Open Angle Glaucoma
Conditions
Keywords
glaucoma, glaucoma drainage device, glaucoma shunt
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.
Interventions
DEVICESTARflo Glaucoma Implant
Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.
Sponsors
iSTAR Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Diagnosis of refractory open angle glaucoma * Documented 21 mmHg \< IOP ≤ 40 mmHg, under medication * Patient must provide written informed consent Main
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP | 12 months | IOP of each patients at baseline will be compared to IOP of patient after 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in number of IOP lowering medications at 12 months vs. baseline | 12 months | compare number of active ingredient of each patients at baseline vs number of active ingredient after 12 months |
| Reduction in number of IOP lowering medications at 24 months vs. baseline | 24 months | compare number of active ingredient of each patients at baseline vs number of active ingredient after 24 months |
| Rate of adverse events | 24 months | assessment and counting of adverse events (% by adverse event) including procedure related complications |
| Visual Acuity | 12 months | comparison of visual acuity at 12 months vs. baseline |
| Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP | 24 months | IOP of each patients at baseline will be compared to IOP of patient after 24 months |
| Qualified success rate (%) at 12 months | 12 months | qualified success: IOP \< 21mmHg and \< 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication |
| Qualified success rate (%) at 24 months | 24 months | qualified success: IOP \< 21mmHg and \< 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication |
| Absolute success rate (%) at 24 months | 24 months | absolute success: IOP \< 21mmHg and \< 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication |
| Absolute success rate (%) at 12 months | 12 months | absolute success: IOP \< 21mmHg and \< 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication |
Countries
Belgium, Bulgaria, France, Germany, Switzerland
Outcome results
None listed