MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

iSTAR Medical

Status: Completed

Conditions: Open Angle Glaucoma

Treatments: Device: MINI SO636; Device: MINI DO636

Study type: Interventional

Funder types: Industry

Identifiers

NCT03374553

ISM05

Details and patient eligibility

About

The study will evaluate the efficacy and safety of MINIject 636 and 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: 52 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: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

MINIject DO Integrated System CS636 (MINI DO636)

Experimental group

Description:

MINIject 636 implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. In this arm the implant is placed using Dual Operator Delivery Tool (DODT).

Treatment:

Device: MINI DO636

MINIject SO Integrated System CS636 (MINI SO636)

Experimental group

Description:

MINIject 636 implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. In this arm the implant is placed using Single Operator Delivery Tool (SODT).

Treatment:

Device: MINI SO636