Cataract, Presbyopia
Conditions
Keywords
Korea, Trifocal, PanOptix, Bilateral implantation, Cataract, Prospective, Single Arm, ACRYSOF, Model TFNT00
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.
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
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Defocus Curve at Month 3 | 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 planned. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| Binocular 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) | 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. |
| Binocular Defocus Curve at Month 1 | 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. |
| Binocular 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) | 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. |
| Binocular Photopic Best Corrected Contrast Sensitivity With Glare | 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. |
| Binocular Photopic Best Corrected Contrast Sensitivity Without Glare | 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. |
| Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | 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 contact lens for seeing objects at D? Q7:How often do you experience halos? Q8:How severe were these halos? Q9:If you CURRENTLY DRIVE: how much difficulty do you have driving at night? Q10:If you DO NOT DRIVE at night, what is the reason? Q11:How satisfied are you with your cataract surgery result? Q12:Would you recommend cataract surgery and new lenses that were put into your eyes to other people? |
| Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) | 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. |
Countries
South Korea
Participant flow
Recruitment details
Subjects were recruited from 4 study centers located in Korea.
Pre-assignment details
Of the 52 enrolled, 7 subjects exited as screen failures prior to implantation. This reporting group includes all implanted subjects (45).
Participants by arm
| Arm | Count |
|---|---|
| TFNT00 AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TFNT00 |
|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 7.95 |
| Race/Ethnicity, Customized Ethnicity Korean | 45 Participants |
| Race/Ethnicity, Customized Ethnicity Others | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 45 Participants |
| Race/Ethnicity, Customized Race Others | 0 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 | 0 / 44 | 0 / 45 |
| other Total, other adverse events | 1 / 45 | 23 / 45 | 20 / 44 | 3 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 | 1 / 44 | 2 / 45 |
Outcome results
Primary
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.
Time frame: Month 3 (Day 90-120 post second eye implantation)
Population: This analysis population included all subjects with successful bilateral IOL implantation (Full Analysis Set). Number analyzed is the number of subjects with data available for analysis at specified defocus.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Binocular Defocus Curve at Month 3 | -3.0 D | 0.134 logMAR | Standard Deviation 0.085 |
| TFNT00 | Binocular Defocus Curve at Month 3 | -2.0 D | 0.027 logMAR | Standard Deviation 0.0648 |
| TFNT00 | Binocular Defocus Curve at Month 3 | -2.5 D | 0.058 logMAR | Standard Deviation 0.08 |
| TFNT00 | Binocular Defocus Curve at Month 3 | +2.0 D | 0.539 logMAR | Standard Deviation 0.1188 |
| TFNT00 | Binocular Defocus Curve at Month 3 | +1.5 D | 0.364 logMAR | Standard Deviation 0.1241 |
| TFNT00 | Binocular Defocus Curve at Month 3 | +1.0 D | 0.213 logMAR | Standard Deviation 0.1339 |
| TFNT00 | Binocular Defocus Curve at Month 3 | +0.5 D | 0.054 logMAR | Standard Deviation 0.0977 |
| TFNT00 | Binocular Defocus Curve at Month 3 | 0.0 D | -0.049 logMAR | Standard Deviation 0.0697 |
| TFNT00 | Binocular Defocus Curve at Month 3 | -0.5 D | 0.030 logMAR | Standard Deviation 0.0701 |
| TFNT00 | Binocular Defocus Curve at Month 3 | -1.0 D | 0.092 logMAR | Standard Deviation 0.0854 |
| TFNT00 | Binocular Defocus Curve at Month 3 | -1.5 D | 0.060 logMAR | Standard Deviation 0.0917 |
| TFNT00 | Binocular Defocus Curve at Month 3 | -3.5 D | 0.238 logMAR | Standard Deviation 0.0987 |
| TFNT00 | Binocular Defocus Curve at Month 3 | -4.0 D | 0.377 logMAR | Standard Deviation 0.1178 |
| TFNT00 | Binocular Defocus Curve at Month 3 | -4.5 D | 0.510 logMAR | Standard Deviation 0.1367 |
| TFNT00 | Binocular Defocus Curve at Month 3 | -5.0 D | 0.604 logMAR | Standard Deviation 0.1222 |
Secondary
Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)]
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.
