Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma
Recruiting
N/A
Interventional Study
Primary Open Angle Glaucoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 40 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 25 (estimated)
- Sponsor
- Hexiris Inc · Industry
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About This Trial
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.…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults ≥ 40 years with uncontrolled mild to moderate POAG.
* IOP ≥ 18 mmHg on ≥1 topical IOP-lowering medications.
* Open angle on gonioscopy
* Clear cornea and healthy ocular surface
* Capable of giving informed consent, willingness to participate in the trial, and adhering t…
Contacts