Status:
COMPLETED
A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane d...
Detailed Description
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 9 scheduled study visits over a 7-8 month per...
Eligibility Criteria
Inclusion
- Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logarithm of the minimum angle of resolution (logMAR) (20/40 Snellen) or worse either with or without a glare source present (e.g., Brightness Acuity Tester)
- Preoperative regular astigmatism of \< 1.0 D in both eyes
- Clear intraocular media other than cataract
- Diagnosed with cataract in both eyes
- Planned cataract removal by routine small incision surgery
- Calculated lens power between 18.0 and 25.0 diopter (D) \[when targeted for emmetropia (0.0 D)\]
- Willing and able to complete all required postoperative visits
- Able to comprehend and sign an ethics committee-approved statement of informed consent
- Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator's medical opinion.
Exclusion
- History of eye pathology and/or inflammation, as specified in the protocol
- Clinically significant/severe ocular surface disease that would affect study measurements based on Investigator expert medical opinion
- History of previous intraocular or corneal surgery
- Pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes
- Taking systemic medications that in the Investigator's best medical judgment may confound the outcome or increase the risk to the subject.
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2018
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT03274986
Start Date
October 11 2017
End Date
October 16 2018
Last Update
April 7 2020
Active Locations (11)
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1
Alcon Investigative Site
Birmingham, Alabama, United States, 35213
2
Alcon Investigative Site
Fort Collins, Colorado, United States, 80528
3
Alcon Investigative Site
Bradenton, Florida, United States, 34209
4
Alcon Investigative Site
Sebring, Florida, United States, 33870