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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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This study aims to identify if the use of BSS PLUS® Sterile Intraocular Irrigating Solution as an irrigation solution leads to improved corneal outcomes vs BSS® Sterile Irrigating Solution in more compromised corneas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSS Plus | Experimental |
| |
| BSS | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BSS Plus | Drug | BSS PLUS® Sterile Intraocular Irrigating Solution (balanced salt solution enriched with bicarbonate, dextrose, and glutathione) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Corneal Thickness (CCT) | Changes in central corneal thickness following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution | Postoperative: Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Grading of Corneal Edema | Intraoperative grading of corneal edema during cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution. | Day 0 |
| Number of Intraocular Irrigating Solution Drops Used |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Surface Keratopathy and Conjunctival Staining | Changes in corneal surface keratopathy and conjunctival staining following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution. | Postoperative: Day 1 and Week 1 |
| Conjunctival Injection |
Inclusion Criteria
Adults, 22 years of age or older, with bilateral visually significant cataracts.
Subjects with Fuch's Dystrophy that present with:
Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension
Ability to comprehend and sign a statement of informed consent.
Ability to complete all required postoperative visits.
Willingness to use at least one medically acceptable form of birth control throughout the duration of study participation. (for female subjects of childbearing potential only).
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis Eye Institute | Town and Country | Missouri | 63017 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2026 | May 15, 2026 | 4 |
| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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| ID | Term |
|---|---|
| C013003 | glutathione-bicarbonate-Ringer solution |
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| BSS | Drug | BSS® Sterile Irrigating Solution (balanced salt solution) |
|
Number of BSS PLUS® Sterile Intraocular Irrigating Solution drops used during cataract surgery to rewet corneal surface and maintain clarity, as compared to BSS® Sterile Irrigating Solution. |
| Day 0 |
Changes in conjunctival injection following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution. |
| Postoperative: Day 1 and Week 1 |
| Ocular Comfort Index (OCI) | Assessment of Ocular Comfort Index (OCI) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution. | Postoperative: Day 1 and Week 1 |
| Best Corrected Visual Acuity (BCVA) | Best Corrected Visual Acuity (BCVA) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution. | Postoperative: Month 1 |
| Endothelial Cell Density (ECD) | Endothelial Cell Density (ECD) following cataract surgery with BSS PLUS® Sterile Intraocular Irrigating Solution, as compared to BSS® Sterile Irrigating Solution. | Postoperative: Month 1 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007905 | Lens Diseases |