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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Eye Care Centre NB
Dieppe, New Brunswick, Canada
RECRUITINGMiramichi EyeNB & Surgical Centres of Excellence
Miramichi, New Brunswick, Canada
RECRUITINGPrism Eye Institute Inc.
Brampton, Ontario, Canada
RECRUITINGInstitut de l'oeil des Laurentides
Boisbriand, Quebec, Canada
RECRUITINGOphthalmology Clinic Bellevue
Montreal, Quebec, Canada
RECRUITINGIntraocular pressure lowering
Mean reduction in IOP (Goldmann applanation tonometry)
Time frame: change from baseline to Month 6
Greater or equal to 20% reduction in intraocular pressure (IOP)
Proportion of patients achieving ≥20% IOP reduction
Time frame: change from baseline to Months 6 and 12.
Surgical success
IOP 6-18 mmHg at Month 12 without additional surgery.
Time frame: at Month 12
concomitant glaucoma medications
Change in the number of glaucoma medications
Time frame: change from baseline at week 1 and Months 1, 2, 3, 6, 9 and 12.
Composite surgical success
IOP ≤ 21 mmHg and ≥20% reduction at Month 12 without additional glaucoma surgery, or clinically significant hypotony.
Time frame: at Month 12
Bleb morphology
Bleb morphology and stability - 4 point grading: healthy; injected; diffused bleb; others.
Time frame: at week 1 and Months 1, 2, 3, 6, 9 and 12.
Corneal thickness
Central corneal thickness (CCT) changes
Time frame: change from baseline to Month 6.
Complications
Incidence of conjunctival erosion, hypotony-related complications (reported separately as numerical hypotony \[IOP ≤ 5 mmHg\] and clinical hypotony with complications).
Time frame: at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Patients requiring Mitomycin C post treatment
Number of patients needing MMC injection after surgery.
Time frame: at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Mitomycin C injection post treatment
Number of MMC injections needed post op per patient.
Time frame: at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Safety - adverse events and device failures
reporting of adverse events and serious adverse events
Time frame: day of surgery and at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
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