Active — Not RecruitingNot Applicable

Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design

Costa Rica, Dominican Republic, Mexico175 participantsStarted 2023-03-31

Plain-language summary

The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form; * Willing and able to attend all scheduled study visits as required by the protocol; * Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision; * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Subjects taking medications that may affect accommodation; * Clinically significant eye abnormalities as specified in the protocol; * Previous eye surgery as specified in the protocol; * Other protocol-specified exclusion criteria may apply.

What they're measuring

Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)

Timeframe: Month 6 post second eye implantation

Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)

Timeframe: Up to Year 1

Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) - Cohort 2

Timeframe: Up to Year 1

Trial details

NCT IDNCT05317728

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

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