NCT07358650

Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma

A Multicenter, First-in-Human Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Hexiris Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

It is an interventional study for the treatment of Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) system. This medical device includes a sclerectomy punch and injector assembly. It is a multicenter, open-label, non-randomized, single-arm study. Adults aged 40 years or more will be enrolled if the POAG is inadequately controlled by topical drug therapies. Only one eye per subject will be treated. The study will be performed on the first five patients in the operating room and the subsequent 20 patients will be treated under a slit-lamp in an aseptic environment (external patient clinic).Once treated with the MIST device, patients will return the next day, 1 week later and 1, 2, 3, 6, 9 and 12 months later. During these follow-up visits, the ophthalmologist will examine the eye and take measurements of the intraocular pressure.

Detailed description

It is an interventional study for the treatment of Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) system in adults aged 40 years or more. The primary goal of this new treatment is to reduce intraocular pressure in the affected eye. The first five cases will be performed in the operating room. Safety data, including any serious adverse events occurring on Day 0 (surgery), will be reviewed by the safety monitor, who will issue a formal decision indicating whether the study may transition to the slit lamp or must continue in the operating room for the 20 subsequent patients. The surgical technique is performed ab externo under topical anesthesia at the slit lamp. Patients will be treated using the Hexiris MIST device along with a subconjunctival injection of mitomycin C (0.02-0.04%) using a sterile technique. There is postoperative care using topical antibiotics and steroids. The follow-up duration is 12-months post treatment with the Hexiris MIST device.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Hexiris Microinvasive Scleral Trephine (MIST)	The punch needle of the Hexiris MIST device was designed to be injected securely into the conjunctiva/sclera and remove a core of tissue, creating a channel in the sclera of the eye for reduction of IOP.

Timeline

• Start date: 2026-01-15
• Primary completion: 2027-02-15
• Completion: 2027-03-15
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

5 sites across 1 country: Canada