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To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus for use during cataract surgery in Pediatric patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGOIS | Experimental |
| |
| BSS Plus | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next Generation Ophthalmic Irrigating Solution (NGOIS) | Drug | Volume sufficient to irrigate adequately during cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Lane | Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon for Trial Locations | Fort Worth | Texas | 76134 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C013003 | glutathione-bicarbonate-Ringer solution |
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| BSS Plus | Drug | Volume sufficient to irrigate adequately during cataract surgery |
|