Cataract
Conditions
Keywords
Trifocal IOL
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAcrySof® IQ PanOptix™ IOL
Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
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
* Able to comprehend and sign a statement of informed consent; * Willing and able to complete all required postoperative visits; * Cataracts in both eyes with planned cataract removal by phacoemulsification; * Calculated lens power within the available range; * Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes; * Able to undergo second eye surgery within 30 days of the first eye surgery.
Exclusion criteria
* Significant irregular corneal aberration as demonstrated by corneal topography; * Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity; * Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses; * Previous refractive surgery; * Diabetic retinopathy * Other eye conditions as specified in the protocol * Pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | 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 | 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. |
| Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | 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 | 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. |
| Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | 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 | 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. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 2 investigative sites located in Japan.
Pre-assignment details
Of the 76 enrolled, 8 subjects were exited as screen failures prior to implantation. This reporting group includes all implanted subjects (68).
Participants by arm
| Arm | Count |
|---|---|
| TFNT00 AcrySof® IQ PanOptix™ IOL, bilateral implantation | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | TFNT00 | — |
|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 7.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 49 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 68 |
| other Total, other adverse events | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
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.
Time frame: 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
Population: All-Implanted Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 0 preoperative: < 0.5 | 15 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 0 preoperative: 0.5 - < 0.7 | 9 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 0 preoperative: 0.7 - < 1.0 | 35 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 0 preoperative: 1.0 or better | 9 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 1/1A: < 0.5 | 0 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 1/1A: 0.5 - < 0.7 | 1 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 1/1A: 0.7 - < 1.0 | 8 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 1/1A: 1.0 or better | 59 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 2/2A: < 0.5 | 0 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 2/2A: 0.5 - < 0.7 | 0 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 2/2A: 0.7 - < 1.0 | 0 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 2/2A: 1.0 or better | 68 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 3/3A: < 0.5 | 0 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 3/3A: 0.5 - < 0.7 | 0 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 3/3A: 0.7 - < 1.0 | 2 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 3/3A: 1.0 or better | 66 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 4A: < 0.5 | 0 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 4A: 0.5 - < 0.7 | 0 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 4A: 0.7 - < 1.0 | 2 subjects |
| First Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 4A: 1.0 or better | 66 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 4A: 0.5 - < 0.7 | 0 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 0 preoperative: < 0.5 | 5 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 2/2A: 0.7 - < 1.0 | 0 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 0 preoperative: 0.5 - < 0.7 | 8 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 3/3A: 1.0 or better | 66 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 0 preoperative: 0.7 - < 1.0 | 34 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 2/2A: 1.0 or better | 67 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 0 preoperative: 1.0 or better | 20 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 4A: 1.0 or better | 65 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 1/1A: < 0.5 | 0 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 3/3A: < 0.5 | 0 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 1/1A: 0.5 - < 0.7 | 0 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 4A: < 0.5 | 0 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 1/1A: 0.7 - < 1.0 | 8 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 3/3A: 0.5 - < 0.7 | 0 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 1/1A: 1.0 or better | 59 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 4A: 0.7 - < 1.0 | 2 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 2/2A: < 0.5 | 0 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 3/3A: 0.7 - < 1.0 | 1 subjects |
| Second Eye | Monocular Photopic Best Corrected Distance Visual Acuity (5 m) | Visit 2/2A: 0.5 - < 0.7 | 0 subjects |
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.
Time frame: 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
Population: All-Implanted Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 0 preoperative: < 0.5 | 47 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 0 preoperative: 0.5 - < 0.7 | 18 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 0 preoperative: 0.7 - < 1.0 | 1 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 0 preoperative: 1.0 or better | 2 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 1/1A: < 0.5 | 2 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 1/1A: 0.5 - < 0.7 | 8 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 1/1A: 0.7 - < 1.0 | 21 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 1/1A: 1.0 or better | 37 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 2/2A: < 0.5 | 0 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 2/2A: 0.5 - < 0.7 | 1 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 2/2A: 0.7 - < 1.0 | 13 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 2/2A: 1.0 or better | 54 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 3/3A: < 0.5 | 0 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 3/3A: 0.5 - < 0.7 | 5 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 3/3A: 0.7 - < 1.0 | 5 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 3/3A: 1.0 or better | 58 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 4A: < 0.5 | 2 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 4A: 0.5 - < 0.7 | 3 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 4A: 0.7 - < 1.0 | 4 subjects |
| First Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 4A: 1.0 or better | 59 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 4A: 0.5 - < 0.7 | 3 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 0 preoperative: < 0.5 | 40 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 2/2A: 0.7 - < 1.0 | 7 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 0 preoperative: 0.5 - < 0.7 | 18 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 3/3A: 1.0 or better | 58 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 0 preoperative: 0.7 - < 1.0 | 8 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 2/2A: 1.0 or better | 60 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 0 preoperative: 1.0 or better | 1 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 4A: 1.0 or better | 56 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 1/1A: < 0.5 | 1 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 3/3A: < 0.5 | 0 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 1/1A: 0.5 - < 0.7 | 5 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 4A: < 0.5 | 1 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 1/1A: 0.7 - < 1.0 | 25 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 3/3A: 0.5 - < 0.7 | 1 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 1/1A: 1.0 or better | 36 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 4A: 0.7 - < 1.0 | 7 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 2/2A: < 0.5 | 0 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 3/3A: 0.7 - < 1.0 | 8 subjects |
| Second Eye | Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) | Visit 2/2A: 0.5 - < 0.7 | 0 subjects |
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.
Time frame: 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
Population: All-Implanted Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 1/1A: < 0.4 | 1 subjects |
| First Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 2/2A: 0.4 or better | 68 subjects |
| First Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 0 preoperative: 0.4 or better | 20 subjects |
| First Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 3/3A: < 0.4 | 0 subjects |
| First Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 3/3A: 0.4 or better | 68 subjects |
| First Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 1/1A: 0.4 or better | 67 subjects |
| First Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 4A: < 0.4 | 2 subjects |
| First Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 0 preoperative: < 0.4 | 48 subjects |
| First Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 4A: 0.4 or better | 66 subjects |
| First Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 2/2A: < 0.4 | 0 subjects |
| Second Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 4A: 0.4 or better | 66 subjects |
| Second Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 0 preoperative: < 0.4 | 40 subjects |
| Second Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 0 preoperative: 0.4 or better | 27 subjects |
| Second Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 1/1A: < 0.4 | 0 subjects |
| Second Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 1/1A: 0.4 or better | 67 subjects |
| Second Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 2/2A: < 0.4 | 0 subjects |
| Second Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 2/2A: 0.4 or better | 67 subjects |
| Second Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 3/3A: 0.4 or better | 67 subjects |
| Second Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 4A: < 0.4 | 1 subjects |
| Second Eye | Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) | Visit 3/3A: < 0.4 | 0 subjects |