Time frame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
Population: Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)] | Month 1 | -0.015 logMAR | Standard Deviation 0.0815 |
| TFNT00 | Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)] | Month 3 | -0.049 logMAR | Standard Deviation 0.0697 |
Secondary
Binocular Defocus Curve at Month 1
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.
Time frame: Month 1 (Day 30-60 post second eye implantation)
Population: Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified defocus.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Binocular Defocus Curve at Month 1 | +2.0 D | 0.581 logMAR | Standard Deviation 0.1689 |
| TFNT00 | Binocular Defocus Curve at Month 1 | +1.5 D | 0.427 logMAR | Standard Deviation 0.1568 |
| TFNT00 | Binocular Defocus Curve at Month 1 | +1.0 D | 0.275 logMAR | Standard Deviation 0.1325 |
| TFNT00 | Binocular Defocus Curve at Month 1 | +0.5 D | 0.111 logMAR | Standard Deviation 0.142 |
| TFNT00 | Binocular Defocus Curve at Month 1 | 0.0 D | -0.015 logMAR | Standard Deviation 0.0815 |
| TFNT00 | Binocular Defocus Curve at Month 1 | -0.5 D | 0.049 logMAR | Standard Deviation 0.0785 |
| TFNT00 | Binocular Defocus Curve at Month 1 | -1.0 D | 0.086 logMAR | Standard Deviation 0.0678 |
| TFNT00 | Binocular Defocus Curve at Month 1 | -1.5 D | 0.093 logMAR | Standard Deviation 0.08 |
| TFNT00 | Binocular Defocus Curve at Month 1 | -2.0 D | 0.080 logMAR | Standard Deviation 0.1046 |
| TFNT00 | Binocular Defocus Curve at Month 1 | -2.5 D | 0.090 logMAR | Standard Deviation 0.1229 |
| TFNT00 | Binocular Defocus Curve at Month 1 | -3.0 D | 0.167 logMAR | Standard Deviation 0.1253 |
| TFNT00 | Binocular Defocus Curve at Month 1 | -3.5 D | 0.264 logMAR | Standard Deviation 0.1455 |
| TFNT00 | Binocular Defocus Curve at Month 1 | -4.0 D | 0.360 logMAR | Standard Deviation 0.1385 |
| TFNT00 | Binocular Defocus Curve at Month 1 | -4.5 D | 0.505 logMAR | Standard Deviation 0.1585 |
| TFNT00 | Binocular Defocus Curve at Month 1 | -5.0 D | 0.640 logMAR | Standard Deviation 0.1358 |
Secondary
Binocular Photopic Best Corrected Contrast Sensitivity With Glare
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.
Time frame: Month 3 (Day 90-120 post second eye implantation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Binocular Photopic Best Corrected Contrast Sensitivity With Glare | 3 cpd | 1.673 log unit | Standard Deviation 0.1316 |
| TFNT00 | Binocular Photopic Best Corrected Contrast Sensitivity With Glare | 6 cpd | 1.907 log unit | Standard Deviation 0.1691 |
| TFNT00 | Binocular Photopic Best Corrected Contrast Sensitivity With Glare | 12 cpd | 1.539 log unit | Standard Deviation 0.2113 |
| TFNT00 | Binocular Photopic Best Corrected Contrast Sensitivity With Glare | 18 cpd | 1.139 log unit | Standard Deviation 0.2038 |
Secondary
Binocular Photopic Best Corrected Contrast Sensitivity Without Glare
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.
