Clinical Trials Directory

Trials / Completed

CompletedNCT04330001

Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
99 (actual)
Sponsor
Alcon Research · Industry
Sex
All
Age
22 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEAlcon Fluid Accommodating Intraocular LensIntraocular lens intended to treat presbyopia by dynamically adjusting power, resulting in a continuous range of vision from distance to near.
OTHERTop Con AutorefractorDevice intended to automatically determine the focusing characteristics of the eye

Timeline

Start date
2020-12-28
Primary completion
2022-06-08
Completion
2023-05-03
First posted
2020-04-01
Last updated
2023-05-06

Locations

2 sites across 2 countries: El Salvador, Panama

Source: ClinicalTrials.gov record NCT04330001. Inclusion in this directory is not an endorsement.