Open Angle GlaucomaNCT06577857
Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study
An observational study of Open Angle Glaucoma, run by Sanoculis Ltd at 1 site in Armenia.
Trial summary
A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5). 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?
- Inferonasal Minimally Invasive Micro Sclerostomy
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteArmenia
- Study dates
- 4 Nov 2022to 30 Jan 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 underwent the MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment.
Who may be able to join
- 1. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure: Long-Term Follow-Up Extension Study
A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).
- Conditions
- Open Angle Glaucoma
- Being tested
- Inferonasal Minimally Invasive Micro Sclerostomy
- Keywords
- Intraocular Pressure, MIMS, Inferonasal, Minimally Invasive Glaucoma Surgery, Trabeculectomy, Sclerostomy, MIGS
- 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.
Inferonasal Minimally Invasive Micro SclerostomyDevice
Also called Inferonasal MIMS
The Inferonasal MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the inferonasal quadrant of the eye.
| Study group | Role | What they receive |
|---|---|---|
| Inferonasal MIMS Surgery Cohort | Cohort that includes subjects that have undergone the MIMS® inferonasal surgery. Receives: Device: Inferonasal Minimally Invasive Micro Sclerostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure Change (Baseline to 24 months)
Change in IOP from medicated baseline to 24 months post-MIMS® surgery
Measured: Baseline to 24 months post-MIMS® surgery
Intraocular Pressure Change (Baseline to 30 months)
Change in IOP from medicated baseline to 30 months post-MIMS® surgery
Measured: Baseline to 30 months post-MIMS® surgery
Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months)
Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery
Measured: Medicated baseline to 24 months post-MIMS® surgery
Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months)
Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery
Measured: Medicated baseline to 30 months post-MIMS® surgery
Surgery Success Rate (24 months)
Success rate 24 months post-MIMS® surgery
Measured: 24 months post-MIMS® surgery
Surgery Success Rate (30 months)
Success rate 30 months post-MIMS® surgery
Measured: 30 months post-MIMS® surgery
Secondary outcomes (2)
Postoperative Complication Safety Outcomes
Late (greater than 12 months) postoperative complications
Measured: Baseline to 30 months post-MIMS® surgery
Interventional Safety Outcomes
Late (greater than 12 months) postoperative interventions
Measured: Baseline to 30 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 posted29 Aug 2024
- Study start4 Nov 2022
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Why it stopped: The study was terminated following completion of the Week 24 visit. The Week 30 follow-up visit was canceled due to internal company reasons.
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
- 44 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
- NCT06577857
- Sponsor's protocol ID
- MMS-EEU-8
- Status last verified
- Jan 2025
- First submitted
- 27 Aug 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®) Inferonasal Procedure: Long-Term Follow-Up Extension Study
- ClinicalTrials.gov ID
- NCT06577857
- Acronym / sponsor ID
- MMS-EEU-8
- Conditions
- Open Angle Glaucoma
- Keywords
- Intraocular Pressure, MIMS, Inferonasal, Minimally Invasive Glaucoma Surgery, Trabeculectomy, Sclerostomy, MIGS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated following completion of the Week 24 visit. The Week 30 follow-up visit was canceled due to internal company reasons.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sanoculis LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 29 Aug 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.
A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inferonasal MIMS Surgery Cohort | – | Device: Inferonasal Minimally Invasive Micro SclerostomyCohort that includes subjects that have undergone the MIMS® inferonasal surgery. |
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 underwent the MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment.
Key inclusion criteria (1 listed)
- 1. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 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 |
|---|---|---|
| Inferonasal Minimally Invasive Micro SclerostomyAlso: Inferonasal MIMSThe Inferonasal MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the inferonasal quadrant of the eye. | Device | Inferonasal MIMS Surgery Cohort |
Primary outcome
Intraocular Pressure Change (Baseline to 24 months)
Time frame: Baseline to 24 months post-MIMS® surgery
Change in IOP from medicated baseline to 24 months post-MIMS® surgery
Intraocular Pressure Change (Baseline to 30 months)
Time frame: Baseline to 30 months post-MIMS® surgery
Change in IOP from medicated baseline to 30 months post-MIMS® surgery
Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months)
Time frame: Medicated baseline to 24 months post-MIMS® surgery
Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery
Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months)
Time frame: Medicated baseline to 30 months post-MIMS® surgery
Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery
Surgery Success Rate (24 months)
Time frame: 24 months post-MIMS® surgery
Success rate 24 months post-MIMS® surgery
Surgery Success Rate (30 months)
Time frame: 30 months post-MIMS® surgery
Success rate 30 months post-MIMS® surgery
2 secondary outcomes
Postoperative Complication Safety Outcomes
Time frame: Baseline to 30 months post-MIMS® surgery
Interventional Safety Outcomes
Time frame: Baseline to 30 months post-MIMS® surgery
Results and safety
The study was stopped early (reason given: The study was terminated following completion of the Week 24 visit. The Week 30 follow-up visit was canceled due to internal company reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Open Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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 1 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: stopped early, 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 was stopped early (reason given: The study was terminated following completion of the Week 24 visit. The Week 30 follow-up visit was canceled due to internal company reasons.). Results are not available in the source record.
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 Change (Baseline to 24 months) (time frame: Baseline to 24 months post-MIMS® surgery). The study lists 6 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.