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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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The purpose of this multicenter, prospective, randomized clinical study is to determine the safety and effectiveness of the EYEFILL® C.-US Viscoelastic in patients undergoing cataract extraction and intraocular lens (IOL) implantation surgery.
EYEFILL® C.-US Viscoelastic is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues, and to manipulate tissues during surgery.
EYEFILL® C.-US Viscoelastic may also be used to coat intraocular lenses and instruments during cataract extraction and intraocular lens insertion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EYEFILL® C.-US Viscoelastic | Experimental | EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. |
|
| Healon® Viscoelastic (CONTROL) | Active Comparator | Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EYEFILL® C.-US Viscoelastic | Device | EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Cell Change (Preservation of Endothelium) | Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit | 3 months | |
| Percentage of Participants With Anterior Chamber Inflammation | 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald R Sanders, MD, PhD | Center for Clinical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Phoenix | Arizona | 85016 | United States | ||
| Shasta Eye Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | EYEFILL® C.-US Viscoelastic | EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. EYEFILL® C.-US Viscoelastic: EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. |
| FG001 | Healon® Viscoelastic (CONTROL) | Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. Healon® Viscoelastic (CONTROL): Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EYEFILL® C.-US Viscoelastic | EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. EYEFILL® C.-US Viscoelastic: EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Cell Change (Preservation of Endothelium) | Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density. | Participants with endothelial cell density recorded at baseline and 3 months are included in the population. | Posted | Mean | Standard Deviation | percent cell change | Baseline, 3 months |
|
3 months
Adverse events were not coded. Therefore, source vocabulary is not applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EYEFILL® C.-US Viscoelastic | EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. EYEFILL® C.-US Viscoelastic: EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Total colon blockage | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal stromal edema | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001035 | Aphakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| Healon® Viscoelastic (CONTROL) | Device | Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. |
|
| Percentage of Participants With Device-related Adverse Events Any Visit |
| 3 months |
| Redding |
| California |
| 96002 |
| United States |
| Argus Research at Cape Coral Eye Center | Cape Coral | Florida | 33904 | United States |
| Eye Centers of Florida | Fort Myers | Florida | 33901 | United States |
| Newsom Eye and Laser Center | Sebring | Florida | 33870 | United States |
| Great Lakes Eye Care | Saint Joseph | Michigan | 49085 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| Comprehensive Eye Care | Washington | Missouri | 63090 | United States |
| BG001 | Healon® Viscoelastic (CONTROL) | Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. Healon® Viscoelastic (CONTROL): Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Healon® Viscoelastic (CONTROL) | Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. Healon® Viscoelastic (CONTROL): Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. |
|
|
| Secondary | Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Percentage of Participants With Anterior Chamber Inflammation | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Percentage of Participants With Device-related Adverse Events Any Visit | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 1 |
| 130 |
| 69 |
| 130 |
| EG001 | Healon® Viscoelastic (CONTROL) | Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. Healon® Viscoelastic (CONTROL): Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. | 2 | 132 | 72 | 132 |
| Death due to undiagnosed cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Blood clot | Vascular disorders | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Posterior capsular opacity | Eye disorders | Non-systematic Assessment |
|
| Macular degeration | Eye disorders | Non-systematic Assessment |
|
Contact sponsor directly for details.
| Day 30 |
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| Day 90 |
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