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The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.
This study will be conducted in regions where the test article is approved at the time of study start.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TFNT00 | Experimental | AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL | Device | Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Binocular Defocus Visual Acuity (VA) | Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The 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 visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned. | Day 20-40 and 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, Cataract | Alcon Research | Study Director |
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Of the 167 enrolled, 16 subjects were exited as screen failures prior to being implanted. An additional 2 subjects satisfied the eligibility criteria for the study, but were also discontinued prior to being implanted. This reporting group includes all implanted subjects (149).
Subjects were recruited from 17 study centers located in Australia (4), Chile (3), Germany (2), Italy (2), Spain (2), Belgium (1), Great Britain (1), France (1), and Netherlands (1).
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| ID | Title | Description |
|---|---|---|
| FG000 | TFNT00 | AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all implanted subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | TFNT00 | AcrySof® IQ PanOptix™ Presbyopia-Correcting 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 | Mean Binocular Defocus Visual Acuity (VA) | Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The 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 visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned. | This analysis population includes all eyes successfully implanted with the test article that had at least 1 postoperative visit, no previous surgery for correction of refractive errors, no preoperative ocular pathology or macular degeneration at any time, no pregnancy during the study, and no major protocol deviations (Best-Case Analysis Set). | Posted | Mean | Standard Deviation | logMAR | Day 20-40 and Day 120-180 from second eye implantation |
Test article implantation through study completion, an average of 1 year.
Adverse Events (AEs) were obtained through volunteered and elicited comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted test article implantation (successful or aborted after contact with the eye) (Safety Analysis Set). "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are 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 | All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 1st implanted eye |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA (18.0) | 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 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | TFNT00 Visit 3A | AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation at Day 20-40 post second eye implantation |
| OG001 | TFNT00 Visit 4A | AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation at Day 120-180 post second eye implantation |
|
|
| 0 |
| 149 |
| 3 |
| 149 |
| 21 |
| 149 |
| EG001 | TFNT00 - 2nd Eye | All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the 2nd implanted eye | 0 | 148 | 4 | 148 | 21 | 148 |
| EG002 | TFNT00 - Non-Study Eye | All eyes not implanted with a study lens | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | TFNT00 - Systemic | All subjects with attempted test article implantation (successful or aborted after contact with the eye). | 3 | 149 | 11 | 149 | 0 | 149 |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Optic nerve cup/disc ratio increased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Intraocular lens extraction | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Intraocular lens repositioning | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Retinopexy | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Vitrectomy | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.