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

NCT04192630 | Completed Results FDA Device

• 1 other identifier: 878
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit

  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)

  Baseline, 90 Days ± 14 Days

Secondary Outcomes (3)

• Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit

  Baseline, 6-hour post-operative

• Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit

  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

  6-hour and 24-hour post-operative

Study Arms (2)

CVisc50 Ophthalmic Viscosurgical Device (OVD)

EXPERIMENTAL

CVisc50 OVD will be carefully injected into the anterior chamber using standard aseptic technique, during the surgical procedure. The duration of the treatment is anticipated to be approximately 15-20 minutes for the surgical procedure. The OVD may also be used to coat surgical instruments prior to Intraocular Lens (IOL) implantation (for example, the internal surfaces of an IOL inserter are typically filled and/or coated with the OVD to provide lubricity during IOL compression and delivery into the eye). Additional OVD of the same product, may be injected as needed throughout surgery to keep the anterior chamber fully formed and to re-inflate the capsular bag following cataract removal. At the end of the surgical procedure it is recommended that OVD be removed from the eye as completely as practical by thoroughly irrigating and aspirating with a sterile irrigating solution.

Device: CVisc50 OVD; Procedure: Cataract Surgery

ProVisc OVD

ACTIVE COMPARATOR

ProVisc OVD will be carefully injected into the anterior chamber using standard aseptic technique, during the surgical procedure. The duration of the treatment is anticipated to be approximately 15-20 minutes for the surgical procedure. The OVD may also be used to coat surgical instruments prior to IOL implantation (for example, the internal surfaces of an IOL inserter are typically filled and/or coated with the OVD to provide lubricity during IOL compression and delivery into the eye). Additional OVD of the same product, may be injected as needed throughout surgery to keep the anterior chamber fully formed and to re-inflate the capsular bag following cataract removal. At the end of the surgical procedure it is recommended that OVD be removed from the eye as completely as practical by thoroughly irrigating and aspirating with a sterile irrigating solution.

Device: ProVisc OVD; Procedure: Cataract Surgery

Interventions

CVisc50 OVD DEVICE

Bausch + Lomb CVisc50 Cohesive OVD

Also known as: Bausch + Lomb CVisc50 Cohesive OVD

CVisc50 Ophthalmic Viscosurgical Device (OVD)

ProVisc OVD DEVICE

ProVisc OVD

Also known as: Alcon ProVisc® OVD

ProVisc OVD

Cataract Surgery PROCEDURE

Cataract Surgery

CVisc50 Ophthalmic Viscosurgical Device (OVD); ProVisc OVD

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (22)

Bausch Site 017

Chandler, Arizona, 85224, United States

Location

Bausch Site 001

Phoenix, Arizona, 85032, United States

Location

Bausch Site 008

Fayetteville, Arkansas, 72704, United States

Location

Bausch Site 010

Burlingame, California, 94010, United States

Location

Bausch Site 007

Garden Grove, California, 92843, United States

Location

Bausch Site 011

Newport Beach, California, 92662, United States

Location

Bausch Site 012

Northridge, California, 91325, United States

Location

Bausch Site 013

Rancho Cordova, California, 95670, United States

Location

Bausch Site 004

Torrance, California, 90505, United States

Location

Bausch Site 019

Bloomington, Minnesota, 55420, United States

Location

Bausch Site 020

Kansas City, Missouri, 64154, United States

Location

Bausch Site 002

St Louis, Missouri, 63131, United States

Location

Bausch Site 015

Washington, Missouri, 63090, United States

Location

Bausch Site 005

New York, New York, 10013, United States

Location

Bausch Site 021

Mason, Ohio, 45040, United States

Location

Bausch Site 003

Reading, Pennsylvania, 96002, United States

Location

Bausch Site 014

Goodlettsville, Tennessee, 37073, United States

Location

Bausch 018

Nashville, Tennessee, 37215, United States

Location

Bausch Site 009

Cedar Park, Texas, 78613, United States

Location

Bausch Site 006

Houston, Texas, 77008, United States

Location

Bausch 022

San Antonio, Texas, 78215, United States

Location

Bausch Site 016

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Packer M, Shultz M, Loden J, Lau G. Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device. J Cataract Refract Surg. 2023 Aug 1;49(8):804-811. doi: 10.1097/j.jcrs.0000000000001201.

  PMID: 37079390 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Anya Loncaric, Executive Director, Global Clinical Operations
• Organization: Bausch + Lomb Incorporated

Anya.Loncaric@bauschcloud.com

(310) 770-7750

Study Officials

• Anya Loncaric

  B+L

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: November 26, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: May 28, 2024
• Results First Posted: May 28, 2024

Record last verified: 2022-12

Locations

US (22)