GlaucomaNCT07051174
The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP): The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP)
A study testing MIMS in people with Glaucoma, run by Sanoculis Ltd at 1 site in Armenia.
Trial summary
No new investigational device is used in this study. This study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System [MIMS® System] [CE Marked… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- MIMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteArmenia
- Study dates
- 11 Apr 2022to 27 Oct 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
- Male or female ≥ 18 years to ≤ 85 years old
- Subject who underwent either standalone MIMS® surgery or MIMS® surgery in combination with phacoemulsification, in continuation of the previous clinical investigation with the MIMS® device (see: STUDY ID: MMS EEU-1), and surgery was performed not earlier than 2 years from enrollment
- Subject who is considered complete success (i.e., 20% or greater reduction in IOP from Baseline on no medications) and qualified success (i.e., 20% or greater reduction in IOP from Baseline on the same or less number of medications) or failure with IOP >21mmHg with no medications at 1 year post MIMS® surgery (see: STUDY ID: MMS EEU-1)
- Subject who is able and willing to attend all scheduled assessments
- Subject understands and signs the informed consent
Who cannot join
- Subject who was considered failure at 1 year after the MIMS® surgery
- Any subject with major protocol deviation from the prior MIMS® study (ID: MMS EEU-1)
- Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye, since the MIMS® surgery in the study eye
- Any ocular disease in the 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
- Any ocular surgery since the MIMS® surgery in the study eye
- Severe trauma in the study eye since the MIMS® surgery in the study eye
- Current participation or participation in another investigational drug or device clinical trial within the last 30 days before enrollment in the study
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Micro Sclerostomy System - Long- Term Follow-Up Extension Study
No new investigational device is used in this study. This study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System [MIMS® System] [CE Marked device] are evaluated.
- Conditions
- Glaucoma
- Being tested
- MIMS
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIMSDiagnostic test
This study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System [MIMS® System] [CE Marked device] are evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: MIMS® Minimally Invasive Trabeculostomy in OAG Patients (36-Month Follow-Up) | Experimental | This follow-up extension study is aimed to monitor the long-term IOP-lowering performance/efficacy and safety of the MIMS® procedure in open angle glaucoma eyes. Receives: Diagnostic Test: MIMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed IOP at Long- Term ( >2 Years) post-MIMS® surgery:
- IOP will be measured for subjects who have completed the MIMS® surgery and no earlier than 2 years from the procedure.
Measured: 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery
Secondary outcomes (1)
• IOP Levels at the following time points:
IOP will be measured for subjects who have completed the MIMS® surgery and assessed at least one of the following visits (the data from more than one visit will be also collected):
28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery
Measured: 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 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 posted4 Jul 2025
- Study start11 Apr 2022
- Primary completion30 Aug 2023
- Study completion27 Oct 2023
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 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
- NCT07051174
- Sponsor's protocol ID
- MMS EEU-3
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Micro Sclerostomy System - Long- Term Follow-Up Extension Study
- ClinicalTrials.gov ID
- NCT07051174
- Acronym / sponsor ID
- MMS EEU-3
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Sanoculis LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 4 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.
No new investigational device is used in this study. This study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System [MIMS® System] [CE Marked device] are evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: MIMS® Minimally Invasive Trabeculostomy in OAG Patients (36-Month Follow-Up) | Experimental | Diagnostic Test: MIMSThis follow-up extension study is aimed to monitor the long-term IOP-lowering performance/efficacy and safety of the MIMS® procedure in open angle glaucoma eyes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥ 18 years to ≤ 85 years old
- Subject who underwent either standalone MIMS® surgery or MIMS® surgery in combination with phacoemulsification, in continuation of the previous clinical investigation with the MIMS® device (see: STUDY ID: MMS EEU-1), and surgery was performed not earlier than 2 years from enrollment
- Subject who is considered complete success (i.e., 20% or greater reduction in IOP from Baseline on no medications) and qualified success (i.e., 20% or greater reduction in IOP from Baseline on the same or less number of medications) or failure with IOP >21mmHg with no medications at 1 year post MIMS® surgery (see: STUDY ID: MMS EEU-1)
- Subject who is able and willing to attend all scheduled assessments
- Subject understands and signs the informed consent
Key exclusion criteria (8 listed)
- Subject who was considered failure at 1 year after the MIMS® surgery
- Any subject with major protocol deviation from the prior MIMS® study (ID: MMS EEU-1)
- Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye, since the MIMS® surgery in the study eye
- Any ocular disease in the 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
- Any ocular surgery since the MIMS® surgery 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 |
|---|---|---|
| MIMSThis study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System [MIMS® System] [CE Marked device] are evaluated. | Diagnostic test | Intervention Arm: MIMS® Minimally Invasive Trabeculostomy in OAG Patients (36-Month Follow-Up) |
Primary outcome
Observed IOP at Long- Term ( >2 Years) post-MIMS® surgery:
Time frame: 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery
• IOP will be measured for subjects who have completed the MIMS® surgery and no earlier than 2 years from the procedure.
1 secondary outcome
• IOP Levels at the following time points:
Time frame: 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 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 4 Jul 2025.
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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 MIMS in people with 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 5 inclusion and 8 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 4 Jul 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?
Observed IOP at Long- Term ( >2 Years) post-MIMS® surgery: (time frame: 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® 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 4 Jul 2025.