Open Angle Glaucoma
Conditions
Keywords
Excimer Laser, Micro-bypass, Trabeculostomy
Brief summary
The primary study objective is to compare the effectiveness of the combination of phacoemulsification with intraocular lens implant with ELIOS or competitor device in reducing IOP at 12 months postoperatively.
Interventions
PROCEDUREELIOS
Following cataract surgery, surgeon will proceed to ELIOS treatment.
PROCEDURECompetitor Device
Following cataract surgery, surgeon will proceed to Competitor treatment.
Sponsors
Elios Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects. 2. 40 years old or older. 3. Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma: 4. Visually significant cataract eligible for phacoemulsification.
Exclusion criteria
1. All forms of angle closure glaucoma 2. Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced, steroid-induced, angle-recession, glaucoma associated with vascular disorders, and glaucoma associated with increased episcleral venous pressure 3. Congenital or developmental glaucoma 4. Prior incisional glaucoma surgery, intraocular surgery or ocular laser treatment of any type with the exception of selective laser trabeculoplasty (SLT) occurring a minimum of 6 months prior to the Screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PRIMARY EFFECTIVENESS ENDPOINTS : IOP | 12 months | Mean change in post-washout diurnal IOP from baseline to 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP | 24 months | Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline. |
| SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications | 12 months | change in number of hypotensive medications from screening to 12 months |
| SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP | 12 months | Mean change in treated IOP from screening to 12 months |
| SECONDARY EFFECTIVENESS ENDPOINTS : Medications | 12 months | Proportion of patients Medication free at 12 months |
Countries
Belgium, France, Germany, Netherlands, Spain, United Kingdom
Contacts
CONTACTCameron Hudson
Outcome results
None listed