Clinical trial NCT03268746: Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population
Official title: Clinical Investigation of the Visual Outcomes and Safety After Bilateral Implantation of a Trifocal Presbyopia Correcting IOL in a Korean Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Presbyopia
Keywords: Korea
Trifocal
PanOptix
Bilateral implantation
Cataract
Prospective
Single Arm
ACRYSOF
Model TFNT00
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-08-31
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

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.

Primary outcomes:
measure: Binocular Defocus Curve at Month 3
timeFrame: Month 3 (Day 90-120 post second eye implantation)
Secondary outcomes:
measure: Binocular Defocus Curve at Month 1
timeFrame: Month 1 (Day 30-60 post second eye implantation)
measure: Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)]
timeFrame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
measure: Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)
timeFrame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
measure: Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)]
timeFrame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
measure: Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)
timeFrame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
measure: Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)
timeFrame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
measure: Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm)
timeFrame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
measure: Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)
timeFrame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
measure: Binocular Photopic Best Corrected Contrast Sensitivity With Glare
timeFrame: Month 3 (Day 90-120 post second eye implantation)
measure: Binocular Photopic Best Corrected Contrast Sensitivity Without Glare
timeFrame: Month 3 (Day 90-120 post second eye implantation)
measure: Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs)
timeFrame: Preoperative and Month 3 (Day 90-120 post second eye implantation)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Alcon Investigative Site
city: Seoul
country: Korea, Republic of
facility: Alcon Investigative Site
city: Seoul
country: Korea, Republic of
facility: Alcon Investigative Site
city: Seoul
country: Korea, Republic of
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Research
name: Alcon Research
role: STUDY_DIRECTOR
References:
citation: 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.