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

Not Applicable

Completed

• Conditions: Cataract

• Registration Number: NCT04192630
• Lead Sponsor: Bausch & Lomb Incorporated

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.

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.

Study Timeline

• Study Start: 2019-11-26
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-12
• Disposition First Submitted: 2022-12-02
• Results First Submitted: 2023-08-30
• Results First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Results First Posted: 2024-05-28
• Disposition First Posted: 2024-05-28
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit	Baseline, 6-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	Anterior chamber cells were graded on a 6-point scale, with 0 = \<1 cell count; 0.5 = 1 to 5 cell count; 1 = 6 to 15 cell count; 2 = 16 to 25 cell count; 3 = 26 to 50 cell count; and 4 = \>50 cell count. Anterior chamber flare (protein escaping from dilated vessels) was graded on a 5-point scale, with 0 = none; 1 = faint; 2 = moderate; 3 = marked; and 4 = intense.
Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit	Baseline, 24-hour post-operative

Trial Locations

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

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