Study for reduction of Eye Pressure

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

• Males or females, 18 years of age or older.

• 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 by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg <= IOP <= 35mmHg in the study eye at screening and baseline visits.

• Patients must be willing and able to return for scheduled study-related examinations.

• Patients must provide written informed consent.

Exclusion Criteria

• Diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye.

• Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System.

• Neovascular glaucoma in the study eye.

• Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant.

• Prior glaucoma surgery in the study eye. Patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye are eligible if treatment was performed >= 90 days before screening visit.

• Visual field defect in the 10-degree central field in the study eye.

• Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery.

• Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.

• Pre-existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye.

• Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.

• Pre-existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye.

• Evidence of crystalline lens subluxation or luxation in the study eye.

• Evidence of vitreous loss in the anterior chamber in the study eye.

• Clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye.

• Presence of silicone oil in the study eye.

• Patients treated with systemic acetazolamide within 3 days before screening.

• Patient with poor vision (LogMar score: +1.0) in non-study eye, unless there is an expected benefit for the study eye in the opinion of the investigator.

• Participation in any study involving an investigational drug or device within the past 3 months.

• Only for women of childbearing potential: positive urine pregnancy test at screening.

• Individuals under tutorship or trusteeship.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in medicated mean diurnal IOP at 6 months follow-up compared to medicated diurnal IOP at screening visitTimepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
Absolute and relative reduction (in %) of medicated diurnal IOP compared to medicated <br/ ><br>diurnal IOP at screening visit.Timepoint: Day 1, Week 1, Week 2, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24

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