a study of b + l ophthalmic viscosurgical device (ovd) cvisc50

Conditions: Cataract

Summary: 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.

Eligibility criteria:
inclusion criteria: * the participant must be at least 45 years old and have a clinically documented diagnosis of age-related non-complicated cataract that is considered amenable to treatment with standard phacoemulsification cataract extraction and iol implantation. * the participant must have the capability to provide written informed consent on the institutional review board (irb)/ethics committee (ec) approved informed consent form (icf) and provide authorization as appropriate for local privacy regulations. * the participant must be willing and able to undergo all pre-surgical and surgical procedures and to return for all scheduled follow-up examinations through 90 days following surgery. * the participant must have clear intraocular media other than the cataract in the operative eye. exclusion criteria: * the participant has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or plans to do so during the period of study participation. * the participant has any corneal pathology (for example; significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye. * the participant has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (for example; pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye. * the participant has any condition which prevents reliable specular microscopy in the operative eye. * the participant has a congenital ocular anomaly (for example; aniridia, congenital cataract) in the operative eye. * the participant has a baseline ecd \<1500 cells/square millimeter (mm\^2) in the operative eye. * the participant has a grade 4+ nuclear cataract density in the planned operative eye. * the participant has glaucoma or ocular hypertension (iop \>24 mmhg) in the operative eye. * the participant has any abnormality which prevents reliable goldmann applanation tonometry in the operative eye. * the participant has a known allergy to any of the components of the test or control ovds. * the participant is using any topical or systemic medications known to interfere with visual performance or complicate cataract surgery within 30 days of enrollment or during the study. * the participant is scheduled to undergo other combined intraocular procedures during the cataract/intraocular lens (iol) implantation surgery in the operative eye. note: a relaxing keratotomy is allowed. * the participant has diabetic retinopathy, wet age-related macular degeneration or other retinal pathology which might limit postoperative visual acuity (va) or predispose the participant to postoperative retinal complications in the operative eye. * the participant's fellow eye is already participating in this study. * the participant has a history of chronic or recurrent inflammatory eye disease (for example; iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye. * the participant has a best corrected distance visual acuity (bcdva) of logarithm of minimum angle resolution (logmar) 1.0 (20/200, 6/60) or worse in the fellow eye. * the participant has had previous corneal surgery in the planned operative eye. * the participant has a previous retinal detachment in the operative eye. * females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) are excluded from participation in the study if they are currently pregnant; plan to become pregnant during the study; and/or are breast-feeding.