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

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Alcon

Status

Enrolling

Conditions

Cataract

Treatments

Procedure: Cataract surgery
Device: BAL-FAIOL IOL
Device: Monofocal IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT05317728
ILR286-E002

Details and patient eligibility

About

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

Full description

Eligible subjects will be enrolled into one of two groups: BAL-FAIOL IOL or Monofocal IOL. Both eyes will receive cataract surgery with IOL implantation. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation.

Enrollment

120 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 could increase risk or 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.

Trial design

Primary purpose

Device Feasibility

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

BAL-FAIOL
Experimental group
Description:
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
Treatment:
Device: BAL-FAIOL IOL
Procedure: Cataract surgery
Monofocal
Active Comparator group
Description:
Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)
Treatment:
Device: Monofocal IOL
Procedure: Cataract surgery

Trial contacts and locations

6

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Central trial contact

Alcon Call Center

Data sourced from clinicaltrials.gov

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