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The purpose of this study is to evaluate the safety and effectiveness of a new opthalmic viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared to a currently marketed viscoelastic material.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitrax II | Experimental | Investigational dispersive viscoelastic |
|
| Viscoat | Active Comparator | Marketed control dispersive viscoelastic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrax II | Device | Viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively | Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months. | 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Mean Endothelial Cell Count | mean endothelial cell count (measured by Konan specular microscope) at 3 months | 3 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMO Clinical Research Call Center for Trial Locations | Santa Ana | California | 92799 | United States |
Enrolled participants who did not meet the inclusion/exclusion criteria as detailed in the protocol were excluded from the trial prior to assignment to study group. Randomization assigned199 Vitrax II subjects and 201 Viscoat subjects, but a randomization error (Viscoat (control) subject treated with Vitrax II) resulted in 200 subjects per group.
Subjects were recruited from the general cataract populations from 11 ophthalmic practices between September 2009 and July 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitrax II | Investigational dispersive viscoelastic |
| FG001 | Viscoat | Currently marketed viscoelastic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Results based on safety population (i.e., the population based on the viscoelastic used). If the randomization scheme had been followed correctly, there would have been 199 Vitrax II subjects and 201 Viscoat subjects, but one subject that should have received Viscoat (control treatment) was treated with Vitrax II, which resulted in 200 per group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitrax II | Investigational dispersive viscoelastic |
| BG001 | Viscoat | Currently marketed viscoelastic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively | Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months. | Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting IOP spikes ≥ 30 mmHg for ITT population, which differs from the safety population used in the Participant Flow. | Posted | Number | 90% Confidence Interval | percentage of participants | 3 months postoperative |
|
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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 | Vitrax II | Investigational dispersive viscoelastic |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IOP Spike greater than or equal to 30 mm HG | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kendra Hileman, Ph.D., Head, Clinical Research & Development | Abbott Medical Optics, Inc. | 714-247-8613 | kendra.hileman@abbott.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Viscoat | Device | Currently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.. |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Viscoat: Control Treatment |
|
|
| Secondary | Postoperative Mean Endothelial Cell Count | mean endothelial cell count (measured by Konan specular microscope) at 3 months | Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting mean endothelial cell count for ITT population, which differs from the safety population used in the Participant Flow. | Posted | Mean | Standard Deviation | number of endothelial cells | 3 months postoperative |
|
|
|
| 0 |
| 200 |
| 21 |
| 200 |
| EG001 | Viscoat | Currently marketed viscoelastic | 0 | 200 | 15 | 200 |
At least ninety (90) days prior to any proposed submission for publication or presentation of Study Data or other findings related to the Study, Institution will provide Sponsor with a manuscript of such submission(s) for review, comment, and approval.