Time frame: Month 3 (Day 90-120 post second eye implantation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Binocular Photopic Best Corrected Contrast Sensitivity Without Glare | 3 cpd | 1.676 log unit | Standard Deviation 0.1647 |
| TFNT00 | Binocular Photopic Best Corrected Contrast Sensitivity Without Glare | 6 cpd | 1.878 log unit | Standard Deviation 0.1747 |
| TFNT00 | Binocular Photopic Best Corrected Contrast Sensitivity Without Glare | 12 cpd | 1.588 log unit | Standard Deviation 0.2317 |
| TFNT00 | Binocular Photopic Best Corrected Contrast Sensitivity Without Glare | 18 cpd | 1.133 log unit | Standard Deviation 0.2268 |
Secondary
Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)
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.
Time frame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
Population: Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | Month 1 | 0.049 logMAR | Standard Deviation 0.1071 |
| TFNT00 | Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | Month 3 | 0.026 logMAR | Standard Deviation 0.0987 |
Secondary
Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm)
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.
Time frame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) | Month 1 | 0.015 logMAR | Standard Deviation 0.1242 |
| TFNT00 | Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) | Month 3 | -0.025 logMAR | Standard Deviation 0.1113 |
Secondary
Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)
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.
Time frame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | Month 1 | 0.047 logMAR | Standard Deviation 0.1221 |
| TFNT00 | Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | Month 3 | 0.029 logMAR | Standard Deviation 0.1222 |
Secondary
Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)
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.
Time frame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
Population: This analysis population included all subjects with successful implantation of the test product in at least one eye (All-implanted Analysis Set). Number analyzed is the number of subjects/eyes with data available for analysis at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | Month 1 | 0.089 logMAR | Standard Deviation 0.1203 |
| TFNT00 | Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | Month 3 | 0.073 logMAR | Standard Deviation 0.1002 |
| TFNT00 Second Eye | Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | Month 1 | 0.097 logMAR | Standard Deviation 0.1078 |
| TFNT00 Second Eye | Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) | Month 3 | 0.081 logMAR | Standard Deviation 0.1328 |
Secondary
Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)]
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.
Time frame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
Population: All-implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] | Month 1 | 0.080 logMAR | Standard Deviation 0.1493 |
| TFNT00 | Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] | Month 3 | 0.054 logMAR | Standard Deviation 0.1217 |
| TFNT00 Second Eye | Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] | Month 1 | 0.080 logMAR | Standard Deviation 0.1407 |
| TFNT00 Second Eye | Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] | Month 3 | 0.035 logMAR | Standard Deviation 0.1295 |
Secondary
Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)
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.
Time frame: Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)
Population: All-implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | Month 1 | 0.116 logMAR | Standard Deviation 0.1284 |
| TFNT00 | Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | Month 3 | 0.089 logMAR | Standard Deviation 0.1334 |
| TFNT00 Second Eye | Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | Month 1 | 0.104 logMAR | Standard Deviation 0.1219 |
| TFNT00 Second Eye | Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) | Month 3 | 0.091 logMAR | Standard Deviation 0.1226 |
Secondary
Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs)
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 contact lens for seeing objects at D? Q7:How often do you experience halos? Q8:How severe were these halos? Q9:If you CURRENTLY DRIVE: how much difficulty do you have driving at night? Q10:If you DO NOT DRIVE at night, what is the reason? Q11:How satisfied are you with your cataract surgery result? Q12:Would you recommend cataract surgery and new lenses that were put into your eyes to other people?
