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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | ELIOS |
|
| Arm 2 | Active Comparator | Competitor Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELIOS | Procedure | Following cataract surgery, surgeon will proceed to ELIOS treatment. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PRIMARY EFFECTIVENESS ENDPOINTS : IOP | Mean change in post-washout diurnal IOP from baseline to 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP | Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline. | 24 months |
| SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications |
| Measure | Description | Time Frame |
|---|---|---|
| SAFETY ENDPOINTS : adverse events | Rates of ocular adverse events | 24 months |
| Safety endpoints: Retinal nerve fiber layer thickness | measurement of Retinal nerve fiber layer thickness |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cameron Hudson | Contact | +33388308811 | Cameron.Hudson@bausch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ELIOS Clinical Site | Recruiting | Leuven | Belgium |
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| Competitor Device |
| Procedure |
Following cataract surgery, surgeon will proceed to Competitor treatment. |
|
change in number of hypotensive medications from screening to 12 months
| 12 months |
| SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP | Mean change in treated IOP from screening to 12 months | 12 months |
| SECONDARY EFFECTIVENESS ENDPOINTS : Medications | Proportion of patients Medication free at 12 months | 12 months |
| 12 months (with a planned extension of analysis at 24 months) |
| Elios Clinical Site | Recruiting | Avranches | France |
|
| ELIOS Clinical Site | Recruiting | Bordeaux | France |
|
| ELIOS clinical site | Recruiting | Paris | France |
|
| ELIOS Clinical Site | Recruiting | Bochum | Germany |
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| Elios clinical site | Recruiting | Bonn | Germany |
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| ELIOS clinical site | Recruiting | Heidelberg | Germany |
|
| ELIOS Clinical Site | Recruiting | Maastricht | Netherlands |
|
| ELIOS clinical site | Recruiting | Barcelona | Spain |
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| ELIOS Clincal Site | Recruiting | Madrid | Spain |
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| ELIOS Clinical site | Recruiting | Madrid | Spain |
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| ELIOS Clinical Site | Recruiting | East Grinstead | United Kingdom |
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| ELIOS Clinical Site | Recruiting | Edinburgh | United Kingdom |
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| ELIOS Clinical Site | Recruiting | Guildford | United Kingdom |
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| ELIOS clinical site | Recruiting | London | United Kingdom |
|
| ELIOS Clinical Site | Recruiting | Manchester | United Kingdom |
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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