Cataracts
Conditions
Keywords
Cataracts, Intraocular lens, Multifocal, Toric, Astigmatism, Presbyopia
Brief summary
The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Models SND1T3, SND1T4, SND1T5, and SND1T6 when implanted to replace the natural lens in Japanese cataract patients.
Detailed description
Eligible participants completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits: Day 1-2, Day 7-14, and Day 30-60 after each implantation, and Day 120-180 and Day 330-420 after second eye implantation. The second implantation occurred within 30 days of the first.The primary eye was defined as the eye with higher astigmatism, with the other eye defined as the secondary eye. If both eyes had the same level of astigmatism, the first implanted eye was set as the primary eye.
Interventions
Multifocal IOL with extended secondary focal point and astigmatism correction 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
* Sign informed consent; * Diagnosed with bilateral cataracts; * Planned cataract removal by phacoemulsification; * Potential postoperative visual acuity of 0.6 decimal or better in both eyes; * Preoperative astigmatism ≥ 0.75 diopter; * Clear intraocular media other than cataract in study eyes; * Calculated lens power and astigmatism within the available range; * Pupil size greater than or equal to 6 mm after dilation; * Able to undergo second eye surgery within 30 days of the first eye surgery; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Irregular corneal aberration as demonstrated by corneal topography; * Any inflammation or edema (swelling) of the cornea; * Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.6 decimal; * Diabetic retinopathy; * Previous refractive surgery, retinal detachment, corneal transplant; * Glaucoma; * Pregnant, nursing, or suspected of being pregnant; * Currently participating in another investigational drug or device study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Uncorrected Distance Decimal Visual Acuity | Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | Visual acuity (VA) was tested monocularly (each eye separately) unaided 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. |
| Monocular Uncorrected Near Decimal VA | Day 30-60, Day 120-180, Day 330-420 | VA was tested monocularly unaided at a distance of 40 centimeters (cm) 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. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 2 study sites located in Japan.
Pre-assignment details
This reporting group includes all implanted subjects (65).
Participants by arm
| Arm | Count |
|---|---|
| ReSTOR +3.0 AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | ReSTOR +3.0 |
|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 9.9 |
| Age, Customized 60-69 years | 24 participants |
| Age, Customized <60 years | 12 participants |
| Age, Customized 70-79 years | 25 participants |
| Age, Customized ≥ 80 years | 4 participants |
| Region of Enrollment Japan | 65 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 8 / 65 |
Outcome results
Primary
Monocular Uncorrected Distance Decimal Visual Acuity
Visual acuity (VA) was tested monocularly (each eye separately) unaided 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.
Time frame: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Day 1-2 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 0.5 to less than 0.7 decimal | 12 participants |
| Day 1-2 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye worse than 0.5 decimal | 3 participants |
| Day 1-2 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 1.0 decimal or better | 25 participants |
| Day 1-2 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 0.7 to less than 1.0 decimal | 29 participants |
| Day 1-2 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye worse than 0.5 decimal | 5 participants |
| Day 1-2 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 0.5 to less than 0.7 decimal | 14 participants |
| Day 1-2 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 0.7 to less than 1.0 decimal | 21 participants |
| Day 1-2 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 1.0 decimal or better | 21 participants |
| Day 7-14 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 1.0 decimal or better | 31 participants |
| Day 7-14 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 1.0 decimal or better | 35 participants |
| Day 7-14 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye worse than 0.5 decimal | 1 participants |
| Day 7-14 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 0.7 to less than 1.0 decimal | 22 participants |
| Day 7-14 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye worse than 0.5 decimal | 3 participants |
| Day 7-14 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 0.7 to less than 1.0 decimal | 27 participants |
| Day 7-14 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 0.5 to less than 0.7 decimal | 4 participants |
| Day 7-14 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 0.5 to less than 0.7 decimal | 7 participants |
| Day 30-60 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 0.5 to less than 0.7 decimal | 2 participants |
| Day 30-60 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 0.7 to less than 1.0 decimal | 28 participants |
| Day 30-60 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 1.0 decimal or better | 28 participants |
| Day 30-60 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 0.7 to less than 1.0 decimal | 30 participants |
| Day 30-60 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 0.5 to less than 0.7 decimal | 6 participants |
| Day 30-60 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye worse than 0.5 decimal | 3 participants |
| Day 30-60 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye worse than 0.5 decimal | 1 participants |
| Day 30-60 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 1.0 decimal or better | 32 participants |
| Day 120-180 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 0.7 to less than 1.0 decimal | 27 participants |
| Day 120-180 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 0.5 to less than 0.7 decimal | 3 participants |
| Day 120-180 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 0.7 to less than 1.0 decimal | 28 participants |
| Day 120-180 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye worse than 0.5 decimal | 0 participants |
| Day 120-180 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 1.0 decimal or better | 35 participants |
| Day 120-180 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye worse than 0.5 decimal | 1 participants |
| Day 120-180 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 0.5 to less than 0.7 decimal | 6 participants |
| Day 120-180 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 1.0 decimal or better | 30 participants |
| Day 330-420 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye worse than 0.5 decimal | 1 participants |
| Day 330-420 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 1.0 decimal or better | 32 participants |
| Day 330-420 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 0.5 to less than 0.7 decimal | 6 participants |
| Day 330-420 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye 0.7 to less than 1.0 decimal | 27 participants |
| Day 330-420 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 1.0 decimal or better | 31 participants |
| Day 330-420 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 0.5 to less than 0.7 decimal | 5 participants |
| Day 330-420 | Monocular Uncorrected Distance Decimal Visual Acuity | Secondary eye worse than 0.5 decimal | 0 participants |
| Day 330-420 | Monocular Uncorrected Distance Decimal Visual Acuity | Primary eye 0.7 to less than 1.0 decimal | 28 participants |
Primary
Monocular Uncorrected Near Decimal VA
VA was tested monocularly unaided at a distance of 40 centimeters (cm) 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.
Time frame: Day 30-60, Day 120-180, Day 330-420
Population: This analysis population includes all implanted subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Day 1-2 | Monocular Uncorrected Near Decimal VA | Primary eye worse than 0.4 decimal | 1 participants |
| Day 1-2 | Monocular Uncorrected Near Decimal VA | Primary eye 0.4 decimal or better | 64 participants |
| Day 1-2 | Monocular Uncorrected Near Decimal VA | Secondary eye worse than 0.4 decimal | 1 participants |
| Day 1-2 | Monocular Uncorrected Near Decimal VA | Secondary eye 0.4 decimal or better | 64 participants |
| Day 7-14 | Monocular Uncorrected Near Decimal VA | Secondary eye 0.4 decimal or better | 64 participants |
| Day 7-14 | Monocular Uncorrected Near Decimal VA | Primary eye worse than 0.4 decimal | 0 participants |
| Day 7-14 | Monocular Uncorrected Near Decimal VA | Secondary eye worse than 0.4 decimal | 1 participants |
| Day 7-14 | Monocular Uncorrected Near Decimal VA | Primary eye 0.4 decimal or better | 65 participants |
| Day 30-60 | Monocular Uncorrected Near Decimal VA | Secondary eye 0.4 decimal or better | 65 participants |
| Day 30-60 | Monocular Uncorrected Near Decimal VA | Primary eye 0.4 decimal or better | 64 participants |
| Day 30-60 | Monocular Uncorrected Near Decimal VA | Secondary eye worse than 0.4 decimal | 0 participants |
| Day 30-60 | Monocular Uncorrected Near Decimal VA | Primary eye worse than 0.4 decimal | 1 participants |