This Study is Conducted Under Inclusion/ Exclusion CriteriaNCT05638321
Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure - Performance Evaluation Study
A study testing MIMS in people with This Study is Conducted Under Inclusion/ Exclusion Criteria, run by Sanoculis Ltd at 1 site in Armenia.
Trial summary
Minimally Invasive Micro Sclerostomy (MIMS®) device is intended for the reduction of elevated Intraocular Pressure (IOP). MIMS® is a powered surgical device, designed to create a drainage channel of 100 microns diameter at the sclera-corneal junction and extending from the anterior chamber to the interface between the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- This Study is Conducted Under Inclusion/ Exclusion Criteria
- What is being tested?
- MIMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteArmenia
- Study dates
- 11 Apr 2022to 12 Mar 2024
- 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
- Unsatisfactory IOP level, i.e., IOP ≥21 mmHg, at the screening visit in the study eye
- 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)
- Optic nerve appearance characteristic of glaucoma in the study eye
- Shaffer grade ≥ III in all four angle quadrants in the study eye
- Subject is treated with 0 to 5 hypotensive medications in the study eye
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- Subject is able and willing to attend all scheduled follow-up exams
- Subject understands and signs the informed consent
- In addition, subjects meeting the following criterion will be considered for enrolment into Treatment Arm 2 or Treatment Arm 3 of the trial:
- Subject with refractory glaucoma, defined as prior failure of filtering procedure and/or uncontrolled IOP on maximally tolerated medical therapy (i.e., ≥ 4 classes of topical IOP-lowering medications, or fewer in the case of tolerability or efficacy issues) . Specifically, subjects who:
- Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery);
- Have neovascular glaucoma;
- Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for an eye with uncomplicated primary open angle glaucoma
Who cannot join
- Exclusion Criteria
- Subjects presenting 1 or more of the following criteria will not be enrolled in any of the treatment arms of the trial:
- Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the Minimally Invasive Nasal Trabeculostomy System procedure or the study eye is pseudophakic with posterior chamber intraocular lens (PCIOL)
- Congenital or developmental glaucoma in either eye
- Fixation threatening visual-field defects or IOP ≥40 mmHg in the study eye
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- 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 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
- 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
- Additionally, subjects presenting 1 or more of the following criteria will not be enrolled in Treatment Arm 1 of the trial:
- Prior glaucoma filtering surgery, such as trabeculectomy, in the study eye
- Prior cilioablative procedure in the study eye
Trial locations and contacts
1 site in 1 country.
About this study
Minimally Invasive Micro Sclerostomy (MIMS®) device is intended for the reduction of elevated Intraocular Pressure (IOP).
MIMS® is a powered surgical device, designed to create a drainage channel of 100 microns diameter at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjunctival space), at the inferonasal quadrant of the eye (i.e., inferonasal sclerostomy).
The drainage channel is created by a sterile surgical device made of stainless steel and plastic, which is coupled to a rotating system. The surgical device consists of stainless steel micro trephine, covered by a small needle and rotating mechanism behind it. Mechanical rotation of the surgical device is achieved by the rotating system which is comprised of a 1) Controller which dictates the activation pulse duration and RPM, 2) a Motor, and 3) Footswitch.
- Being tested
- MIMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIMSDevice
sterile surgical device made of stainless steel and plastic, which is coupled to a rotating system. The surgical device consists of stainless steel micro trephine, covered by a small needle and rotating mechanism behind it. Mechanical rotation of the surgical device is achieved by the rotating system which is comprised of a 1) Controller which dictates the activation pulse duration and RPM, 2) a Motor, and 3) Footswitch.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | 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: MIMS |
| Treatment Arm 2 | Experimental | Eyes of subjects with uncontrolled (IOP > 20 mmHg) open-angle glaucoma (OAG), who failed prior filtering procedure or had uncontrolled IOP on tolerated glaucoma medications [Treatment Arm 2 and Treatment Arm 3]. Receives: Device: MIMS |
| Treatment Arm 3 | Experimental | Two (2) inferonasal sclerostomies will be performed by the MIMS® system in the eyes of subjects who failed prior filtering procedure or had uncontrolled IOP on tolerated glaucoma medications (i.e., refractory glaucoma). Receives: Device: MIMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or fewer number of medications at 24-week visit
- 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 reoperation for glaucoma prior to the 24 weeks visit will be considered failures in the analysis.
