20 and older, any sex, with Cataract or Presbyopia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Binocular Defocus Curve at Month 3Primary· Month 3 (Day 90-120 post second eye implantation)
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
+2.0 D
Group
Value
95% CI
TFNT00
0.539
± 0.1188
+1.5 D
Group
Value
95% CI
TFNT00
0.364
± 0.1241
+1.0 D
Group
Value
95% CI
TFNT00
0.213
± 0.1339
+0.5 D
Group
Value
95% CI
TFNT00
0.054
± 0.0977
0.0 D
Group
Value
95% CI
TFNT00
-0.049
± 0.0697
-0.5 D
Group
Value
95% CI
TFNT00
0.030
± 0.0701
-1.0 D
Group
Value
95% CI
TFNT00
0.092
± 0.0854
-1.5 D
Group
Value
95% CI
TFNT00
0.060
± 0.0917
Binocular Defocus Curve at Month 1Secondary· Month 1 (Day 30-60 post second eye implantation)
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. VA at each spherical power was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned.
+2.0 D
Group
Value
95% CI
TFNT00
0.581
± 0.1689
+1.5 D
Group
Value
95% CI
TFNT00
0.427
± 0.1568
+1.0 D
Group
Value
95% CI
TFNT00
0.275
± 0.1325
+0.5 D
Group
Value
95% CI
TFNT00
0.111
± 0.1420
0.0 D
Group
Value
95% CI
TFNT00
-0.015
± 0.0815
-0.5 D
Group
Value
95% CI
TFNT00
0.049
± 0.0785
-1.0 D
Group
Value
95% CI
TFNT00
0.086
± 0.0678
-1.5 D
Group
Value
95% CI
TFNT00
0.093
± 0.0800
Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)]Secondary· Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
VA was tested binocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters from the spectacle plane. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.
Month 1
Group
Value
95% CI
TFNT00
-0.015
± 0.0815
Month 3
Group
Value
95% CI
TFNT00
-0.049
± 0.0697
Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)Secondary· Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
VA was tested monocularly (each eye separately) under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.
Month 1
Group
Value
95% CI
TFNT00 First Eye
0.089
± 0.1203
TFNT00 Second Eye
0.097
± 0.1078
Month 3
Group
Value
95% CI
TFNT00 First Eye
0.073
± 0.1002
TFNT00 Second Eye
0.081
± 0.1328
Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)]Secondary· Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.
Month 1
Group
Value
95% CI
TFNT00 First Eye
0.080
± 0.1493
TFNT00 Second Eye
0.080
± 0.1407
Month 3
Group
Value
95% CI
TFNT00 First Eye
0.054
± 0.1217
TFNT00 Second Eye
0.035
± 0.1295
Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)Secondary· Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.
Month 1
Group
Value
95% CI
TFNT00 First Eye
0.116
± 0.1284
TFNT00 Second Eye
0.104
± 0.1219
Month 3
Group
Value
95% CI
TFNT00 First Eye
0.089
± 0.1334
TFNT00 Second Eye
0.091
± 0.1226
Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)Secondary· Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.
Month 1
Group
Value
95% CI
TFNT00
0.049
± 0.1071
Month 3
Group
Value
95% CI
TFNT00
0.026
± 0.0987
Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm)Secondary· Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.
Month 1
Group
Value
95% CI
TFNT00
0.015
± 0.1242
Month 3
Group
Value
95% CI
TFNT00
-0.025
± 0.1113
Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)Secondary· Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.
Month 1
Group
Value
95% CI
TFNT00
0.047
± 0.1221
Month 3
Group
Value
95% CI
TFNT00
0.029
± 0.1222
Binocular Photopic Best Corrected Contrast Sensitivity With GlareSecondary· Month 3 (Day 90-120 post second eye implantation)
Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned.
3 cpd
Group
Value
95% CI
TFNT00
1.673
± 0.1316
6 cpd
Group
Value
95% CI
TFNT00
1.907
± 0.1691
12 cpd
Group
Value
95% CI
TFNT00
1.539
± 0.2113
18 cpd
Group
Value
95% CI
TFNT00
1.139
± 0.2038
Binocular Photopic Best Corrected Contrast Sensitivity Without GlareSecondary· Month 3 (Day 90-120 post second eye implantation)
Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cpd using the Vector Vision CSV 1000-HGT without a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned.
3 cpd
Group
Value
95% CI
TFNT00
1.676
± 0.1647
6 cpd
Group
Value
95% CI
TFNT00
1.878
± 0.1747
12 cpd
Group
Value
95% CI
TFNT00
1.588
± 0.2317
18 cpd
Group
Value
95% CI
TFNT00
1.133
± 0.2268
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs)Secondary· Preoperative and Month 3 (Day 90-120 post second eye implantation)
Subjects responded to 12 SSQs based on their experience during past 7 days for quality of vision and any change since cataract surgery as follows; Q1:How satisfied are you with your vision for seeing objects at near distance(ND)? Q2:How often do you wear eyeglasses or contact lenses for seeing objects at ND? Q3:How satisfied are you with your vision for seeing objects at intermediate distance(ID)? Q4:How often do you wear eyeglasses or contact lens for seeing objects at ID? Q5:How satisfied are you with your vision for seeing objects at distance(D)? Q6:How often do you wear eyeglasses or conta
Q1: Very dissatisfied
Group
Value
95% CI
TFNT00 Preoperative
47.7
TFNT00 Month 3
2.3
Q1: Dissatisfied
Group
Value
95% CI
TFNT00 Preoperative
40.9
TFNT00 Month 3
4.5
Q1: Neither satisfied nor dissatisfied
Group
Value
95% CI
TFNT00 Preoperative
6.8
TFNT00 Month 3
9.1
Q1: Satisfied
Group
Value
95% CI
TFNT00 Preoperative
4.5
TFNT00 Month 3
63.6
Q1: Very satisfied
Group
Value
95% CI
TFNT00 Preoperative
0.0
TFNT00 Month 3
20.5
Q2: None of the time
Group
Value
95% CI
TFNT00 Preoperative
15.9
TFNT00 Month 3
84.1
Q2: Some of the time
Group
Value
95% CI
TFNT00 Preoperative
15.9
TFNT00 Month 3
13.6
Q2: Most of the time
Group
Value
95% CI
TFNT00 Preoperative
25.0
TFNT00 Month 3
0.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Pre-operation through study completion, an average of 7 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alcon Research
Last refreshed: 25 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03268746.