← Back to searchRecruitingRecruiting
Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
NCT06313749 · Sanoculis Ltd
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. Male or female, ≥ 40 years to ≤ 85 years old
2. Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy
3. Primary open angle glaucoma diagnosis based on:
1. Visual field mean deviation of -3dB or worse and
2. 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
4. Presence of healthy, free, and mobile conjunctiva in the target quadrant
5. Prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy \[GATT\])
6. Subject is able and willing to attend all scheduled follow-up exams
7. Subject understands and signs the informed consent
Study design
Enrollment target: 129 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-06-01
Estimated completion: 2025-12
Last updated: 2024-08-07
Interventions
Device: Minimally Invasive Micro Sclerostomy Device
Primary outcomes
- • Surgical success rate of the MIMS® device/procedure at 12 months after surgery (12 months)
Sponsor
Sanoculis Ltd · industry
Contacts & investigators
ContactKhan Lau, OD · contact · khan@sanoculis.com · 8082862666
All locations (1)
Glaucoma Associates of TexasRecruiting
Dallas, Texas, United States