A Prospective, Non-comparative, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the STARflo Glaucoma Implant in Patients With Open Angle Glaucoma
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Open Angle Glaucoma
- Sponsor
- iSTAR Medical
- Enrollment
- 42
- Locations
- 8
- Primary Endpoint
- Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.
Detailed Description
This is a prospective, multicenter clinical trial to assess the efficacy and the safety of the STARflo™ Glaucoma Implant. Patients will enter the study after providing written informed consent. Patients will be screened to confirm that they are eligible for study participation. When eligibility has been established using the in/exclusion criteria, surgery will be scheduled. Pre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of refractory open angle glaucoma
- •Documented 21 mmHg \< IOP ≤ 40 mmHg, under medication
- •Patient must provide written informed consent
Exclusion Criteria
- •Patients with diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye
- •Patients who failed one or more cilio ablative procedure in the study eye if these cilio ablative procedures were performed as a consequence of previous failed filtering surgery
- •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
Outcomes
Primary Outcomes
Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP
Time Frame: 12 months
IOP of each patients at baseline will be compared to IOP of patient after 12 months
Secondary Outcomes
- Visual Acuity(12 months)
- Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP(24 months)
- Reduction in number of IOP lowering medications at 12 months vs. baseline(12 months)
- Reduction in number of IOP lowering medications at 24 months vs. baseline(24 months)
- Rate of adverse events(24 months)
- Absolute success rate (%) at 12 months(12 months)
- Qualified success rate (%) at 12 months(12 months)
- Qualified success rate (%) at 24 months(24 months)
- Absolute success rate (%) at 24 months(24 months)