A Study of B + L Ophthalmic Viscosurgical Device (OVD) CVisc50
NCT ID: NCT04192630
Last Updated: 2024-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
390 participants
INTERVENTIONAL
2019-11-26
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CVisc50 Ophthalmic Viscosurgical Device (OVD)
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.
CVisc50 OVD
Bausch + Lomb CVisc50 Cohesive OVD
Cataract Surgery
Cataract Surgery
ProVisc OVD
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.
ProVisc OVD
ProVisc OVD
Cataract Surgery
Cataract Surgery
Interventions
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CVisc50 OVD
Bausch + Lomb CVisc50 Cohesive OVD
ProVisc OVD
ProVisc OVD
Cataract Surgery
Cataract Surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
45 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Anya Loncaric
Role: STUDY_DIRECTOR
B+L
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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878
Identifier Type: -
Identifier Source: org_study_id
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