Cataract
Conditions
Brief summary
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.
Interventions
DEVICEVitrax II
Viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.
DEVICEViscoat
Currently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Otherwise healthy eye with no pathology other than the presence of cataract * Visual potential of 20/40 or better
Exclusion criteria
* Taking any medications that affect vision, intraocular pressure or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.) * Known intraocular pressure increases from steroid treatment * Low endothelial cell count
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively | 3 months postoperative | Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Mean Endothelial Cell Count | 3 months postoperative | mean endothelial cell count (measured by Konan specular microscope) at 3 months |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the general cataract populations from 11 ophthalmic practices between September 2009 and July 2010.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Vitrax II Investigational dispersive viscoelastic | 200 |
| Viscoat Currently marketed viscoelastic | 200 |
| Total | 400 |
Baseline characteristics
| Characteristic | Viscoat | Vitrax II | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 146 Participants | 133 Participants | 279 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 67 Participants | 121 Participants |
| Age, Continuous | 70.1 years STANDARD_DEVIATION 8.86 | 68.0 years STANDARD_DEVIATION 8.88 | 69.03 years STANDARD_DEVIATION 8.92 |
| Region of Enrollment United States | 200 participants | 200 participants | 400 participants |
| Sex: Female, Male Female | 120 Participants | 127 Participants | 247 Participants |
| Sex: Female, Male Male | 80 Participants | 73 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 200 | 15 / 200 |
| serious Total, serious adverse events | 0 / 200 | 0 / 200 |
Outcome results
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.
Time frame: 3 months postoperative
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitrax II | Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively | 10.6 percentage of participants |
| Viscoat | Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively | 7.6 percentage of participants |
Secondary
Postoperative Mean Endothelial Cell Count
mean endothelial cell count (measured by Konan specular microscope) at 3 months
Time frame: 3 months postoperative
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitrax II | Postoperative Mean Endothelial Cell Count | 2454.3 number of endothelial cells | Standard Deviation 28.87 |
| Viscoat | Postoperative Mean Endothelial Cell Count | 2366.3 number of endothelial cells | Standard Deviation 33.29 |