Cataract
Conditions
Keywords
Intraocular Lens, Toric
Brief summary
The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.
Interventions
DEVICEIQ SN60WF
Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient
DEVICEToric T3 - T9
Commercially available, acrylic, multifocal IOL intended to provide visual correction 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 an informed consent; * Willing and able to attend post-operative examinations per protocol schedule; * In good ocular health, with the exception of cataracts; * Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens; * Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry; * In good ocular health, with the exception of cataracts; * Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Previous corneal surgery; * Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures; * Planned multiple procedures during cataract/IOL implantation surgery; * Ocular disease and/or condition that may compromise study results; * Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment; * Pregnant or planning pregnancy during course of study; * Participation in any other investigational study within 30 days prior to enrolment; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 | Month 3 | Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity. |
Participant flow
Recruitment details
Subjects were recruited from one study center located in Russia.
Participants by arm
| Arm | Count |
|---|---|
| Toric T3 - T9 AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye. | 12 |
| IQ SN60WF AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Toric T3 - T9 | IQ SN60WF | Total |
|---|---|---|---|
| Age Continuous | 48.2 years STANDARD_DEVIATION 18.64 | 55.5 years STANDARD_DEVIATION 16.52 | 51.8 years STANDARD_DEVIATION 17.63 |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 1 / 12 | 0 / 12 |
Outcome results
Primary
Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3
Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.
Time frame: Month 3
Population: Per protocol: All subjects who received IOLs in both eyes and followed the protocol with no major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toric T3 - T9 | Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 | 0.089 logMAR | Standard Deviation 0.1212 |
| IQ SN60WF | Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 | 0.225 logMAR | Standard Deviation 0.1503 |