Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.
Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PanOptix IOL | Experimental | AcrySof® IQ PanOptix™ IOL, bilateral implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® IQ PanOptix™ IOL | Device | Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study. | Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation |
| Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study. | Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation |
| Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study. | Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Group Manager, Clinical Development | Alcon Japan, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Fukuoka | 812-0011 | Japan | |||
| Alcon Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 76 enrolled, 8 subjects were exited as screen failures prior to implantation. This reporting group includes all implanted subjects (68).
Subjects were recruited from 2 investigative sites located in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TFNT00 | AcrySof® IQ PanOptix™ IOL, bilateral implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all eyes with successful test article implantation (All-Implanted Analysis Set)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TFNT00 | AcrySof® IQ PanOptix™ 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 | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study. | All-Implanted Analysis Set | Posted | Number | subjects | Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation | Eyes | Eyes |
|
IOL implantation through study completion, an average of 6 months
An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of whether or not the event has a causal relationship with the medical device(s) or test procedure(s) in the study. Safety was assessed at each visit. This analysis population includes all eyes with attempted implantation (successful or aborted after contact with the eye) (Safety Analysis Set).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TFNT00 | All subjects implanted with AcrySof® IQ PanOptix™ IOL | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Expert Clinical Project Lead, CDMA Surgical | Alcon Research | 1-888-451-3937 | alcon.medinfo@alcon.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 23, 2017 | Apr 10, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2017 | Apr 10, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tokyo |
| 101-0061 |
| Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
AcrySof® IQ PanOptix™ IOL, second eye implantation |
|
|
| Primary | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study. | All-Implanted Analysis Set | Posted | Number | subjects | Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation | Eyes | Eyes |
|
|
|
| Primary | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study. | All-Implanted Analysis Set | Posted | Number | subjects | Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation | Eyes | Eyes |
|
|
|
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Visit 0 preoperative: 0.7 - < 1.0 |
|
| Visit 0 preoperative: 1.0 or better |
|
| Visit 1/1A: < 0.5 |
|
| Visit 1/1A: 0.5 - < 0.7 |
|
| Visit 1/1A: 0.7 - < 1.0 |
|
| Visit 1/1A: 1.0 or better |
|
| Visit 2/2A: < 0.5 |
|
| Visit 2/2A: 0.5 - < 0.7 |
|
| Visit 2/2A: 0.7 - < 1.0 |
|
| Visit 2/2A: 1.0 or better |
|
| Visit 3/3A: < 0.5 |
|
| Visit 3/3A: 0.5 - < 0.7 |
|
| Visit 3/3A: 0.7 - < 1.0 |
|
| Visit 3/3A: 1.0 or better |
|
| Visit 4A: < 0.5 |
|
| Visit 4A: 0.5 - < 0.7 |
|
| Visit 4A: 0.7 - < 1.0 |
|
| Visit 4A: 1.0 or better |
|
| Visit 1/1A: < 0.4 |
|
| Visit 1/1A: 0.4 or better |
|
| Visit 2/2A: < 0.4 |
|
| Visit 2/2A: 0.4 or better |
|
| Visit 3/3A: < 0.4 |
|
| Visit 3/3A: 0.4 or better |
|
| Visit 4A: < 0.4 |
|
| Visit 4A: 0.4 or better |
|