Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

The purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating IOL (FAIOL).

Study Overview

• Status: Completed
• Conditions: Presbyopia; Aphakia
• Intervention / Treatment: Device: Alcon Fluid Accommodating Intraocular Lens; Other: Top Con Autorefractor

Detailed Description

Subjects will be expected to attend 10 office visits from screening to exit. The total expected duration of participation for each subject in this study is approximately 12 months. The second eye surgery will take place within 7-15 days from the date of the first implanted eye. The primary endpoint will be collected at Month 1, following the 2nd eye implant date.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• El Salvador
  • San Salvador, El Salvador, 4625
    • Alcon Investigator 8071
• Panama
  • Panamá, Panama
    • Alcon Investigator 8165

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Willing and able to attend all scheduled study visits as required per protocol
• 22 years of age or older
• Bilateral cataracts
• Corneal astigmatism ≤ 1.25 D
• Clear intraocular media other than cataract
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:

  1. are currently pregnant,
  2. have a positive urine pregnancy test result at V0,
  3. intend to become pregnant during the study period,
  4. are breast-feeding.
• Subjects taking medications that may affect accommodation, confound the outcome, or as per the Investigator's opinion may increase the risk to the subject
• Glaucoma
• Significant corneal or retinal abnormalities, per the Investigator's opinion, or other disease or pathology other than cataract expected to reduce postoperative vision
• Monocular patient, significant permanent visual function loss, or binocular vision anomalies as evaluated by specific testing
• Previous corneal procedure (such as LASIK, keratotomy, LRI) or plans to have additional corneal procedures during the study
• Systemic disease that could increase the operative risk or confound the outcome
• Other protocol-specified exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAIOL; Implantation of FAIOL in the capsular bag in the posterior chamber of the eye. The IOL is intended to be used over the lifetime of the subject.	Device: Alcon Fluid Accommodating Intraocular Lens; Intraocular lens intended to treat presbyopia by dynamically adjusting power, resulting in a continuous range of vision from distance to near.; Other Names: FAIOL; FluidVision MX Accommodating IOL; Other: Top Con Autorefractor; Device intended to automatically determine the focusing characteristics of the eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability of objective refraction	Two assessments of objective refraction (sphere, cylinder, and spherical equivalent) using auto refraction will be made on the same day. Repeatability of objective refraction will be evaluated using the Intra-class correlation coefficient (ICC), separately by eye. ICC is evaluated as the proportion of all variation that is not due to measurement error. Higher values of ICC indicate lower error variance and hence better repeatability. Repeatability of objective refraction will be assessed with and without cycloplegia (temporary paralysis of the ciliary muscle).	Month 1 (post 2nd eye implant)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Operation Lead CDMA Surgical, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Actual): June 8, 2022
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Cataract; IOL; Accommodation
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Presbyopia; Aphakia
• Other Study ID Numbers: ILR286-E003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes