Primary Open Angle GlaucomaNCT06313749
Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
A study testing Minimally Invasive Micro Sclerostomy Device in people with Primary Open Angle Glaucoma and Open Angle Glaucoma, run by Sanoculis Ltd at 1 site in United States.
Trial summary
The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Open Angle Glaucoma
- What is being tested?
- Minimally Invasive Micro Sclerostomy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to Dec 2025
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, ≥ 40 years to ≤ 85 years old
- Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy
- Primary open angle glaucoma diagnosis based on:
- Visual field mean deviation of -3dB or worse and
- Glaucomatous optic nerve damage as evidenced by optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos
- Presence of healthy, free, and mobile conjunctiva in the target quadrant
Show all 9Show fewer
- Prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy [GATT])
- Subject is able and willing to attend all scheduled follow-up exams
- Subject understands and signs the informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Glaucoma Associates of Texas
Dallas, Texas, 75231
Davinder Grover, MD, dgrover@glaucomaassociates.com
About this study
Official title: An Observer-Masked, Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy.
Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C.
- Conditions
- Primary Open Angle Glaucoma, Open Angle Glaucoma
- Being tested
- Minimally Invasive Micro Sclerostomy Device
- Keywords
- Open Angle Glaucoma, Polypharmacy, Intraocular Pressure, MIMS, Minimally Invasive Glaucoma Surgery, MIGS, MTMT
- 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 Sclerostomy DeviceDevice
Also called MIMS® Device
During this clinical trial, the Minimally Invasive Micro Sclerostomy (MIMS®) procedure will be performed by investigators using the proprietary MIMS® device developed by Sanoculis Ltd.
| Study group | Role | What they receive |
|---|---|---|
| MIMS® Device/Procedure Arm | Experimental | Arm which includes subjects undergoing the MIMS® surgical procedure using the proprietary MIMS® device developed by Sanoculis Ltd. Receives: Device: Minimally Invasive Micro Sclerostomy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success rate of the MIMS® device/procedure at 12 months after surgery
Definition of Surgical Success: the subject's eye, after having the MIMS® procedure:
- Achieved 20% or more reduction in average diurnal IOP from baseline at 12 months after surgery; AND
- Using the same number or fewer topical IOP lowering medications
Measured: 12 months
Secondary outcomes (7)
Exploratory Effectiveness Endpoint 1
Change in IOP (mmHg) from baseline to 12 months follow-up
Measured: 12 months
Exploratory Effectiveness Endpoint 2
Change in IOP (% change) from baseline to 12 months follow-up
Measured: 12 months
Exploratory Effectiveness Endpoint 3
Change in the number of IOP lowering topical medications from screening to 12 months follow-up
Measured: 12 months
Exploratory Effectiveness Endpoint 4
Change in number (% change) of IOP lowering topical medications from screening to 12 months follow-up
Measured: 12 months
Safety Outcome 1
Incidence of ocular adverse events in the study eye (overall and related to MIMS® device/procedure) throughout the follow-up period
Measured: 12 months
Safety Outcome 2
Biomicroscopic slit lamp and ophthalmoscopy findings
Measured: 12 months
Safety Outcome 3
Preservation of Best-Corrected Visual Acuity (BCVA)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jun 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanoculis Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313749
- Sponsor's protocol ID
- MMS-US-1
- Status last verified
- Aug 2024
- First submitted
- 2 Mar 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer-Masked, Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
- ClinicalTrials.gov ID
- NCT06313749
- Acronym / sponsor ID
- MMS-US-1
- Conditions
- Primary Open Angle Glaucoma, Open Angle Glaucoma
- Keywords
- Open Angle Glaucoma, Polypharmacy, Intraocular Pressure, MIMS, Minimally Invasive Glaucoma Surgery, MIGS, MTMT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Sanoculis LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Mar 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.
The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy.
Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIMS® Device/Procedure Arm | Experimental | Device: Minimally Invasive Micro Sclerostomy DeviceArm which includes subjects undergoing the MIMS® surgical procedure using the proprietary MIMS® device developed by Sanoculis Ltd. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, ≥ 40 years to ≤ 85 years old
- Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy
- Primary open angle glaucoma diagnosis based on:
- Presence of healthy, free, and mobile conjunctiva in the target quadrant
- Prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy [GATT])
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 Sclerostomy DeviceAlso: MIMS® DeviceDuring this clinical trial, the Minimally Invasive Micro Sclerostomy (MIMS®) procedure will be performed by investigators using the proprietary MIMS® device developed by Sanoculis Ltd. | Device | MIMS® Device/Procedure Arm |
Primary outcome
Surgical success rate of the MIMS® device/procedure at 12 months after surgery
Time frame: 12 months
Definition of Surgical Success: the subject's eye, after having the MIMS® procedure: 1. Achieved 20% or more reduction in average diurnal IOP from baseline at 12 months after surgery; AND 2. Using the same number or fewer topical IOP lowering medications
7 secondary outcomes
Exploratory Effectiveness Endpoint 1
Time frame: 12 months
Exploratory Effectiveness Endpoint 2
Time frame: 12 months
Exploratory Effectiveness Endpoint 3
Time frame: 12 months
Exploratory Effectiveness Endpoint 4
Time frame: 12 months
Safety Outcome 1
Time frame: 12 months
Safety Outcome 2
Time frame: 12 months
Safety Outcome 3
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Micro Sclerostomy Device in people with Primary Open Angle Glaucoma and Open Angle Glaucoma, run by Sanoculis Ltd at 1 site in United States.
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 9 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: status not confirmed, as of the sponsor's last update on 7 Aug 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khan Lau, OD (8082862666, khan@sanoculis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success rate of the MIMS® device/procedure at 12 months after surgery (time frame: 12 months). 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 7 Aug 2024.