One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of a Bausch + Lomb One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
1 other identifier
interventional
122
1 country
1
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of the enVista® One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens has been removed by an extracapsular cataract extraction method (eg, small incision phacoemulsification).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 27, 2010
CompletedFirst Posted
Study publicly available on registry
October 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
August 22, 2013
CompletedAugust 22, 2013
August 1, 2013
3 months
October 27, 2010
May 16, 2013
August 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Acuity
Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.
120-180 days (visit 4)
Study Arms (1)
enVista
EXPERIMENTALenVista One-Piece Hydrophobic Acrylic Intraocular Lens
Interventions
One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
Eligibility Criteria
You may qualify if:
- Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
- Subjects must have a best corrected visual acuity (BCVA) equal to or worse than 20/40 in the study eye, with or without a glare source.
- Subjects must have a BCVA projected to be better than 20/30 after IOL implantation in the study eye.
You may not qualify if:
- Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Subjects with any other serious ocular pathology, or underlying serious medical conditions, which based on the Investigator's medical judgment, could confound the results of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb
Aliso Viejo, California, 92656, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jon Hayashida
- Organization
- Bausch & Lomb Incorporated
Study Officials
- STUDY DIRECTOR
Mark Packer, MD,FACS
Drs. Fine, Hoffman & Packer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2010
First Posted
October 28, 2010
Study Start
October 1, 2010
Primary Completion
January 1, 2011
Study Completion
August 1, 2011
Last Updated
August 22, 2013
Results First Posted
August 22, 2013
Record last verified: 2013-08