Overview
The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).
Description
Eligible subjects will be enrolled into one of two groups: BAL-FAIOL IOL or Monofocal IOL. Both eyes will receive cataract surgery with IOL implantation. 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.
Eligibility
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 could increase risk or may affect accommodation;
- Clinically significant eye abnormalities as specified in the protocol;
- Previous eye surgery as specified in the protocol;
- Other protocol-specified exclusion criteria may apply.
