One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
Study Details
Study Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: enVista enVista One-Piece Hydrophobic Acrylic Intraocular Lens |
Device: enVista
One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity [120-180 days (visit 4)]
Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch & Lomb | Aliso Viejo | California | United States | 92656 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Mark Packer, MD,FACS, Drs. Fine, Hoffman & Packer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 658
Study Results
Participant Flow
| Recruitment Details | This study was conducted at 6 clinical sites in the US. Study started Aug 2010 and was completed June 2011. |
|---|---|
| Pre-assignment Detail | 122 subjects underwent cataract extraction and implantation of the Bausch + Lomb Intraocular Lens (IOL) for the correction of aphakia. |
| Arm/Group Title | enVista |
|---|---|
| Arm/Group Description | enVista One-Piece Hydrophobic Acrylic Intraocular Lens enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery. |
| Period Title: Overall Study | |
| STARTED | 122 |
| COMPLETED | 121 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | enVista |
|---|---|
| Arm/Group Description | enVista One-Piece Hydrophobic Acrylic Intraocular Lens enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery. |
| Overall Participants | 122 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
69.0
(8.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
69
56.6%
|
| Male |
53
43.4%
|
| Region of Enrollment (participants) [Number] | |
| United States |
122
100%
|
Outcome Measures
| Title | Visual Acuity |
|---|---|
| Description | Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation. |
| Time Frame | 120-180 days (visit 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All non missing implanted eyes, consistent set |
| Arm/Group Title | enVista |
|---|---|
| Arm/Group Description | enVista One-Piece Hydrophobic Acrylic Intraocular Lens enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery. |
| Measure Participants | 108 |
| Number [Participants] |
108
88.5%
|
Adverse Events
| Time Frame | 140-180 days | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | enVista | |
| Arm/Group Description | enVista One-Piece Hydrophobic Acrylic Intraocular Lens enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery. | |
All Cause Mortality |
||
| enVista | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| enVista | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/122 (0.8%) | |
| Blood and lymphatic system disorders | ||
| Acute myeloid leukemia | 1/122 (0.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| enVista | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/122 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Jon Hayashida |
|---|---|
| Organization | Bausch & Lomb Incorporated |
| Phone | (949) 521-7876 |
| jon.hayashida@bausch.com |
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