Cataracts
Conditions
Keywords
Intraocular lens, Multifocal intraocular lens (MIOL)
Brief summary
The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral implantation) at Month 3 following the second eye surgery.
Detailed description
Each subject will complete a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Day 30 and Day 90 after the second implantation). The second implantation will occur between 1 and 45 days of the first. If the first eye is not implanted during surgery, the second eye is not eligible. lf both eyes are not implanted with the assigned IOL, the subject will be followed for safety evaluation.
Interventions
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to understand and sign informed consent, and attend postoperative examinations per protocol schedule; * Requires cataract extraction followed by posterior intraocular lens implantation used as an on-label procedure in both eyes; * Willing to have second eye surgery within 45 days of first eye surgery; * Expected postoperative astigmatism \< 1.0 D in both eyes, as measured by keratometry; * Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section of the package inserts; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Refractive lens exchange (monocular DCVA of worse than 20/20, or ≥ 0.06 logMAR). This exclusion did not apply to binocular (OU) measurement; * Significant irregular corneal astigmatism as demonstrated by corneal topography; * Severe degenerative visual disorders; * Previous corneal surgery; * Amblyopia; * Planned multiple procedures, including LRI, LASIK, etc, during surgery or the course of the study; * History of corneal disease; * Severe diabetic retinopathy; * History of retinal detachment; * Severe conditions or acute or chronic diseases or illnesses that, per investigator's clinical judgment, would increase the operative risk or confound the results of the study; * Pregnant or planning pregnancy during course of study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm) | Day 90 from second eye implantation | Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm) | Day 90 from second eye implantation | VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. |
Participant flow
Recruitment details
Subjects were recruited from 8 investigative sites located outside the USA, including Argentina (1), Chile (1), Germany (2), Netherlands (2), and Spain (2).
Pre-assignment details
Of the 112 subjects enrolled, 9 were discontinued prior to randomization as screen failures. This reporting group includes all implanted subjects (103).
Participants by arm
| Arm | Count |
|---|---|
| Bilateral AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation | 53 |
| Contralateral AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation | 50 |
| Total | 103 |
Baseline characteristics
| Characteristic | Bilateral | Total | Contralateral |
|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 7.9 | 66.6 years STANDARD_DEVIATION 9 | 65.9 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment Argentina | 7 participants | 14 participants | 7 participants |
| Region of Enrollment Chile | 10 participants | 19 participants | 9 participants |
| Region of Enrollment Germany | 13 participants | 26 participants | 13 participants |
| Region of Enrollment Netherlands | 12 participants | 21 participants | 9 participants |
| Region of Enrollment Spain | 11 participants | 23 participants | 12 participants |
| Sex: Female, Male Female | 35 Participants | 66 Participants | 31 Participants |
| Sex: Female, Male Male | 18 Participants | 37 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 53 | 3 / 50 |
| serious Total, serious adverse events | 0 / 53 | 2 / 50 |
Outcome results
Primary
Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)
Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
Time frame: Day 90 from second eye implantation
Population: This analysis population includes all subjects with both eyes implanted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral | Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm) | 0.13 logMAR | Standard Deviation 0.148 |
| Contralateral | Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm) | 0.09 logMAR | Standard Deviation 0.133 |
Secondary
Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)
VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
Time frame: Day 90 from second eye implantation
Population: This analysis population includes all subjects with both eyes implanted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral | Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm) | 0.26 logMAR | Standard Deviation 0.158 |
| Contralateral | Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm) | 0.10 logMAR | Standard Deviation 0.134 |