Back to resultsClinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design
Primary Purpose
Cataract
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BAL-FAIOL IOL
Monofocal IOL
Cataract surgery
Sponsored by
About this trial
This is an interventional device feasibility trial for Cataract focused on measuring IOL, Intraocular lens
Eligibility 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.
Sites / Locations
- Clinica 20/20Recruiting
- Laser Center SARecruiting
- Centro de Retina Medica y Quirurgica SC
- Asociación Para Evitar la Ceguera en México
- Salauno Salud SAPI de CV
- Panama Eye CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BAL-FAIOL
Monofocal
Arm Description
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05317728
Brief Title
Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design
Official Title
Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
IOL, Intraocular lens
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BAL-FAIOL
Arm Type
Experimental
Arm Description
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
Arm Title
Monofocal
Arm Type
Active Comparator
Arm Description
Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)
Intervention Type
Device
Intervention Name(s)
BAL-FAIOL IOL
Intervention Description
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
Intervention Type
Device
Intervention Name(s)
Monofocal IOL
Other Intervention Name(s)
AcrySof IQ monofocal IOL (SN60WF)
Intervention Description
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Phacoemulsification with a clear cornea incision
Primary Outcome Measure Information:
Title
Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)
Description
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).
Time Frame
Month 6 post second eye implantation
Title
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)
Description
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.
Time Frame
Up to Year 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alcon Call Center
Phone
1-888-451-3937
Email
alcon.medinfo@alcon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Surgical
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Clinica 20/20
City
San José
Country
Costa Rica
Individual Site Status
Recruiting
Facility Name
Laser Center SA
City
Santo Domingo
ZIP/Postal Code
10124
Country
Dominican Republic
Individual Site Status
Recruiting
Facility Name
Centro de Retina Medica y Quirurgica SC
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45116
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Asociación Para Evitar la Ceguera en México
City
Mexico City
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Salauno Salud SAPI de CV
City
Mexico City
ZIP/Postal Code
06600
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Panama Eye Center
City
Panama
Country
Panama
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design
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