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

Completed · Not applicable

Conditions studied: Cataract

In brief

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.

Key facts

Study ID

NCT04192630

Run by

Bausch & Lomb Incorporated

People needed

390

Starts

2019-11-26

Expected to finish

2022-01-31

Last updated by the study team

2024-05-28

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bausch Site 017 — Chandler, Arizona, United States
• Bausch Site 001 — Phoenix, Arizona, United States
• 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
• Bausch Site 020 — Kansas City, Missouri, United States
• Bausch Site 002 — St Louis, Missouri, United States
• Bausch Site 015 — Washington, Missouri, United States
• Bausch Site 005 — New York, New York, United States
• Bausch Site 021 — Mason, Ohio, United States
• Bausch Site 003 — Reading, Pennsylvania, United States
• Bausch Site 014 — Goodlettsville, Tennessee, United States
• Bausch 018 — Nashville, Tennessee, United States
• Bausch Site 009 — Cedar Park, Texas, United States
• Bausch Site 006 — Houston, Texas, United States
• Bausch 022 — San Antonio, Texas, United States
• Bausch Site 016 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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