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A Study of B + L Ophthalmic Viscosurgical Device (OVD) CVisc50 | Clinical Trials | Clareo Health

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

A Study to Document the Safety and Effectiveness of a New Cohesive OVD When Compared to a Control OVD

NCT04192630•Bausch & Lomb Incorporated

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.

Detailed Description

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

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

Locations (22)

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

Key Dates

Start Date

November 26, 2019

Primary Completion Date

January 31, 2022

Completion Date

January 31, 2022

Last Updated

May 28, 2024

Enrollment

390

ACTUAL participants

Conditions

Cataract

Interventions

CVisc50 OVD

DEVICE

ProVisc OVD

DEVICE

Cataract Surgery

PROCEDURE

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

NCT06979752

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

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RECRUITING

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

NCT07362043

Cataract Surgery

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

IC-8 Apthera IOL New Enrollment Post Approval Study

HUD Surgical Guidance for Toric Alignment

PRO-232 in Patients Subjected to Cataract Surgery

Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery