Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.
This study will include only subjects undergoing bilateral, primary, cataract extraction and intraocular lens (IOL) implantation and who meet all of the study inclusion and exclusion criteria in both eyes. Subjects who meet the inclusion/exclusion criteria and agree to participate will be randomly assigned to receive the investigational OVD in one eye and the currently-available (i.e., commercial) OVD in the fellow eye (control). Thus, a single group of subjects will provide data for both the investigational OVD and the control OVD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
241
ophthalmic viscosurgical device
ophthalmic viscosurgical device
Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively
The cumulative rate of IOP spikes with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 10%.
Time frame: 3 months
Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively
The mean percent ECC change with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 5%.
Time frame: 3 months
Ocular Serious Adverse Events (SAE)
Ocular serious and/or device related adverse event rates was be tabulated with the frequency and proportion of eyes with these events reported over time and cumulatively by OVD group. \* in the results table denotes SAEs determined to be device-related
Time frame: 3 months
Mean Change in IOP From Baseline
The mean change in IOP from baseline for both OVD groups over time at the 6 hour, 1 day, 1 week, 1 month, and 3 month postoperative time points are presented.
Time frame: 3 months
Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
The rate of IOP spike 30 mmHg or greater at 6 hour, 1 day, 1 week, 1 month and 3 months postoperatively was tabulated with frequency and proportion by OVD group.
Time frame: 3 months
Grade of Inflammation: Epithelial Edema
The grades of inflammation for epithelial edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
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Time frame: Upto 3 months
Grade of Inflammation: Stromal Edema
The grades of inflammation for stromal edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Time frame: Upto 3 months
Grade of Inflammation: Cells
The grades of inflammation for cells was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Time frame: Upto 3 months
Grade of Inflammation: Flare
The grades of inflammation for flare was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Time frame: Upto 3 months
Grade of Inflammation: Anterior Synechiae
The grades of inflammation for Anterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Time frame: Upto 3 months
Grade of Inflammation: Posterior Synechiae
The grades of inflammation for Posterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Time frame: Upto 3 Months
Grade of Inflammation: Fibrin Presence
The grades of inflammation for Fibrin Presence was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Time frame: Upto 3 Months