Feasibility Study of an Accommodating IOL Design

Alcon Research85 enrolled

Overview

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.

This study will enroll adult subjects who require cataract surgery in both eyes. One eye will receive the AAL-FAIOL and the other eye will receive the BAL-FAIOL. The two eye surgeries will be separated by 14-35 days. Subjects will attend follow up visits for approximately 1 year. If needed, the AAL lens may be adjusted after surgery with a laser to help give the participant better vision.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Aphakia

Interventions

AAL-FAIOLDEVICE

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.

BAL-FAIOLDEVICE

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.

PhacoemulsificationPROCEDURE

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

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Locations (5)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

NOT_YET_RECRUITING

Clinica 20/20

San José, Costa Rica

NOT_YET_RECRUITING

Instituto Espaillat Cabral

Santo Domingo, Dominican Republic

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs)

The number of adverse events, including SSI's, will be calculated. An SSI is a subsequent operation performed to address issues or complications arising from a previous surgical procedure. AEs will be collected starting at Day 0 after informed consent. SSIs will be collected starting Day 1.

Time frame: From Day 0 up to Month 12

Central Contacts

Alcon Call Center

CONTACT

1-888-451-3937 alcon.medinfo@alcon.com

Data from ClinicalTrials.gov

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