Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

NCT ID: NCT04330001

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-28
• Study Completion Date: 2023-05-03

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.

Conditions

Aphakia; Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Alcon Fluid Accommodating Intraocular Lens

Intervention Type: DEVICE

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

Top Con Autorefractor

Intervention Type: OTHER

Device intended to automatically determine the focusing characteristics of the eye

Interventions

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.

Intervention Type: DEVICE

Top Con Autorefractor

Device intended to automatically determine the focusing characteristics of the eye

Intervention Type: OTHER

Other Intervention Names

FAIOL; FluidVision MX Accommodating IOL

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

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Operation Lead CDMA Surgical

Role: STUDY_DIRECTOR

Alcon Research

Locations

Alcon Investigator 8071

San Salvador, , El Salvador

Alcon Investigator 8165

Panama City, , Panama

Countries

El Salvador; Panama

Other Identifiers

ILR286-E003

Identifier Type: -

Identifier Source: org_study_id