Minimally invasive procedure to lower eye pressure in glaucoma patients

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

This study is testing a new, less invasive eye surgery to see if it can lower eye pressure in glaucoma patients who aren't getting enough help from their medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 129 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Sanoculis Ltd (industry)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06313749 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the Minimally Invasive Micro Sclerostomy (MIMS®) procedure in reducing intraocular pressure in patients with primary open angle glaucoma who have not achieved adequate control despite using multiple medications. Participants will undergo the MIMS® procedure and will be monitored for 12 months to assess the surgical success rate compared to traditional trabeculectomy with Mitomycin-C. The study is designed as a single-arm trial, focusing on demonstrating non-inferiority of the MIMS® approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 85 with inadequately controlled primary open angle glaucoma despite polypharmacy.

Not a fit: Patients with well-controlled glaucoma or those who have had prior conjunctival-sparing glaucoma procedures within the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could provide a safer and more effective treatment option for patients with difficult-to-control glaucoma.

How similar studies have performed: Other studies have shown promising results with minimally invasive glaucoma surgeries, suggesting potential for success with this approach.

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

Where this trial is running

Dallas, Texas

• Glaucoma Associates of Texas — Dallas, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Khan Lau, OD

Conditions: Primary Open Angle Glaucoma, Open Angle Glaucoma, Polypharmacy, Intraocular Pressure, MIMS, Minimally Invasive Glaucoma Surgery, MIGS, MTMT