Time frame: Preoperative and Month 3 (Day 90-120 post second eye implantation)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q9: Extreme difficulty | 25.0 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q1: Very dissatisfied | 47.7 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q1: Dissatisfied | 40.9 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q1: Neither satisfied nor dissatisfied | 6.8 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q1: Satisfied | 4.5 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q1: Very satisfied | 0.0 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q2: None of the time | 15.9 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q2: Some of the time | 15.9 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q2: Most of the time | 25.0 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q2: All of the time | 43.2 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q3: Very dissatisfied | 25.0 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q3: Dissatisfied | 61.4 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q3: Neither satisfied nor dissatisfied | 6.8 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q3: Satisfied | 6.8 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q3: Very satisfied | 0.0 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q4: None of the time | 20.5 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q4: Some of the time | 27.3 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q4: Most of the time | 25.0 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q4: All of the time | 27.3 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q5: Very dissatisfied | 20.5 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q5: Dissatisfied | 43.2 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q5: Neither satisfied nor dissatisfied | 25.0 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q5: Satisfied | 11.4 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q5: Very satisfied | 0.0 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q6: None of the time | 31.8 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q6: Some of the time | 20.5 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q6: Most of the time | 11.4 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q6: All of the time | 36.4 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q7: None of the time | 22.7 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q7: Some of the time | 45.5 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q7: Most of the time | 22.7 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q7: All of the time | 9.1 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q8: None | 20.5 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q8: Mild | 29.5 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q8: Moderate | 34.1 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q8: Severe | 15.9 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q9: No difficulty at all | 11.4 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q9: A little difficulty | 11.4 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q9: Moderate difficulty | 29.5 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q9: NA : I do not drive at night | 22.7 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q10: Because of your current eyesight | 27.3 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q10: Because you are not interested in driving | 11.4 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q10: Because you have other reasons | 22.7 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q10: NA: I drive at night | 38.6 percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q11: Very dissatisfied | NA percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q11: Dissatisfied | NA percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q11: Neither satisfied nor dissatisfied | NA percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q11: Satisfied | NA percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q11: Very satisfied | NA percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q12: No | NA percentage of subjects |
| TFNT00 | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q12: Yes | NA percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q11: Dissatisfied | 2.3 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q6: Most of the time | 0.0 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q1: Very dissatisfied | 2.3 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q9: Extreme difficulty | 22.7 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q1: Dissatisfied | 4.5 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q6: All of the time | 2.3 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q1: Neither satisfied nor dissatisfied | 9.1 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q11: Very dissatisfied | 4.5 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q1: Satisfied | 63.6 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q7: None of the time | 6.8 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q1: Very satisfied | 20.5 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q9: NA : I do not drive at night | 31.8 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q2: None of the time | 84.1 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q7: Some of the time | 25.0 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q2: Some of the time | 13.6 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q12: No | 36.4 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q2: Most of the time | 0.0 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q7: Most of the time | 34.1 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q2: All of the time | 2.3 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q10: Because of your current eyesight | 25.0 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q3: Very dissatisfied | 2.3 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q7: All of the time | 34.1 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q3: Dissatisfied | 9.1 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q11: Very satisfied | 20.5 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q3: Neither satisfied nor dissatisfied | 11.4 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q8: None | 6.8 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q3: Satisfied | 56.8 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q10: Because you are not interested in driving | 11.4 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q3: Very satisfied | 20.5 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q8: Mild | 11.4 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q4: None of the time | 90.9 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q11: Neither satisfied nor dissatisfied | 18.2 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q4: Some of the time | 6.8 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q8: Moderate | 50.0 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q4: Most of the time | 0.0 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q10: Because you have other reasons | 27.3 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q4: All of the time | 2.3 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q8: Severe | 31.8 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q5: Very dissatisfied | 2.3 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q12: Yes | 63.6 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q5: Dissatisfied | 6.8 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q9: No difficulty at all | 9.1 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q5: Neither satisfied nor dissatisfied | 20.5 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q10: NA: I drive at night | 36.4 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q5: Satisfied | 59.1 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q9: A little difficulty | 11.4 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q5: Very satisfied | 11.4 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q11: Satisfied | 54.5 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q6: None of the time | 95.5 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q9: Moderate difficulty | 25.0 percentage of subjects |
| TFNT00 Second Eye | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) | Q6: Some of the time | 2.3 percentage of subjects |