NCT04330001

Brief Summary

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

December 28, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

March 30, 2020

Last Update Submit

May 4, 2023

Conditions

AphakiaPresbyopia

Keywords

IOLCataractAccommodation

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

FAIOL

EXPERIMENTAL

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 LensOther: Top Con Autorefractor

Interventions

Alcon Fluid Accommodating Intraocular LensDEVICE

Intraocular lens intended to treat presbyopia by dynamically adjusting power, resulting in a continuous range of vision from distance to near.

Also known as: FAIOL, FluidVision MX Accommodating IOL
FAIOL
Top Con AutorefractorOTHER

Device intended to automatically determine the focusing characteristics of the eye

FAIOL

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to attend all scheduled study visits as required per protocol
  • years of age or older
  • Bilateral cataracts
  • Corneal astigmatism ≤ 1.25 D
  • Clear intraocular media other than cataract

You may not qualify if:

  • 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:
  • are currently pregnant,
  • have a positive urine pregnancy test result at V0,
  • intend to become pregnant during the study period,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alcon Investigator 8071

San Salvador, 4625, El Salvador

Location

Alcon Investigator 8165

Panama City, Panama

Location

MeSH Terms

Conditions

AphakiaPresbyopiaCataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Clinical Operation Lead CDMA Surgical

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

December 28, 2020

Primary Completion

June 8, 2022

Study Completion

May 3, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)EL(1)