Aphakia, Cataract
Conditions
Keywords
ocular surgery, phacoemulsification
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).
Interventions
DEVICEenVista
One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
122 subjects underwent cataract extraction and implantation of the Bausch + Lomb Intraocular Lens (IOL) for the correction of aphakia.
Participants by arm
| Arm | Count |
|---|---|
| enVista 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. | 122 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | enVista |
|---|---|
| Age Continuous | 69.0 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 122 participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 122 |
| serious Total, serious adverse events | 1 / 122 |
Outcome results
Primary
Visual Acuity
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)
Population: All non missing implanted eyes, consistent set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| enVista | Visual Acuity | 108 Participants |