Status:
COMPLETED
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Presbyopia
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this study is to confirm the effectiveness of the investigational lens in a Korean population, especially for visual performance, quality of vision, and subject satisfaction with the vi...
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 study visits over a 4-5-month period. Of th...
Eligibility Criteria
Inclusion
- Requires cataract extraction in both eyes
- Clear intraocular media other than cataracts in both eyes
- Calculated lens power between +16.0 and +24.0 diopter (D)
- Preoperative OR expected postoperative regular corneal astigmatism of \< 1.00 D.
Exclusion
- Pregnant or lactating
- Any clinically significant corneal abnormality, per the Investigator's expert medical opinion
- Previous corneal transplant; previous ocular trauma; previous refractive surgery
- History of, concurrent, or predisposition to retinal conditions, such as diabetic retinopathy, diabetic macular edema, or macular degeneration.
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2018
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03268746
Start Date
January 9 2018
End Date
November 30 2018
Last Update
September 25 2019
Active Locations (4)
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1
Alcon Investigative Site
Seongnam-si, South Korea, 13620
2
Alcon Investigative Site
Seoul, South Korea, 03722
3
Alcon Investigative Site
Seoul, South Korea, 05505
4
Alcon Investigative Site
Seoul, South Korea, 06351