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Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

Primary Purpose

Aphakia, Presbyopia

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Alcon Fluid Accommodating Intraocular Lens

Top Con Autorefractor

About this trial

This is an interventional other trial for Aphakia focused on measuring IOL, Cataract, Accommodation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Alcon Investigator 8071
Alcon Investigator 8165

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FAIOL

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT04330001

First Posted

March 30, 2020

Last Updated

May 4, 2023

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT04330001

Brief Title

Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

Official Title

Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

December 28, 2020 (Actual)

Primary Completion Date

June 8, 2022 (Actual)

Study Completion Date

May 3, 2023 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aphakia, Presbyopia

Keywords

IOL, Cataract, Accommodation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FAIOL

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Alcon Fluid Accommodating Intraocular Lens

Other Intervention Name(s)

FAIOL, FluidVision MX Accommodating IOL

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Top Con Autorefractor

Intervention Description

Device intended to automatically determine the focusing characteristics of the eye

Primary Outcome Measure Information:

Title

Repeatability of objective refraction

Description

Time Frame

Month 1 (post 2nd eye implant)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 Other protocol-specified exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Operation Lead CDMA Surgical

Organizational Affiliation

Alcon Research

Official's Role

Study Director

Facility Information:

Facility Name

Alcon Investigator 8071

City

San Salvador

ZIP/Postal Code

4625

Country

El Salvador

Facility Name

Alcon Investigator 8165

City

Panamá

Country

Panama

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

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