MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications (STAR-I)

iSTAR Medical

Status: Completed

Conditions: Open Angle Glaucoma

Treatments: Device: MINIject implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03193736

ISM04

Details and patient eligibility

About

The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
• Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
• Glaucoma not adequately controlled

Exclusion criteria

• Diagnosis of glaucoma other than open angle glaucoma
• Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
• Neovascular glaucoma in the study eye
• Prior glaucoma surgery in the study eye
• Clinically significant corneal disease
• Patients with poor vision

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

implant

Experimental group

Treatment:

Device: MINIject implant