N/A
Completed N=45
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population
Source: ClinicalTrials.gov NCT03268746 ↗Enrolled (actual)
45
Serious AEs
1.7%
Results posted
Sep 2019
Primary outcomePrimary: Binocular Defocus Curve at Month 3 — 0.539; 0.364; 0.213; 0.054 logMAR
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 visual outcome, as well as the safety of the lens. This trial will be conducted in Korea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Defocus Curve at Month 3 |
0.539; 0.364; 0.213; 0.054; -0.049; 0.030 | — |
| SECONDARY Binocular Defocus Curve at Month 1 |
0.581; 0.427; 0.275; 0.111; -0.015; 0.049 | — |
| SECONDARY Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)] |
-0.015; -0.049 | — |
| SECONDARY Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) |
0.089; 0.097; 0.073; 0.081 | — |
| SECONDARY Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] |
0.080; 0.080; 0.054; 0.035 | — |
| SECONDARY Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) |
0.116; 0.104; 0.089; 0.091 | — |
| SECONDARY Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) |
0.049; 0.026 | — |
| SECONDARY Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) |
0.015; -0.025 | — |
| SECONDARY Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) |
0.047; 0.029 | — |
| SECONDARY Binocular Photopic Best Corrected Contrast Sensitivity With Glare |
1.673; 1.907; 1.539; 1.139 | — |
| SECONDARY Binocular Photopic Best Corrected Contrast Sensitivity Without Glare |
1.676; 1.878; 1.588; 1.133 | — |
| SECONDARY Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) |
47.7; 2.3; 40.9; 4.5; 6.8; 9.1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03268746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.