Cataract
Conditions
Keywords
intraocular lens, multifocal, toric
Brief summary
The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.
Detailed description
Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.
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
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Sign informed consent; * Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes; * Able to undergo second eye surgery within one month (30 days) of first eye surgery; * Able to attend postoperative examinations per protocol schedule; * Qualify for a AcrySof IQ Toric IOL in both eyes; * Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes; * Residual refractive cylinder of ≤0.5 D in both eyes; * Good ocular health; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Planned multiple procedures, including LRI, during cataract/IOL implantation surgery; * Amblyopia; * Previous corneal surgery; * Clinically significant corneal endothelial dystrophy; * History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.); * History of retinal detachment; * Pregnant or planning to become pregnant during course of study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Visual Acuity Across a Range of Distances at Month 6 | Month 6 from second eye implantation | Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA 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 ETDRS chart. A lower numeric value represents better visual acuity. |
| Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 | Month 6 from second eye implantation | VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA 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 ETDRS chart. A lower numeric value represents better visual acuity. |
| Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6 | Month 6 from second eye implantation | Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes at Month 6 | Month 6 from second eye implantation | The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m. |
Participant flow
Recruitment details
Subjects were recruited from 5 investigational sites located in Germany (2), Venezuela (2), and Spain (1).
Pre-assignment details
This reporting population includes all enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| ReSTOR +3.0 Toric AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | ReSTOR +3.0 Toric |
|---|---|
| Age, Continuous | 62.52 years STANDARD_DEVIATION 7.49 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 49 |
| serious Total, serious adverse events | 7 / 49 |
Outcome results
Primary
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6
VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA 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 ETDRS chart. A lower numeric value represents better visual acuity.
Time frame: Month 6 from second eye implantation
Population: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR +3.0 Toric | Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 | Intermediate 50 cm | 0.06 logMAR | Standard Deviation 0.1 |
| ReSTOR +3.0 Toric | Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 | Far distance 4 m | 0.00 logMAR | Standard Deviation 0.06 |
| ReSTOR +3.0 Toric | Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 | Intermediate 70 cm | 0.19 logMAR | Standard Deviation 0.14 |
| ReSTOR +3.0 Toric | Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 | Intermediate 60 cm | 0.14 logMAR | Standard Deviation 0.14 |
| ReSTOR +3.0 Toric | Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 | Near 40 cm | 0.04 logMAR | Standard Deviation 0.07 |
| ReSTOR +3.0 Toric | Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 | Near - preferred distance | 0.05 logMAR | Standard Deviation 0.08 |
Primary
Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6
Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.
Time frame: Month 6 from second eye implantation
Population: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ReSTOR +3.0 Toric | Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6 | ± 0.5D | 84.5 percentage of participants |
| ReSTOR +3.0 Toric | Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6 | ± 0.75D | 92.9 percentage of participants |
| ReSTOR +3.0 Toric | Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6 | ±1.0D | 95.2 percentage of participants |
Primary
Uncorrected Visual Acuity Across a Range of Distances at Month 6
Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA 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 ETDRS chart. A lower numeric value represents better visual acuity.
Time frame: Month 6 from second eye implantation
Population: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR +3.0 Toric | Uncorrected Visual Acuity Across a Range of Distances at Month 6 | Intermediate 60 cm | 0.09 logMAR | Standard Deviation 0.11 |
| ReSTOR +3.0 Toric | Uncorrected Visual Acuity Across a Range of Distances at Month 6 | Intermediate 50 cm | 0.05 logMAR | Standard Deviation 0.09 |
| ReSTOR +3.0 Toric | Uncorrected Visual Acuity Across a Range of Distances at Month 6 | Near 40 cm | 0.07 logMAR | Standard Deviation 0.09 |
| ReSTOR +3.0 Toric | Uncorrected Visual Acuity Across a Range of Distances at Month 6 | Near - preferred | 0.04 logMAR | Standard Deviation 0.08 |
| ReSTOR +3.0 Toric | Uncorrected Visual Acuity Across a Range of Distances at Month 6 | Far distance 4 meters (m) | 0.05 logMAR | Standard Deviation 0.1 |
| ReSTOR +3.0 Toric | Uncorrected Visual Acuity Across a Range of Distances at Month 6 | Intermediate 70 centimeters (cm) | 0.15 logMAR | Standard Deviation 0.13 |
Secondary
Patient Reported Outcomes at Month 6
The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.
Time frame: Month 6 from second eye implantation
Population: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. A subject may have responded with and without.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR +3.0 Toric | Patient Reported Outcomes at Month 6 | Near function scale score | 1.72 units on a scale | Standard Deviation 0.65 |
| ReSTOR +3.0 Toric | Patient Reported Outcomes at Month 6 | Intermediate function scale score | 1.49 units on a scale | Standard Deviation 0.59 |
| ReSTOR +3.0 Toric | Patient Reported Outcomes at Month 6 | Extended intermediate function scale score | 1.24 units on a scale | Standard Deviation 0.38 |
| ReSTOR +3.0 Toric/With | Patient Reported Outcomes at Month 6 | Near function scale score | 1.65 units on a scale | Standard Deviation 0.6 |
| ReSTOR +3.0 Toric/With | Patient Reported Outcomes at Month 6 | Intermediate function scale score | 1.21 units on a scale | Standard Deviation 0.51 |
| ReSTOR +3.0 Toric/With | Patient Reported Outcomes at Month 6 | Extended intermediate function scale score | 1.20 units on a scale | Standard Deviation 0.37 |