Open Angle GlaucomaNCT06612346
Minimally Invasive Nasal Trabeculostomy: Long-Term Follow-Up Extension Study
An observational study of Open Angle Glaucoma, run by Sanoculis Ltd at 1 site in Armenia.
Trial summary
This study is a follow-up extension study conducted in continuation of the prior MINT study (MMS-EEU-4), in which the long-term (i.e., 18, 24 months) clinical outcomes of Minimally Invasive Nasal Trabeculostomy (MINT) will be explored. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Minimally Invasive Micro Trabeculostomy
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteArmenia
- Study dates
- 4 Nov 2022to 31 Dec 2024
- Phase
- Observational
- 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
Study population: The study population consists of subjects of Armenian descent that underwent the MINT procedure.
Who may be able to join
- Male or female ≥ 18 years to ≤ 85 years old
- Subject who underwent MINT, and surgery was performed not earlier than 18 months from enrollment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a follow-up extension study conducted in continuation of the prior MINT study (MMS-EEU-4), in which the long-term (i.e., 18, 24 months) clinical outcomes of Minimally Invasive Nasal Trabeculostomy (MINT) will be explored.
- Conditions
- Open Angle Glaucoma
- Being tested
- Minimally Invasive Micro Trabeculostomy
- Keywords
- MINT, Trabeculostomy, Minimally Invasive Glaucoma Surgery, MIGS, Intraocular Pressure
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Micro TrabeculostomyDevice
Also called MINT
The MINT system is a surgical device designed to create a trabeculostomy within the eye.
| Study group | Role | What they receive |
|---|---|---|
| MINT Surgery Cohort | Cohort that includes subjects that have undergone the MINT surgical procedure. Receives: Device: Minimally Invasive Micro Trabeculostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure Measurement
Observed IOP at long-term timepoints
Measured: 18 months +/- 2 months post-MINT surgery from previous study (MMS-EEU-4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start4 Nov 2022
- Primary completion22 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 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
- NCT06612346
- Sponsor's protocol ID
- MMS-EEU-7
- Status last verified
- Jan 2025
- First submitted
- 27 Aug 2024
- Last updated
- 10 Jan 2025
- Results posted
- 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 10 Jan 2025. 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
- NCT06612346
- Acronym / sponsor ID
- MMS-EEU-7
- Conditions
- Open Angle Glaucoma
- Keywords
- MINT, Trabeculostomy, Minimally Invasive Glaucoma Surgery, MIGS, Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sanoculis LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 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.
This study is a follow-up extension study conducted in continuation of the prior MINT study (MMS-EEU-4), in which the long-term (i.e., 18, 24 months) clinical outcomes of Minimally Invasive Nasal Trabeculostomy (MINT) will be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MINT Surgery Cohort | – | Device: Minimally Invasive Micro TrabeculostomyCohort that includes subjects that have undergone the MINT surgical procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of subjects of Armenian descent that underwent the MINT procedure.
Key inclusion criteria (2 listed)
- Male or female ≥ 18 years to ≤ 85 years old
- Subject who underwent MINT, and surgery was performed not earlier than 18 months from enrollment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Minimally Invasive Micro TrabeculostomyAlso: MINTThe MINT system is a surgical device designed to create a trabeculostomy within the eye. | Device | MINT Surgery Cohort |
Primary outcome
Intraocular Pressure Measurement
Time frame: 18 months +/- 2 months post-MINT surgery from previous study (MMS-EEU-4).
Observed IOP at long-term timepoints
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 10 Jan 2025.
- 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?
An observational study of Open Angle Glaucoma, 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 2 inclusion and 0 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 10 Jan 2025. 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?
Intraocular Pressure Measurement (time frame: 18 months +/- 2 months post-MINT surgery from previous study (MMS-EEU-4).). 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 10 Jan 2025.