NCT06313749

Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Sanoculis Ltd · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-03-15
• Last updated: 2024-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study