RECRUITINGINTERVENTIONAL

Feasibility Study of an Accommodating IOL Design

About This Trial

The purpose of this clinical study is to assess safety and explore usability and effectiveness of the test product, AAL-FAIOL. This study will be conducted in Central America.

Who May Be Eligible (Plain English)

Key Who May Qualify: - Able to understand and sign an willing to sign a consent form Form. - Willing and able to attend all scheduled study visits required per protocol. - Diagnosed with bilateral cataracts requiring removal by phacoemulsification. - Preoperative corneal astigmatism equal to or less than 1.50 diopter (D) in both eyes. - Other protocol-defined inclusion criteria may apply. Key Who Should NOT Join This Trial: - Women of childbearing potential who are pregnant, intend to become pregnant during the study, or are breastfeeding. - Taking medications that could increase risk or may affect accommodation. - Eye conditions as specified in the protocol, including glaucoma or ocular hypertension. - Medical conditions that could increase operative risk as specified in the protocol. - Other protocol-defined exclusion criteria may apply. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Key Inclusion Criteria: * Able to understand and sign an Informed Consent Form. * Willing and able to attend all scheduled study visits required per protocol. * Diagnosed with bilateral cataracts requiring removal by phacoemulsification. * Preoperative corneal astigmatism equal to or less than 1.50 diopter (D) in both eyes. * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Women of childbearing potential who are pregnant, intend to become pregnant during the study, or are breastfeeding. * Taking medications that could increase risk or may affect accommodation. * Eye conditions as specified in the protocol, including glaucoma or ocular hypertension. * Medical conditions that could increase operative risk as specified in the protocol. * Other protocol-defined exclusion criteria may apply.

Treatments Being Tested

DEVICE

AAL-FAIOL

Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject. Laser energy to specified locations can be used to allow a change in power for far distances.

DEVICE

BAL-FAIOL

Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.

PROCEDURE

Phacoemulsification

Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.

Locations (5)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Clinica 20/20

San José, Costa Rica

Instituto Espaillat Cabral

Santo Domingo, Dominican Republic

Centro Panamericano de Ojos / Clinica Lopez Beltran

San Salvador, El Salvador

Panama Eye Center

Panama City, Panama