Glaucoma
Conditions
Keywords
glaucoma, drainage device, filtering surgery
Brief summary
A new self-adjustable glaucoma drainage device has been developed. And to test its efficacy and its safety, a pilot study is designed.
Interventions
DEVICEeyeValve
Implantation of a self adjustable glaucoma drainage device
Sponsors
Rheon Medical SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged 18 to 90 years. Diagnosis of primary open-angle glaucoma meeting the following criteria: * Intraocular pressure (IOP) not controlled by at least one (1) or more classes of topical IOP-lowering medications, and * Eye without visual acuity. Patients must be able to understand the study requirements and provide written informed consent. Patients must be willing to follow study instructions, agree to comply with all study procedures, and be able to attend all scheduled follow-up visits for at least 6 months after surgery.
Exclusion criteria
* Previous filtering surgery, secondary glaucoma, severe systemic disease, pregnancy, breastfeeding, or inability to understand or provide informed consent. Pregnant or breastfeeding women, or women of childbearing potential who are not willing to use a medically acceptable method of contraception from the screening visit until the 12-month follow-up visit. Known or suspected allergy or hypersensitivity to any component of the device (e.g., silicone). Current participation, or participation within the last 30 days (from the screening visit), in another investigational drug or interventional device clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 3 months | Type and rate of complications post-surgery |
| IOP reduction | Baseline versus every visit, up to 1 year | IOP reduction by \>20% |
Countries
Senegal
Outcome results
None listed