N/A
N=390
A Study of B + L Ophthalmic Viscosurgical Device (OVD) CVisc50
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT04192630 ↗Enrolled (actual)
390
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit — 10; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CVisc50 OVD (Device); ProVisc OVD (Device); Cataract Surgery (Procedure)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced at Least One Intraocular Pressure (IOP) Measurement ≥30 Millimeters of Mercury (mmHg) at Any Post-Surgical Follow-up Visit |
10; 16 | — |
| PRIMARY Change From Baseline in Corneal Endothelial Cell Density (ECD) in the Study Eye at Postoperative Visit 5 (90 Days ± 14 Days) |
15.7; 15.8 | — |
| SECONDARY Mean Change From Baseline in IOP at the 6-Hour Post-Operative Visit |
19.5; 20.0; 3.8; 4.2 | — |
| SECONDARY Mean Change From Baseline in IOP at the 24-Hour Post-Operative Visit |
18.0; 18.4; 2.3; 2.6 | — |
| SECONDARY 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 |
177; 187; 183; 184 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT04192630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.