Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Multifocal IOL AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes will be implanted. |
Device: AcrySof IQ PanOptix Multifocal IOL
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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 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.
- 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?
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigative Site | Seongnam-si | Korea, Republic of | 13620 | |
| 2 | Alcon Investigative Site | Seoul | Korea, Republic of | 03722 | |
| 3 | Alcon Investigative Site | Seoul | Korea, Republic of | 05505 | |
| 4 | Alcon Investigative Site | Seoul | Korea, Republic of | 06351 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Alcon Research, Alcon Research
Study Documents (Full-Text)
More Information
Publications
None provided.- ILH297-P004
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from 4 study centers located in Korea. |
|---|---|
| Pre-assignment Detail | Of the 52 enrolled, 7 subjects exited as screen failures prior to implantation. This reporting group includes all implanted subjects (45). |
| Arm/Group Title | TFNT00 |
|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal intraocular lens (IOL) Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Period Title: Overall Study | |
| STARTED | 45 |
| COMPLETED | 44 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | TFNT00 |
|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Overall Participants | 45 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
59.7
(7.95)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
34
75.6%
|
| Male |
11
24.4%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Asian |
45
100%
|
| Others |
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Korean |
45
100%
|
| Others |
0
0%
|
Outcome Measures
| Title | Binocular Defocus Curve at Month 3 |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | TFNT00 |
|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Measure Participants | 44 |
| +2.0 D |
0.539
(0.1188)
|
| +1.5 D |
0.364
(0.1241)
|
| +1.0 D |
0.213
(0.1339)
|
| +0.5 D |
0.054
(0.0977)
|
| 0.0 D |
-0.049
(0.0697)
|
| -0.5 D |
0.030
(0.0701)
|
| -1.0 D |
0.092
(0.0854)
|
| -1.5 D |
0.060
(0.0917)
|
| -2.0 D |
0.027
(0.0648)
|
| -2.5 D |
0.058
(0.0800)
|
| -3.0 D |
0.134
(0.0850)
|
| -3.5 D |
0.238
(0.0987)
|
| -4.0 D |
0.377
(0.1178)
|
| -4.5 D |
0.510
(0.1367)
|
| -5.0 D |
0.604
(0.1222)
|
| Title | Binocular Defocus Curve at Month 1 |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified defocus. |
| Arm/Group Title | TFNT00 |
|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Measure Participants | 44 |
| +2.0 D |
0.581
(0.1689)
|
| +1.5 D |
0.427
(0.1568)
|
| +1.0 D |
0.275
(0.1325)
|
| +0.5 D |
0.111
(0.1420)
|
| 0.0 D |
-0.015
(0.0815)
|
| -0.5 D |
0.049
(0.0785)
|
| -1.0 D |
0.086
(0.0678)
|
| -1.5 D |
0.093
(0.0800)
|
| -2.0 D |
0.080
(0.1046)
|
| -2.5 D |
0.090
(0.1229)
|
| -3.0 D |
0.167
(0.1253)
|
| -3.5 D |
0.264
(0.1455)
|
| -4.0 D |
0.360
(0.1385)
|
| -4.5 D |
0.505
(0.1585)
|
| -5.0 D |
0.640
(0.1358)
|
| Title | Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)] |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified time point. |
| Arm/Group Title | TFNT00 |
|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Measure Participants | 44 |
| Month 1 |
-0.015
(0.0815)
|
| Month 3 |
-0.049
(0.0697)
|
| Title | Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | TFNT00 First Eye | TFNT00 Second Eye |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the first eye | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye |
