Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Minimally Invasive Micro Sclerostomy Device.
- Who it may be relevant to
- Registry conditions: Primary Open Angle Glaucoma, Open Angle Glaucoma. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Minimally Invasive Micro Sclerostomy 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.
Primary outcome measures
- Surgical success rate of the MIMS® device/procedure at 12 months after surgery [Time frame: 12 months]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Glaucoma Associates of Texas — Dallas
Identifiers
NCT: NCT06313749 · MMS-US-1