NCT07009236

A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma

A Multi-center, Prospective, Cohort Expansion Clinical Study Evaluating the Safety, Usability, Implantation Accuracy and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma (STAR VII Study)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: iSTAR Medical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).

Conditions

• Glaucoma

Interventions

Type	Name	Description
DEVICE	MIGS	Implant MINIject S+ in supraciliary space

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

3 sites across 2 countries: Honduras, United Kingdom