| Measure Participants | 45 | 44 |
| Measure Eyes | 45 | 44 |
| Month 1 |
0.089
(0.1203)
|
0.097
(0.1078)
|
| Month 3 |
0.073
(0.1002)
|
0.081
(0.1328)
|
| Title | Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)] |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified time point. |
| Arm/Group Title | TFNT00 First Eye | TFNT00 Second Eye |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the first eye | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye |
| Measure Participants | 45 | 44 |
| Measure Eyes | 45 | 44 |
| Month 1 |
0.080
(0.1493)
|
0.080
(0.1407)
|
| Month 3 |
0.054
(0.1217)
|
0.035
(0.1295)
|
| Title | Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified time point. |
| Arm/Group Title | TFNT00 First Eye | TFNT00 Second Eye |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the first eye | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye |
| Measure Participants | 45 | 44 |
| Measure Eyes | 45 | 44 |
| Month 1 |
0.116
(0.1284)
|
0.104
(0.1219)
|
| Month 3 |
0.089
(0.1334)
|
0.091
(0.1226)
|
| Title | Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified time point. |
| Arm/Group Title | TFNT00 |
|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Measure Participants | 44 |
| Month 1 |
0.049
(0.1071)
|
| Month 3 |
0.026
(0.0987)
|
| Title | Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | TFNT00 |
|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Measure Participants | 44 |
| Month 1 |
0.015
(0.1242)
|
| Month 3 |
-0.025
(0.1113)
|
| Title | Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | TFNT00 |
|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Measure Participants | 44 |
| Month 1 |
0.047
(0.1221)
|
| Month 3 |
0.029
(0.1222)
|
| Title | Binocular Photopic Best Corrected Contrast Sensitivity With Glare |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | TFNT00 |
|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Measure Participants | 44 |
| 3 cpd |
1.673
(0.1316)
|
| 6 cpd |
1.907
(0.1691)
|
| 12 cpd |
1.539
(0.2113)
|
| 18 cpd |
1.139
(0.2038)
|
| Title | Binocular Photopic Best Corrected Contrast Sensitivity Without Glare |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | TFNT00 |
|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes were implanted |
| Measure Participants | 44 |
| 3 cpd |
1.676
(0.1647)
|
| 6 cpd |
1.878
(0.1747)
|
| 12 cpd |
1.588
(0.2317)
|
| 18 cpd |
1.133
(0.2268)
|
| Title | Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) |
| Arm/Group Title | TFNT00 Preoperative | TFNT00 Month 3 |
|---|---|---|
| Arm/Group Description | All subjects in FAS prior to initiation of treatment | All subjects in FAS who responded at Month 3 |
| Measure Participants | 44 | 44 |
| Q1: Very dissatisfied |
47.7
|
2.3
|
| Q1: Dissatisfied |
40.9
|
4.5
|
| Q1: Neither satisfied nor dissatisfied |
6.8
|
9.1
|
| Q1: Satisfied |
4.5
|
63.6
|
| Q1: Very satisfied |
0.0
|
20.5
|
| Q2: None of the time |
15.9
|
84.1
|
| Q2: Some of the time |
15.9
|
13.6
|
| Q2: Most of the time |
25.0
|
0.0
|
| Q2: All of the time |
43.2
|
2.3
|
| Q3: Very dissatisfied |
25.0
|
2.3
|
| Q3: Dissatisfied |
61.4
|
9.1
|
| Q3: Neither satisfied nor dissatisfied |
6.8
|
11.4
|
| Q3: Satisfied |
6.8
|
56.8
|
| Q3: Very satisfied |
0.0
|
20.5
|
| Q4: None of the time |
20.5
|
90.9
|
| Q4: Some of the time |
27.3
|
6.8
|
| Q4: Most of the time |
25.0
|
0.0
|
| Q4: All of the time |
27.3
|
2.3
|
| Q5: Very dissatisfied |
20.5
|
2.3
|
| Q5: Dissatisfied |
43.2
|
6.8
|
| Q5: Neither satisfied nor dissatisfied |
25.0
|
20.5
|
| Q5: Satisfied |
