Cataracts
Conditions
Keywords
Cataract surgery, Intraocular lens
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of an investigational multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.
Detailed description
Participants 21 years and older within the targeted astigmatism range and in need of cataract extraction in both eyes were consented and randomized in a 2:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® Multifocal Toric IOL or the control AcrySof® ReSTOR® Multifocal IOL in both eyes. Each participant completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60 and binocular testing at Day 120-180 and Day 340-420/Visit 5 following the second implantation. The eye with the greater amount of astigmatism was implanted first (first operative eye). The second eye implant was intended to occur within 30 days after the first eye implant but not prior to 7 days after the first eye implant. Both eyes needed to qualify under inclusion/exclusion criteria at the preoperative visit. If the first eye was excluded during surgery, the second eye was not eligible. If the second eye was excluded during surgery, only the first eye was followed.
Interventions
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
DEVICEAcrySof® ReSTOR® Multifocal IOL Model SA60D3
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with bilateral cataracts; * Able to comprehend and sign a statement of informed consent; * Calculated lens power and astigmatism within the available range; * Willing and able to complete all required postoperative visits; * Planned cataract removal by phacoemulsification; * Potential postoperative visual acuity of 0.2 logMAR or better in both eyes; * Preoperative astigmatism in both operative eyes as described in the clinical protocol; Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study. * Clear intraocular media other than cataract in study eyes; * Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR in each eye; * 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-specified inclusion criteria may apply.
Exclusion criteria
* Significant irregular corneal aberration as demonstrated by corneal topography; * Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism; * Any inflammation or edema (swelling) of the cornea; * Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.2 logMAR; * Reasonably expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy); * Previous corneal refractive surgery; * Amblyopia; * Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy); * Diabetic retinopathy; * Extremely shallow anterior chamber, not due to swollen cataract; * Microphthalmos; * Previous retinal detachment; * Previous corneal transplant; * Recurrent severe anterior or posterior segment inflammation of unknown etiology; * Rubella or traumatic cataract; * Iris neovascularization; * Glaucoma (uncontrolled or controlled with medication); * Aniridia; * Optic nerve atrophy; * Pregnancy; * Current participation in another investigational drug or device study that may confound the results of this investigation; * Other planned ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions, for the duration of the study; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5 | Month 12 from second eye implantation | Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye. |
| Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5 | Month 12 from second eye implantation | VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. VA was measured in 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. This analysis was prespecified for the first operative eye. |
| Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5 | Month 12 from second eye implantation | The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn't actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Month 12 from second eye implantation | Visual disturbances/distortions were reported by the participant on the Assessment of Photic Phenomena and Lens EffectS (APPLES) questionnaire, a Patient Reported Outcome (PRO) questionnaire intended to evaluate 10 distinct visual phenomena associated with cataract extraction and IOL implantation. The first 20 questions addressed both the frequency and severity of the phenomena using a 4-point categorical scale ranging from never to always (frequency) or none to severe (severity). The final (21st) question indicated whether the participant answered the questions based on experiences with or without glasses. The participant completed the assessment as a retrospective analysis of the previous week. Rate is presented as the percentage of participants with severity score severe for the visual phenomenon. |
Participant flow
Recruitment details
Participants were recruited from 21 investigative sites located in the United States.
Pre-assignment details
Of the 677 participants enrolled, 103 were exited prior to randomization as screen failures. This reporting population includes all participants with successful IOL implantation in at least 1 eye (574).
Participants by arm
| Arm | Count |
|---|---|
| ReSTOR Toric IOL AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation | 386 |
| ReSTOR IOL AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation | 188 |
| Total | 574 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 3 | 1 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Subject moved | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | ReSTOR Toric IOL | Total | ReSTOR IOL |
|---|---|---|---|
| Age, Continuous | 66.91 years STANDARD_DEVIATION 9.2 | 67.38 years STANDARD_DEVIATION 8.88 | 68.36 years STANDARD_DEVIATION 8.13 |
| Sex: Female, Male Female | 240 Participants | 376 Participants | 136 Participants |
| Sex: Female, Male Male | 146 Participants | 198 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 48 / 386 | 28 / 188 |
| serious Total, serious adverse events | 45 / 386 | 21 / 188 |
Outcome results
Primary
Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5
Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time frame: Month 12 from second eye implantation
Population: This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric IOL | Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5 | 0.126 logMAR | Standard Error 0.013 |
| ReSTOR IOL | Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5 | 0.125 logMAR | Standard Error 0.015 |
Primary
Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5
VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. VA was measured in 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. This analysis was prespecified for the first operative eye.
Time frame: Month 12 from second eye implantation
Population: This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReSTOR Toric IOL | Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5 | 0.19 logMAR | Standard Deviation 0.015 |
| ReSTOR IOL | Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5 | 0.24 logMAR | Standard Deviation 0.017 |
Primary
Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5
The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn't actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.
Time frame: Month 12 from second eye implantation
Population: This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). For participants with actual SSIs, performance testing outcomes conducted prior to the secondary intervention were carried forward to the final analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ReSTOR Toric IOL | Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5 | First Implanted Eye | 1.04 percentage of participants |
| ReSTOR Toric IOL | Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5 | Second Implanted Eye | 0.52 percentage of participants |
| ReSTOR IOL | Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5 | Second Implanted Eye | 2.13 percentage of participants |
| ReSTOR IOL | Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5 | First Implanted Eye | 2.13 percentage of participants |
Secondary
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Visual disturbances/distortions were reported by the participant on the Assessment of Photic Phenomena and Lens EffectS (APPLES) questionnaire, a Patient Reported Outcome (PRO) questionnaire intended to evaluate 10 distinct visual phenomena associated with cataract extraction and IOL implantation. The first 20 questions addressed both the frequency and severity of the phenomena using a 4-point categorical scale ranging from never to always (frequency) or none to severe (severity). The final (21st) question indicated whether the participant answered the questions based on experiences with or without glasses. The participant completed the assessment as a retrospective analysis of the previous week. Rate is presented as the percentage of participants with severity score severe for the visual phenomenon.
Time frame: Month 12 from second eye implantation
Population: This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ReSTOR Toric IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Blurred vision | 0.8 percentage of participants |
| ReSTOR Toric IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Color distortion | 0.0 percentage of participants |
| ReSTOR Toric IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Flat lines look curved | 0.0 percentage of participants |
| ReSTOR Toric IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Straight lines look tilted | 0.0 percentage of participants |
| ReSTOR Toric IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Double vision | 0.8 percentage of participants |
| ReSTOR Toric IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Feeling sick due to visual distortion | 0.0 percentage of participants |
| ReSTOR Toric IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Glare | 3.5 percentage of participants |
| ReSTOR Toric IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Halos | 7.5 percentage of participants |
| ReSTOR Toric IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Hazy vision | 1.3 percentage of participants |
| ReSTOR Toric IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Starbursts | 4.3 percentage of participants |
| ReSTOR IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Halos | 11.0 percentage of participants |
| ReSTOR IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Blurred vision | 0.0 percentage of participants |
| ReSTOR IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Feeling sick due to visual distortion | 0.5 percentage of participants |
| ReSTOR IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Color distortion | 0.0 percentage of participants |
| ReSTOR IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Starbursts | 8.8 percentage of participants |
| ReSTOR IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Flat lines look curved | 0.0 percentage of participants |
| ReSTOR IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Glare | 2.7 percentage of participants |
| ReSTOR IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Straight lines look tilted | 0.0 percentage of participants |
| ReSTOR IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Hazy vision | 0.5 percentage of participants |
| ReSTOR IOL | Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 | Double vision | 0.0 percentage of participants |