Cataract
Conditions
Keywords
IOL, Intraocular lens
Brief summary
The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).
Detailed description
In this study, eligible subjects will receive cataract surgery with IOL implantation in both eyes. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation. This study will enroll 2 cohorts. Cohort 1 subjects will be randomized to receive either the test IOL (BAL-FAIOL) or the control IOL (Monofocal). Cohort 2 subjects will receive the test IOL only (BAL-FAIOL). Cohort 2 will follow Cohort 1. This study will be conducted in Central America.
Interventions
DEVICEBAL-FAIOL IOL
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
DEVICEMonofocal IOL
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
PROCEDURECataract surgery
Phacoemulsification with a clear cornea incision
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Cohort 1 is a subject and assessor-masked comparison. Cohort 2 does not utilize masking.
Intervention model description
Cohort 1 utilizes a parallel-group study design. Cohort 2 utilizes a single-group study design.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form; * Willing and able to attend all scheduled study visits as required by the protocol; * Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision; * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Subjects taking medications that may affect accommodation; * Clinically significant eye abnormalities as specified in the protocol; * Previous eye surgery as specified in the protocol; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) | Month 6 post second eye implantation | Distance visual acuity will be measured with correction in place for each eye individually using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR). This outcome measure is pre-specified for Cohort 1 and Cohort 2. |
| Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) | Up to Year 1 | The number of adverse events, including SSI's, will be calculated from time of implantation. This outcome measure is pre-specified for Cohort 1 BAL-FAIOL IOL only. |
| Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) - Cohort 2 | Up to Year 1 | The number of adverse events, including SSI's, will be calculated from time of implantation. The outcome measure is pre-specified for Cohort 2 only |
Countries
Costa Rica, Dominican Republic, Mexico, Panama
Contacts
STUDY_DIRECTORClinical Trial Lead, Surgical
Alcon Research, LLC
Outcome results
None listed