RecruitingNot ApplicableNCT07147192

Feasibility Study of an Accommodating IOL Design


Sponsor

Alcon Research

Enrollment

85 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 22 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria4

  • 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.

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Interventions

DEVICEAAL-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.

DEVICEBAL-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.

PROCEDUREPhacoemulsification

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

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NCT07147192


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