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The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.
Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal IOL | Experimental | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation |
|
| Monofocal IOL | Active Comparator | AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] | Device | Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 | Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. 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 primary eye. | Day 120-180 from second eye implantation |
| Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL. | Day 0 first operative eye visit, up to Day 120-180 from second eye implantation |
| Photopic Contrast Sensitivity Without Glare at Day 120-180 | Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | Day 120-180 from second eye implantation |
| Photopic Contrast Sensitivity With Glare at Day 120-180 | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180 | VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. 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 primary eye. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magda Michna, PhD | Alcon Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32600261 | Derived | Williams JR, Kim HW, Crespi CM. Modeling observations with a detection limit using a truncated normal distribution with censoring. BMC Med Res Methodol. 2020 Jun 29;20(1):170. doi: 10.1186/s12874-020-01032-9. |
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Of the 409 participants enrolled, 80 were discontinued prior to randomization as screen failures and 9 were discontinued after randomization prior to implantation. This reporting group includes all participants with successful IOL implantation in at least 1 eye (320).
Participants were recruited and enrolled from 15 investigative sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multifocal IOL | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] |
| FG001 | Monofocal IOL | AcrySof® IQ Monofocal IOL Model SN60WF |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all participants with successful IOL implantation in at least 1 eye.
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| ID | Title | Description |
|---|---|---|
| BG000 | Multifocal IOL | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] |
| BG001 | Monofocal IOL | AcrySof® IQ Monofocal IOL Model SN60WF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 | Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. 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 primary eye. | This analysis population includes all participants with successful IOL implantation in the primary eye. | Posted | Mean | Standard Error | logMAR | Day 120-180 from second eye implantation | eyes | Participants |
|
Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012).
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Treatment | All enrolled participants |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid macular oedema (First Implanted Eye) | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Magda Michna, PhD | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| AcrySof® IQ Monofocal IOL Model SN60WF | Device | Monofocal IOL implanted for long-term use over the lifetime of the cataract patient |
|
| Day 120-180 from second eye implantation |
| Mesopic Contrast Sensitivity Without Glare at Day 120-180 | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | Day 120-180 from second eye implantation |
| Mesopic Contrast Sensitivity With Glare at Day 120-180 | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | Day 120-180 from second eye implantation |
| Day 120-180 from second eye implantation |
| Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180 | VA was tested monocularly (each eye separately) 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, 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 primary eye. | Day 120-180 from second eye implantation |
| Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses overall?" | Day 120-180 from second eye implantation |
| Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses for seeing objects up close?" | Day 120-180 from second eye implantation |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Monofocal IOL | AcrySof® IQ Monofocal IOL Model SN60WF |
|
|
| Primary | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL. | This analysis population includes all participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye). | Posted | Number | adverse events | Day 0 first operative eye visit, up to Day 120-180 from second eye implantation | eyes | Participants |
|
|
|
| Primary | Photopic Contrast Sensitivity Without Glare at Day 120-180 | Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis. | Posted | Mean | Standard Deviation | logMAR | Day 120-180 from second eye implantation |
|
|
|
| Secondary | Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180 | VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. 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 primary eye. | This analysis population includes all participants with successful IOL implantation in the primary eye. | Posted | Mean | Standard Error | logMAR | Day 120-180 from second eye implantation | eyes | Participants |
|
|
|
| Secondary | Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180 | VA was tested monocularly (each eye separately) 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, 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 primary eye. | This analysis population includes all participants with successful IOL implantation in the primary eye. | Posted | Mean | Standard Error | logMAR | Day 120-180 from second eye implantation | eyes | Participants |
|
|
|
| Secondary | Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses overall?" | This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present. | Posted | Number | participants | Day 120-180 from second eye implantation |
|
|
|
| Secondary | Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses for seeing objects up close?" | This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present. | Posted | Number | participants | Day 120-180 from second eye implantation |
|
|
|
| Primary | Photopic Contrast Sensitivity With Glare at Day 120-180 | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis. | Posted | Mean | Standard Deviation | logMAR | Day 120-180 from second eye implantation |
|
|
|
| Primary | Mesopic Contrast Sensitivity Without Glare at Day 120-180 | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis. | Posted | Mean | Standard Deviation | logMAR | Day 120-180 from second eye implantation |
|
|
|
| Primary | Mesopic Contrast Sensitivity With Glare at Day 120-180 | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis. | Posted | Mean | Standard Deviation | logMAR | Day 120-180 from second eye implantation |
|
|
|
| 1 |
| 409 |
| 0 |
| 409 |
| EG001 | Multifocal IOL | All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] | 10 | 155 | 0 | 155 |
| EG002 | Monofocal IOL | All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ Monofocal IOL Model SN60WF | 15 | 165 | 0 | 165 |
| Intraocular pressure increased (First Implanted Eye) | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Open angle glaucoma (First Implanted Eye) | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cataract operation complication (Second Implanted Eye) | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Cystoid macular oedema (Second Implanted Eye) | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device dislocation (Second Implanted Eye) | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eye operation (Second Implanted Eye) | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Intraocular injection (Second Implanted Eye) | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Intraocular pressure increased (Second Implanted Eye) | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Iritis (Second Implanted Eye) | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Open angle glaucoma (Second Implanted Eye) | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Retinal vein occlusion (Second Implanted Eye) | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Surgical procedure repeated (Second Implanted Eye) | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Wound complication (Second Implanted Eye) | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal mass | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry gangrene | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Extradural abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Incisional hernia gangrenous | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Measurements |
|---|---|
|
| Lens dislocated from posterior (cumulative) |
|
| Pupillary block (cumulative) |
|
| Retinal detachment (cumulative) |
|
| Secondary surgical intervention (cumulative) |
|
| Corneal stroma oedema (persistent) |
|
| Cystoid macular oedema (persistent |
|
| Iritis (persistent |
|
| Raised IOP requiring treatment (persistent) |
|
| 12 cpd (n=129,132) |
|
| 18 cpd (n=130,131) |
|
| Most of the time |
|
| All of the time |
|
| Most of the time |
|
| All of the time |
|
| 12 cpd (n=117,127) |
|
| 18 cpd (n=119,128) |
|
| 6 cpd (n=122,130) |
|
| 12 cpd (n=102,112) |
|
| 6 cpd (n=114,126) |
|
| 12 cpd (n=90,105) |
|