Cataract
Conditions
Brief summary
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.
Detailed description
This study will be conducted in regions where the test article is approved at the time of study start.
Interventions
Multifocal 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
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision; * Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures; * Clear intraocular media other than cataract in both eyes; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema; * Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies; * Glaucoma (uncontrolled or controlled with medication) or ocular hypertension; * Pregnant or lactating; * Expected to require ocular surgical or retinal laser treatment; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular Defocus Visual Acuity (VA) | Day 20-40 and Day 120-180 from second eye implantation | 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. |
Participant flow
Recruitment details
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).
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| TFNT00 AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation | 149 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 3 |
Baseline characteristics
| Characteristic | TFNT00 |
|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 9.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Sex: Female, Male Female | 92 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 149 | 0 / 148 | 0 / 1 | 3 / 149 |
| other Total, other adverse events | 21 / 149 | 21 / 148 | 0 / 1 | 0 / 149 |
| serious Total, serious adverse events | 3 / 149 | 4 / 148 | 0 / 1 | 11 / 149 |
Outcome results
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.
Time frame: Day 20-40 and Day 120-180 from second eye implantation
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | +1.50D | 0.404 logMAR | Standard Deviation 0.161 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | -0.50D | 0.037 logMAR | Standard Deviation 0.1099 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | -2.50D | 0.077 logMAR | Standard Deviation 0.1396 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | -3.00D | 0.148 logMAR | Standard Deviation 0.1417 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | -1.00D | 0.101 logMAR | Standard Deviation 0.1141 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | -3.50D | 0.257 logMAR | Standard Deviation 0.1532 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | +1.00D | 0.209 logMAR | Standard Deviation 0.1386 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | -4.00D | 0.387 logMAR | Standard Deviation 0.1624 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | -1.50D | 0.072 logMAR | Standard Deviation 0.1175 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | -4.50D | 0.495 logMAR | Standard Deviation 0.1674 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | 0.00D | -0.030 logMAR | Standard Deviation 0.1155 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | -5.00D | 0.621 logMAR | Standard Deviation 0.1597 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | -2.00D | 0.052 logMAR | Standard Deviation 0.127 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | +0.50D | 0.069 logMAR | Standard Deviation 0.1438 |
| TFNT00 Visit 3A | Mean Binocular Defocus Visual Acuity (VA) | +2.00 Diopter (D) | 0.570 logMAR | Standard Deviation 0.1893 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | -0.50D | 0.043 logMAR | Standard Deviation 0.118 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | +2.00 Diopter (D) | 0.569 logMAR | Standard Deviation 0.1844 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | +1.50D | 0.388 logMAR | Standard Deviation 0.1679 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | +1.00D | 0.214 logMAR | Standard Deviation 0.1413 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | +0.50D | 0.058 logMAR | Standard Deviation 0.1205 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | 0.00D | -0.037 logMAR | Standard Deviation 0.1069 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | -1.00D | 0.100 logMAR | Standard Deviation 0.1099 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | -1.50D | 0.065 logMAR | Standard Deviation 0.1302 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | -2.00D | 0.044 logMAR | Standard Deviation 0.1316 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | -2.50D | 0.066 logMAR | Standard Deviation 0.1338 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | -3.00D | 0.130 logMAR | Standard Deviation 0.1377 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | -3.50D | 0.256 logMAR | Standard Deviation 0.1551 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | -4.00D | 0.384 logMAR | Standard Deviation 0.153 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | -4.50D | 0.491 logMAR | Standard Deviation 0.1583 |
| TFNT00 Visit 4A | Mean Binocular Defocus Visual Acuity (VA) | -5.00D | 0.617 logMAR | Standard Deviation 0.1548 |