Hydrus Microstent for Refractory Open-Angle Glaucoma (SUMMIT)

Ivantis

Status: Completed

Conditions: Open-angle Glaucoma

Treatments: Procedure: Ophthalmic surgery; Device: Hydrus Microstent

Study type: Interventional

Funder types: Industry

Identifiers

NCT03267134

CP 16-001

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.

Full description

Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.

Enrollment: 217 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Open-angle glaucoma with optic nerve pathology;
• BCVA of 20/80 or better in study eye;
• Refractory glaucoma;
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma;
• Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma;
• Pre-perimetric glaucoma;
• Ocular hypertension
• Shallow or flat anterior chamber;
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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217 participants in 1 patient group

Hydrus Microstent

Experimental group

Description:

Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted.

Treatment:

Device: Hydrus Microstent

Procedure: Ophthalmic surgery