Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population
1 other identifier
interventional
52
1 country
4
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 visual outcome, as well as the safety of the lens. This trial will be conducted in Korea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedStudy Start
First participant enrolled
January 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedResults Posted
Study results publicly available
September 25, 2019
CompletedSeptember 25, 2019
August 1, 2019
11 months
August 30, 2017
August 30, 2019
August 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Binocular Defocus Curve at Month 3
The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. The visual acuity (VA) at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned.
Month 3 (Day 90-120 post second eye implantation)
Secondary Outcomes (11)
Binocular Defocus Curve at Month 1
Month 1 (Day 30-60 post second eye implantation)
Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)]
Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)
Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)]
Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)
Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
- +6 more secondary outcomes
Study Arms (1)
Multifocal IOL
EXPERIMENTALAcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes will be implanted.
Interventions
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision intended for long-term use over the lifetime of the cataract subject
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (4)
Alcon Investigative Site
Seongnam-si, 13620, South Korea
Alcon Investigative Site
Seoul, 03722, South Korea
Alcon Investigative Site
Seoul, 05505, South Korea
Alcon Investigative Site
Seoul, 06351, South Korea
Related Publications (1)
Kim TI, Chung TY, Kim MJ, Lee K, Hyon JY. Visual outcomes and safety after bilateral implantation of a trifocal presbyopia correcting intraocular lens in a Korean population: a prospective single-arm study. BMC Ophthalmol. 2020 Jul 15;20(1):288. doi: 10.1186/s12886-020-01549-z.
PMID: 32669090DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical/Brand Lead
- Organization
- Alcon Research
Study Officials
- STUDY DIRECTOR
Alcon Research
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2017
First Posted
August 31, 2017
Study Start
January 9, 2018
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
September 25, 2019
Results First Posted
September 25, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share