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The objective of this study is to evaluate the safety and effectiveness of the
investigational Omega Refractive Capsule (model V)
This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design.
Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule V with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Eye | Experimental | Omega Refractive capsule, model V, with an FDA approved intraocular lens. |
|
| Control Eye | Active Comparator | FDA approved Intraocular Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega Refractive Capsule with FDA approved Intraocular Lens | Device | Omega Refractive Capsule with FDA approved Intraocular Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of fusion of peripheral anterior and posterior capsule | slit lamp exam | 6 Month Postoperative Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Orlich, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica 20/20 | San José | Costa Rica |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design.
Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule V with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).
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subjects will be masked to treatment
| FDA approved Intraocular lens | Device | FDA approved Intraocular lens |
|