Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population
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Details and patient eligibility
About
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 visual outcome, as well as the safety of the lens. This trial will be conducted in Korea.
Full 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 these 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 3 visit (Day 90-120 post second eye implantation). The second eye implantation will occur 2-30 days after the first implantation.
Enrollment
Sex
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Volunteers
Inclusion criteria
- 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 criteria
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
52 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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