N/A
N=372
Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40)
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT03511638 ↗Enrolled (actual)
372
Serious AEs
1.3%
Results posted
Oct 2021
Primary outcome: Primary: Percent Change in Mean Epithelial Cell Density (ECD) — -8.4; -6.8 percentage change in ECD
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bausch & Lomb DVisc40 (Device); Alcon VISCOAT® (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Mean Epithelial Cell Density (ECD) |
-8.4; -6.8 | — |
| PRIMARY Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg |
17.4; 20.3 | — |
Summary
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
Eligibility Criteria
Inclusion Criteria
- The subject 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 subject 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 subject must be willing and able to return for all scheduled follow-up examinations through 90 days following surgery.
Study #877 Protocol DVisc40 28JUL2017 V1.0 CONFIDENTIAL Page 16 of 53 4. The subject must have clear intraocular media other than the cataract in the operative eye.
Exclusion Criteria
- 1. The subject has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
- The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.
- The subject has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye.
- The subject has any condition which prevents reliable specular microscopy in the operative eye.
Data sourced from ClinicalTrials.gov (NCT03511638). 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.