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NCT Number: NCT07147192

Feasibility Study of an Accommodating IOL Design

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.

Recruiting

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Key information

Conditions

Aphakia Cataract Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica 20/20, San José, Costa Rica

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AAL-FAIOL

Device

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-FAIOL

Device

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.

phacoemulsification

Procedure

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

Primary outcomes

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

    Time frame: From Day 0 up to Month 12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alcon Call Center

CONTACT

[email protected]

1-888-451-3937

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 29, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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