A Study of B + L Ophthalmic Viscosurgical Device (OVD) CVisc50

Launched by BAUSCH & LOMB INCORPORATED · Dec 6, 2019

Keywords

ClinConnect 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.

Gender

ALL

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.