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The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.
Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TFNT00 | Experimental | AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation |
|
| 839MP | Active Comparator | AT LISA® tri IOL, bilateral implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL | Device | Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180 | VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA 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 ETDRS chart. A lower numeric value represents better visual acuity. | Day 120-180 from second eye implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Binocular UCIVA (60cm) at Day 120-180 | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. 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 represents better visual acuity. | Day 120-180 from second eye implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Manager, GCRA | Alcon, a Novartis Company | Study Director |
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Of the 215 enrolled, 26 subjects were exited as screen failures and 1 subject died prior to randomization. This reporting group includes all randomized subjects (188).
Subjects were recruited from 15 study centers located in Australia (3), Brazil (3), Spain (3), Denmark (2), Colombia (2), United Kingdom (1), and the Netherlands (1).
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| ID | Title | Description |
|---|---|---|
| FG000 | TFNT00 | AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation |
| FG001 | 839MP | AT LISA® tri IOL, bilateral implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All-Implanted Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | TFNT00 | AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation |
| BG001 | 839MP | AT LISA® tri IOL, bilateral implantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180 | VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA 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 ETDRS chart. A lower numeric value represents better visual acuity. | All-Implanted Analysis Set | Posted | Least Squares Mean | Standard Error | logMAR | Day 120-180 from second eye implantation |
|
IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TFNT00 - 1st Eye | First eye implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Halo vision | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Global Brand Medical Affairs Lead, CDMA Surgical | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2016 | Jan 11, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 24, 2016 | Sep 25, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| AT LISA® tri IOL | Device | Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient |
|
|
| Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180 | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. 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 represents better visual acuity. | Day 120-180 from second eye implantation |
| Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180 | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. 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 represents better visual acuity. | Day 120-180 from second eye implantation |
| Mean Photopic Binocular Defocus Curve at Day 120-180 | A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed. | Day 120-180 from second eye implantation |
| Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Day 120-180 from second eye implantation |
| Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Day 120-180 from second eye implantation |
| Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Day 120-180 from second eye implantation |
| Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Day 120-180 from second eye implantation |
| Subject Satisfaction Recorded at Day 120-180 | At the Month 6 Visit, subjects responded to the question: "Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?". Responses were reported as a percentage of subjects. No statistical test was performed. | Day 120-180 from second eye implantation |
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
AT LISA® tri IOL, bilateral implantation |
|
|
|
| Secondary | Least Squares Mean Binocular UCIVA (60cm) at Day 120-180 | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. 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 represents better visual acuity. | All-Implanted Analysis Set | Posted | Least Squares Mean | Standard Error | logMAR | Day 120-180 from second eye implantation |
|
|
|
|
| Secondary | Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180 | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. 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 represents better visual acuity. | All-Implanted Analysis Set | Posted | Least Squares Mean | Standard Error | logMAR | Day 120-180 from second eye implantation |
|
|
|
|
| Secondary | Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180 | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. 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 represents better visual acuity. | All-Implanted Analysis Set | Posted | Least Squares Mean | Standard Error | logMAR | Day 120-180 from second eye implantation |
|
|
|
|
| Secondary | Mean Photopic Binocular Defocus Curve at Day 120-180 | A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed. | This analysis population includes all subjects with eyes successfully implanted with the test or control article that had at least one postoperative visit, and with no macular degeneration at any time, and no major protocol deviations (Best-Case Analysis Set), with data available. | Posted | Mean | Standard Deviation | logMAR | Day 120-180 from second eye implantation |
|
|
|
| Secondary | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Best-Case Analysis Set, with available data | Posted | Mean | Standard Deviation | log units | Day 120-180 from second eye implantation |
|
|
|
| Secondary | Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Best-Case Analysis Set, with data available | Posted | Mean | Standard Deviation | log units | Day 120-180 from second eye implantation |
|
|
|
| Secondary | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Best-Case Analysis Set with data available | Posted | Mean | Standard Deviation | log units | Day 120-180 from second eye implantation |
|
|
|
| Secondary | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Best-Case Analysis Set, with data available | Posted | Mean | Standard Deviation | log units | Day 120-180 from second eye implantation |
|
|
|
| Secondary | Subject Satisfaction Recorded at Day 120-180 | At the Month 6 Visit, subjects responded to the question: "Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?". Responses were reported as a percentage of subjects. No statistical test was performed. | All-Implanted Analysis Set with data available | Posted | Number | percentage of subjects | Day 120-180 from second eye implantation |
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| 8 |
| 93 |
| EG001 | TFNT00 - 2nd Eye | Second eye implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL | 0 | 93 | 0 | 93 | 8 | 93 |
| EG002 | TFNT00 - Systemic | Subjects implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL in at least one eye | 0 | 93 | 2 | 93 | 0 | 93 |
| EG003 | 839MP - 1st Eye | First eye implanted with AT LISA® tri IOL | 0 | 89 | 3 | 89 | 7 | 89 |
| EG004 | 839MP - 2nd Eye | Second eye implanted with AT LISA® tri IOL | 0 | 87 | 2 | 87 | 3 | 87 |
| EG005 | 839MP - Non-Study Eye | Eyes not meeting study inclusion/exclusion criteria | 0 | 2 | 0 | 2 | 0 | 2 |
| EG006 | 839MP - Systemic | Subjects implanted with AT LISA® tri IOL in at least one eye | 0 | 89 | 0 | 89 | 0 | 89 |
| Cystoid macular oedema | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Device dislocation | Product Issues | MedDRA (19.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Intra-ocular injection | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| Intraocular lens implant | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Repeated Measures Analysis of Variance |
| 0.455 |
| Superiority |
| Repeated Measures Analysis of Variance |
| 0.003 |
| Superiority |
| -1.0D |
|
| -1.5D |
|
| -2.0D |
|
| -2.5D |
|
| -3.0D |
|
| -3.5D |
|
| -4.0D |
|
| -4.5D |
|
| -5.0D |
|
| 12 CPD |
|
| 18 CPD |
|
| 12 CPD |
|
| 18 CPD |
|
| 6 CPD |
|
| 12 CPD |
|
| 6 CPD |
|
| 12 CPD |
|
| Missing |
|