Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

Alcon

Status: Completed

Conditions: Presbyopia; Aphakia

Treatments: Device: Alcon Fluid Accommodating Intraocular Lens; Other: Top Con Autorefractor

Study type: Interventional

Funder types: Industry

Identifiers

NCT04330001

ILR286-E003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 22+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

FAIOL

Experimental group

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.

Treatment:

Other: Top Con Autorefractor

Device: Alcon Fluid Accommodating Intraocular Lens