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The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DisCoVisc® | Experimental | DisCoVisc® Ophthalmic Viscosurgical Device |
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| Healon | Active Comparator | Healon |
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| Amvisc Plus | Active Comparator | Amvisc Plus |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DisCoVisc® | Device | Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Cell Count Change From Baseline | Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium. | one month |
| Investigator Reported Space Maintenance | Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion. | During surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Corneal Thickness | Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry. | 1 month |
| Corneal Clarity | Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center | Fort Worth | Texas | 76134 | United States |
Patients were screened prior to cataract operation
Patients were undergoing a cataract operation and were recruited from surgery during 2008 to 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | DisCoVisc® | DisCoVisc® Ophthalmic Viscosurgical Device |
| FG001 | Healon | Healon |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Healon | Drug | Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure |
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| Amvisc Plus | Drug | Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure |
|
| 2 weeks |
| FG002 |
| Amvisc Plus |
Amvisc Plus |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DisCoVisc® | DisCoVisc® Ophthalmic Viscosurgical Device |
| BG001 | Healon | Healon |
| BG002 | Amvisc Plus | Amvisc Plus |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Endothelial Cell Count Change From Baseline | Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium. | Only those participants that had endothelial cell counts at both baseline and follow-up were included in this analysis. | Posted | Mean | Standard Deviation | Percent change from baseline | one month |
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| Primary | Investigator Reported Space Maintenance | Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion. | Posted | Number | participants | During surgical procedure |
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| Secondary | Change in Corneal Thickness | Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry. | Subjects that did not have both baseline and 1 month values were not included in this analysis. | Posted | Median | Standard Deviation | millimeters | 1 month |
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| ||||||||||||||||||||||||||||||||
| Secondary | Corneal Clarity | Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen. | Data from subjects for whom this evaluation was not performed is not included in this analysis. | Posted | Number | units on a scale | 2 weeks |
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1 month
All adverse events were recorded by Principal Investigator.
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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 | DisCoVisc® | DisCoVisc® Ophthalmic Viscosurgical Device | 0 | 61 | 0 | 61 | ||
| EG001 | Healon | Healon | 0 | 60 | 0 | 60 | ||
| EG002 | Amvisc Plus | Amvisc Plus | 0 | 63 | 0 | 63 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Male |
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