Measured: 24 weeks
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 completion7 Feb 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study is Conducted 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 83 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
- NCT05638321
- Sponsor's protocol ID
- MMS EEU-5
- Status last verified
- Jan 2023
- First submitted
- 27 Nov 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Micro Sclerostomy (MIMS®) Inferonasal Procedure - Performance Evaluation Study
- ClinicalTrials.gov ID
- NCT05638321
- Acronym / sponsor ID
- MMS EEU-5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Sanoculis LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 12 Mar 2024 (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 Micro Sclerostomy (MIMS®) device is intended for the reduction of elevated Intraocular Pressure (IOP).
MIMS® is a powered surgical device, designed to create a drainage channel of 100 microns diameter at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjunctival space), at the inferonasal quadrant of the eye (i.e., inferonasal sclerostomy).
The drainage channel is created by a sterile surgical device made of stainless steel and plastic, which is coupled to a rotating system. The surgical device consists of stainless steel micro trephine, covered by a small needle and rotating mechanism behind it. Mechanical rotation of the surgical device is achieved by the rotating system which is comprised of a 1) Controller which dictates the activation pulse duration and RPM, 2) a Motor, and 3) Footswitch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Device: MIMSEyes of subjects with uncontrolled (IOP > 20 mmHg) open-angle glaucoma (OAG), where IOP is not controlled when using maximum tolerated glaucoma medications |
| Treatment Arm 2 | Experimental | Device: MIMSEyes of subjects with uncontrolled (IOP > 20 mmHg) open-angle glaucoma (OAG), who failed prior filtering procedure or had uncontrolled IOP on tolerated glaucoma medications [Treatment Arm 2 and Treatment Arm 3]. |
| Treatment Arm 3 | Experimental | Device: MIMSTwo (2) inferonasal sclerostomies will be performed by the MIMS® system in the eyes of subjects who failed prior filtering procedure or had uncontrolled IOP on tolerated glaucoma medications (i.e., refractory glaucoma). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female ≥ 18 years to ≤ 85 years old
- Unsatisfactory IOP level, i.e., IOP ≥21 mmHg, at the screening visit in the study eye
- 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)
- Optic nerve appearance characteristic of glaucoma in the study eye
- Shaffer grade ≥ III in all four angle quadrants in the study eye
Key exclusion criteria (26 listed)
- Exclusion Criteria
- Subjects presenting 1 or more of the following criteria will not be enrolled in any of the treatment arms of the trial:
- Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the Minimally Invasive Nasal Trabeculostomy System procedure or the study eye is pseudophakic with posterior chamber intraocular lens (PCIOL)
- Congenital or developmental glaucoma in either 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 |
|---|---|---|
| MIMSsterile surgical device made of stainless steel and plastic, which is coupled to a rotating system. The surgical device consists of stainless steel micro trephine, covered by a small needle and rotating mechanism behind it. Mechanical rotation of the surgical device is achieved by the rotating system which is comprised of a 1) Controller which dictates the activation pulse duration and RPM, 2) a Motor, and 3) Footswitch. | Device | Treatment Arm 1, Treatment Arm 2, Treatment Arm 3 |
Primary outcome
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or fewer number of medications at 24-week visit
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 reoperation for glaucoma 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.
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 This Study is Conducted 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 13 inclusion and 26 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 achieving a 20% or greater reduction in IOP from baseline on the same or fewer number of medications at 24-week visit (time frame: 24 weeks). 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 12 Mar 2024.