Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy (NCT06313749)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Glaucoma Associates of Texas — Dallas, Texas
Age range: 40 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Glaucoma Associates of Texas — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (808) 286-2666
Email: khan@sanoculis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Primary Open Angle Glaucoma
- A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX) — Panama City,
- Advanced Glaucoma Progression Study — Los Angeles, California
- Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study — Palo Alto, California
- Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery) — Las Vegas, Nevada
- A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma — Glendale, Arizona
- Hydrus® Microstent New Enrollment Post-Approval Study — Irvine, California
Explore by condition: All Primary Open Angle Glaucoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.