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This study is a prospective, randomized, controlled, paired eye, subject-masked design.
Subjects will be randomly assigned to which eye will receive the Omega capsule Gemini IV with an approved monofocal or Toric intraocular lens. Fellow eyes will receive an approved monofocal or Toric IOL (no Omega capsule).
Eyes randomized to receive the Gemini capsule will be eligible to have a secondary procedure (post 1-month postoperative visit) to correct refractive error.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Eye | Experimental | Randomized eyes will receive a Gemini IV device in conjunction with an approved monofocal or toric IOL after cataract extraction |
|
| Control Eye | Active Comparator | control eyes will received an approved monofocal or toric IOL after cataract extraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemini IV | Device | Eyes randomized to receive the Gemini IV device will receive the study device in conjunction with an approved monofocal or toric IOL post cataract extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of fusion of peripheral anterior and posterior capsule to the intraocular lens | Via dilated slit lamp examination subjects will be assessed for anterior and posterior fusion of the IOL to the capsular bag with a dichotomous "Yes/No" response. | 6 month postop 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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 18, 2022 | |
| Reset | Jan 18, 2023 | |
| Release | Jul 29, 2025 | |
| Reset | Aug 14, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 18, 2022 | Jan 18, 2023 | |||
| Jul 29, 2025 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Subjects will be masked to the eye that receives the study device
| Control Eye | Device | Control eyes will receive an approved monofocal or toric IOL post cataract extraction |
|
| Aug 14, 2025 |