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

Cataract Clinical Trial

Official title:

Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317728
• Other study ID #: ILR286-E002
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• BAL-FAIOL IOL
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
• Monofocal IOL
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject

Procedure:
• Cataract surgery
Phacoemulsification with a clear cornea incision

Locations

Country	Name	City	State
Costa Rica	Clinica 20/20	San José
Dominican Republic	Laser Center SA	Santo Domingo
Mexico	Asociación Para Evitar la Ceguera en México	Mexico City
Mexico	Salauno Salud SAPI de CV	Mexico City
Mexico	Centro de Retina Medica y Quirurgica SC	Zapopan	Jalisco
Panama	Panama Eye Center	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Countries where clinical trial is conducted

Costa Rica,  Dominican Republic,  Mexico,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)	Distance visual acuity will be measured with correction in place for each eye individually using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).	Month 6 post second eye implantation
Primary	Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)	The number of adverse events, including SSI's, will be calculated from time of implantation. This outcome measure is pre-specified for the BAL-FAIOL IOL only.	Up to Year 1