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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Contralateral implantation
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AAL-FAIOL 		The clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye.
  • 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.
  • Procedure: Phacoemulsification
    Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
Experimental
BAL-FAIOL 		The clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye.
  • 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.

More Details

Status
Recruiting
Sponsor
Alcon Research

Study Contact

Alcon Call Center
1-888-451-3937
alcon.medinfo@alcon.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.