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

N/ACompletedNCT03193736

iSTAR Medical26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Open Angle Glaucoma

Interventions

MINIject implantDEVICE

MINIject implant is used to reduce intra-ocular pressure (IOP) in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Maxivision Eye Hospital

Hyderabad, Telangana, India

Clinica de ojos Orillac-Calvo

Panama City, Panama

Outcomes

Primary Outcomes

Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation

Change of Medicated diurnal IOP \[mmHg\] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication

Time frame: 6 months after implantation surgery

Data from ClinicalTrials.gov

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