~100 microns diameter each, via an ab-interno approach, directly from the anterior chamber (AC) into Schlemm's canal (SC) by removing segments of the trabecular meshwork (TM) (i.e., an ab-interno nasal trabeculostomy). The ab-interno approach aims to decrease IOP by increasing aqueous outflow through a direct communication from the AC to the outer wall of SC and the collector channels.
Read more
The opening in the nasal TM to the SC is created by a sterile surgical instrument (the Surgical Device) made of stainless steel and plastic, which is coupled to a rotating system (the Activation Device). The Surgical Device of the Minimally Invasive Nasal Trabeculostomy System consists of a stainless steel micro trephine, covered by a small needle-shaped sleeve with a rotating mechanism behind it. While being rotated, the Surgical Device enters and moves along the TM, removing TM tissue with minimal collateral damage.
Mechanical rotation of the Surgical Device is achieved by the rotating system (i.e., Activation Device), which is comprised of: (1) Controller which dictates the activation pulse duration, the rotations per minute (RPM) and the forwards and backwards movement of the micro trephine; (2) Motor; and (3) Footswitch.
- Being tested
- MINT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINTDevice
Mechanical rotation of the Surgical Device is achieved by the rotating system (i.e., Activation Device), which is comprised of: (1) Controller which dictates the activation pulse duration, the rotations per minute (RPM) and the forwards and backwards movement of the micro trephine; (2) Motor; and (3) Footswitch.
| Study group | Role | What they receive |
|---|---|---|
| single-arm study with intra-subject comparisons | Experimental | Study eyes of subjects with uncontrolled (IOP > 20 mmHg) open-angle glaucoma (OAG), where IOP is not controlled when using maximum tolerated glaucoma medications. Receives: Device: MINT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieved a 20% or greater reduction in IOP from Baseline on the same or fewer number of medications [time frame: 24 weeks
- Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or fewer number of medications. Subjects who will undergo a glaucoma-related secondary surgical intervention prior to the 24 weeks visit will be considered failures in the analysis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start11 Apr 2022
- Primary completion28 Nov 2023
- Study completion4 Dec 2023
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 This Study is Obtained Under Inclusion/ Exclusion CriteriaStudies 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
- 71 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
- NCT05638906
- Sponsor's protocol ID
- MMS EEU-4
- Status last verified
- Mar 2024
- First submitted
- 27 Nov 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Voskanyan L, Miroyan H, Papoyan V, Babayan H, Grover DS. Performance and Safety of Minimally Invasive Nasal Trabeculostomy (MINT) in Open-Angle Glaucoma: A 12-month Open-Label Study on Patients with No Other Glaucoma Surgeries. Clin Ophthalmol. 2025 Dec 19;19:4841-4853. doi: 10.2147/OPTH.S538801. eCollection 2025.
PubMed 41446893
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Nasal Trabeculostomy - Performance and Safety Evaluation Study
- ClinicalTrials.gov ID
- NCT05638906
- Acronym / sponsor ID
- MMS EEU-4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Sanoculis LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 6 Dec 2022 (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.
Minimally Invasive Nasal Trabeculostomy System is intended for the reduction of elevated Intraocular Pressure (IOP).
The system is a powered surgical device, designed to create trabeculostomy openings of ~100 microns diameter each, via an ab-interno approach, directly from the anterior chamber (AC) into Schlemm's canal (SC) by removing segments of the trabecular meshwork (TM) (i.e., an ab-interno nasal trabeculostomy). The ab-interno approach aims to decrease IOP by increasing aqueous outflow through a direct communication from the AC to the outer wall of SC and the collector channels.
The opening in the nasal TM to the SC is created by a sterile surgical instrument (the Surgical Device) made of stainless steel and plastic, which is coupled to a rotating system (the Activation Device). The Surgical Device of the Minimally Invasive Nasal Trabeculostomy System consists of a stainless steel micro trephine, covered by a small needle-shaped sleeve with a rotating mechanism behind it. While being rotated, the Surgical Device enters and moves along the TM, removing TM tissue with minimal collateral damage.
Mechanical rotation of the Surgical Device is achieved by the rotating system (i.e., Activation Device), which is comprised of: (1) Controller which dictates the activation pulse duration, the rotations per minute (RPM) and the forwards and backwards movement of the micro trephine; (2) Motor; and (3) Footswitch.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm study with intra-subject comparisons | Experimental | Device: MINTStudy eyes of subjects with uncontrolled (IOP > 20 mmHg) open-angle glaucoma (OAG), where IOP is not controlled when using maximum tolerated glaucoma medications. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Male or female ≥ 18 years to ≤ 85 years old 2. Unsatisfactory IOP level, i.e., IOP ≥21 mmHg, at the screening visit in the study eye 3. Manifest open angle glaucoma (OAG) with typical disc or visual field changes and open iridocorneal angle in the study eye (in accordance with European Glaucoma Society (EGS) criteria 1) 4. Optic nerve appearance characteristic of glaucoma in the study eye 5. Shaffer grade ≥ III in all four angle quadrants in the study eye 6. Subject is treated with 0 to 5 hypotensive medications in the study eye 7. Subject is able and willing to attend all scheduled follow-up exams 8. Subject understands and signs the informed consent
Key exclusion criteria (19 listed)
- 1. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye 2. Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the Minimally Invasive Nasal Trabeculostomy procedure or the study eye is pseudophakic with posterior chamber intraocular lens (PCIOL) 3. Congenital or developmental glaucoma in either eye 4. Fixation threatening visual-field defects or IOP ≥40 mmHg in the study eye
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 |
|---|---|---|
| MINTMechanical rotation of the Surgical Device is achieved by the rotating system (i.e., Activation Device), which is comprised of: (1) Controller which dictates the activation pulse duration, the rotations per minute (RPM) and the forwards and backwards movement of the micro trephine; (2) Motor; and (3) Footswitch. | Device | single-arm study with intra-subject comparisons |
Primary outcome
Proportion of subjects achieved a 20% or greater reduction in IOP from Baseline on the same or fewer number of medications [time frame: 24 weeks
Time frame: 24 months
• Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or fewer number of medications. Subjects who will undergo a glaucoma-related secondary surgical intervention prior to the 24 weeks visit will be considered failures in the analysis.
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 12 Mar 2024.
- Derived from this study: PubMed 41446893Voskanyan L, Miroyan H, Papoyan V, Babayan H, Grover DS. Performance and Safety of Minimally Invasive Nasal Trabeculostomy (MINT) in Open-Angle Glaucoma: A 12-month Open-Label Study on Patients with No Other Glaucoma Surgeries. Clin Ophthalmol. 2025 Dec 19;19:4841-4853. doi: 10.2147/OPTH.S538801. eCollection 2025.
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 in people with This Study is Obtained Under Inclusion/ Exclusion Criteria, 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 1 inclusion and 19 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 12 Mar 2024. 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?
Proportion of subjects achieved a 20% or greater reduction in IOP from Baseline on the same or fewer number of medications [time frame: 24 weeks (time frame: 24 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 NCT05638906, 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 12 Mar 2024; AzTrials last refreshed its copy on 4 Nov 2026.