11.4
|
59.1
|
| Q5: Very satisfied |
0.0
|
11.4
|
| Q6: None of the time |
31.8
|
95.5
|
| Q6: Some of the time |
20.5
|
2.3
|
| Q6: Most of the time |
11.4
|
0.0
|
| Q6: All of the time |
36.4
|
2.3
|
| Q7: None of the time |
22.7
|
6.8
|
| Q7: Some of the time |
45.5
|
25.0
|
| Q7: Most of the time |
22.7
|
34.1
|
| Q7: All of the time |
9.1
|
34.1
|
| Q8: None |
20.5
|
6.8
|
| Q8: Mild |
29.5
|
11.4
|
| Q8: Moderate |
34.1
|
50.0
|
| Q8: Severe |
15.9
|
31.8
|
| Q9: No difficulty at all |
11.4
|
9.1
|
| Q9: A little difficulty |
11.4
|
11.4
|
| Q9: Moderate difficulty |
29.5
|
25.0
|
| Q9: Extreme difficulty |
25.0
|
22.7
|
| Q9: NA : I do not drive at night |
22.7
|
31.8
|
| Q10: Because of your current eyesight |
27.3
|
25.0
|
| Q10: Because you are not interested in driving |
11.4
|
11.4
|
| Q10: Because you have other reasons |
22.7
|
27.3
|
| Q10: NA: I drive at night |
38.6
|
36.4
|
| Q11: Very dissatisfied |
NA
|
4.5
|
| Q11: Dissatisfied |
NA
|
2.3
|
| Q11: Neither satisfied nor dissatisfied |
NA
|
18.2
|
| Q11: Satisfied |
NA
|
54.5
|
| Q11: Very satisfied |
NA
|
20.5
|
| Q12: No |
NA
|
36.4
|
| Q12: Yes |
NA
|
63.6
|
Adverse Events
| Time Frame | Pre-operation through study completion, an average of 7 months | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes. | |||||||
| Arm/Group Title | Preoperative | TFNT00 First Eye | TFNT00 Second Eye | TFNT00 Systemic | ||||
| Arm/Group Description | All subjects in the safety analysis set prior to initiation of treatment | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the first eye | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Implantation in the second eye | All subjects with attempted test article implantation (successful or aborted after contact with the eye) | ||||
All Cause Mortality |
||||||||
| Preoperative | TFNT00 First Eye | TFNT00 Second Eye | TFNT00 Systemic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | 0/45 (0%) | ||||
Serious Adverse Events |
||||||||
| Preoperative | TFNT00 First Eye | TFNT00 Second Eye | TFNT00 Systemic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/45 (0%) | 0/45 (0%) | 1/44 (2.3%) | 2/45 (4.4%) | ||||
| Gastrointestinal disorders | ||||||||
| Diverticulum intestinal haemorrhagic | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | 1/45 (2.2%) | ||||
| Product Issues | ||||||||
| Device dislocation | 0/45 (0%) | 0/45 (0%) | 1/44 (2.3%) | 0/45 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Dyspnoea | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | 1/45 (2.2%) | ||||
| Surgical and medical procedures | ||||||||
| Surgery | 0/45 (0%) | 0/45 (0%) | 1/44 (2.3%) | 0/45 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Preoperative | TFNT00 First Eye | TFNT00 Second Eye | TFNT00 Systemic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/45 (2.2%) | 23/45 (51.1%) | 20/44 (45.5%) | 3/45 (6.7%) | ||||
| Eye disorders | ||||||||
| Dry eye | 0/45 (0%) | 11/45 (24.4%) | 10/44 (22.7%) | 0/45 (0%) | ||||
| Glare | 0/45 (0%) | 10/45 (22.2%) | 9/44 (20.5%) | 0/45 (0%) | ||||
| Visual impairment | 1/45 (2.2%) | 3/45 (6.7%) | 3/44 (6.8%) | 0/45 (0%) | ||||
| Halo vision | 0/45 (0%) | 3/45 (6.7%) | 3/44 (6.8%) | 0/45 (0%) | ||||
| Foreign body sensation in eyes | 0/45 (0%) | 3/45 (6.7%) | 2/44 (4.5%) | 0/45 (0%) | ||||
| Vitreous floaters | 0/45 (0%) | 2/45 (4.4%) | 3/44 (6.8%) | 0/45 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | 3/45 (6.7%) | ||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Clinical/Brand Lead |
|---|---|
| Organization | Alcon Research |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
- ILH297-P004