The objective of the study is to evaluate the safety and effectiveness of the Bausch \& Lomb CVisc50 cohesive OVD compared to the Alcon ProVisc® cohesive OVD when used in cataract surgery.
The objective of the study is to evaluate the safety and effectiveness of the Bausch \& Lomb CVisc50 cohesive OVD compared to the Alcon ProVisc® cohesive OVD when used in cataract surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
390
Bausch + Lomb CVisc50 Cohesive OVD
ProVisc OVD
Cataract Surgery
Bausch Site 017
Chandler, Arizona, United States
Bausch Site 001
Phoenix, Arizona, United States
Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit
Time frame: Up to 90 Days ± 14 Days
Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days)
Time frame: Baseline, 90 Days ± 14 Days
Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit
Time frame: Baseline, 6-hour post-operative
Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit
Time frame: Baseline, 24-hour post-operative
Percentage of Participants With Summed Score for Anterior Chamber Cells and Flare Greater Than Zero at the 6-Hour and 24-Hour Post-Operative Visits
Anterior chamber cells were graded on a 6-point scale, with 0 = \<1 cell count; 0.5 = 1 to 5 cell count; 1 = 6 to 15 cell count; 2 = 16 to 25 cell count; 3 = 26 to 50 cell count; and 4 = \>50 cell count. Anterior chamber flare (protein escaping from dilated vessels) was graded on a 5-point scale, with 0 = none; 1 = faint; 2 = moderate; 3 = marked; and 4 = intense.
Time frame: 6-hour and 24-hour post-operative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bausch Site 008
Fayetteville, Arkansas, United States
Bausch Site 010
Burlingame, California, United States
Bausch Site 007
Garden Grove, California, United States
Bausch Site 011
Newport Beach, California, United States
Bausch Site 012
Northridge, California, United States
Bausch Site 013
Rancho Cordova, California, United States
Bausch Site 004
Torrance, California, United States
Bausch Site 019
Bloomington, Minnesota, United States
...and 12 more locations