Open Angle GlaucomaNCT06614218
MIMS® Retrospective Chart Review
An observational study of Open Angle Glaucoma, run by Sanoculis Ltd at 1 site in Armenia.
Trial summary
This is a post-market clinical follow-up, retrospective chart review of MIMS® surgical procedures conducted during time period between Sep 2023 and April 2025. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Minimally Invasive Micro Sclerostomy
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteArmenia
- Study dates
- 27 Sep 2023to 30 Jul 2025
- 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 40 to 85 years
- All sexes
- Adult, Older adult
Study population: The study population consists of subjects of Armenian descent that were treated with the MIMS® Device as a standalone procedure between 27 Sep 2023 and 30 April 2024.
Who may be able to join
- Eye treated with MIMS® Device as a standalone procedure
- MIMS® surgery was performed between 27 Sep 2023 and 30 April 2024
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Micro Sclerostomy (MIMS®) Retrospective Chart Review
This is a post-market clinical follow-up, retrospective chart review of MIMS® surgical procedures conducted during time period between Sep 2023 and April 2025.
- Conditions
- Open Angle Glaucoma
- Being tested
- Minimally Invasive Micro Sclerostomy
- Keywords
- Polypharmacy, Intraocular Pressure, MIMS, Minimally Invasive Glaucoma Surgery, MIGS, MTMT, Trabeculectomy, Sclerostomy
- 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 SclerostomyDevice
Also called MIMS
The MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the eye.
| Study group | Role | What they receive |
|---|---|---|
| MIMS Surgery Cohort | This cohort consists subjects treated with MIMS® Device as a standalone procedure during time period (27 Sep 2023 - 31 May 2025), and with documented post-operative follow-up available in the medical charts. Receives: Device: Minimally Invasive Micro Sclerostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IOP from medicated baseline at 12 months post-MIMS® surgery
Measured: Medicated baseline at 12 months post-MIMS® surgery
Change in the number of topical IOP-lowering medications from medicated baseline at 12 months post-MIMS® surgery
Measured: Medicated baseline at 12 months post-MIMS® surgery
Success rate at 12 months post-MIMS® surgery
Measured: 12 months post-MIMS® surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start27 Sep 2023
- Primary completion25 Apr 2024
- Study completion30 Jul 2025
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 34 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
- NCT06614218
- Sponsor's protocol ID
- MMS-EEU-9
- Status last verified
- Jul 2025
- First submitted
- 24 Sep 2024
- Last updated
- 15 Oct 2026
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Micro Sclerostomy (MIMS®) Retrospective Chart Review
- ClinicalTrials.gov ID
- NCT06614218
- Acronym / sponsor ID
- MMS-EEU-9
- Conditions
- Open Angle Glaucoma
- Keywords
- Polypharmacy, Intraocular Pressure, MIMS, Minimally Invasive Glaucoma Surgery, MIGS, MTMT, Trabeculectomy, Sclerostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sanoculis LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 26 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 is a post-market clinical follow-up, retrospective chart review of MIMS® surgical procedures conducted during time period between Sep 2023 and April 2025.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIMS Surgery Cohort | – | Device: Minimally Invasive Micro SclerostomyThis cohort consists subjects treated with MIMS® Device as a standalone procedure during time period (27 Sep 2023 - 31 May 2025), and with documented post-operative follow-up available in the medical charts. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of subjects of Armenian descent that were treated with the MIMS® Device as a standalone procedure between 27 Sep 2023 and 30 April 2024.
Key inclusion criteria (2 listed)
- Eye treated with MIMS® Device as a standalone procedure
- MIMS® surgery was performed between 27 Sep 2023 and 30 April 2024
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 SclerostomyAlso: MIMSThe MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the eye. | Device | MIMS Surgery Cohort |
Primary outcome
Change in IOP from medicated baseline at 12 months post-MIMS® surgery
Time frame: Medicated baseline at 12 months post-MIMS® surgery
Change in the number of topical IOP-lowering medications from medicated baseline at 12 months post-MIMS® surgery
Time frame: Medicated baseline at 12 months post-MIMS® surgery
Success rate at 12 months post-MIMS® surgery
Time frame: 12 months post-MIMS® surgery
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?
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 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?
Change in IOP from medicated baseline at 12 months post-MIMS® surgery (time frame: Medicated baseline at 12 months post-MIMS® surgery). The study lists 3 primary outcomes in all. 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.