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The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.
This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR +3 | Experimental | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation |
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| ReSTOR +3 Toric | Experimental | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye |
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| Monofocal | Active Comparator | Monofocal IOL, bilateral implantation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL | Device | Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Classified as Responders | Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit. | Month 6 after second eye implantation |
| Proportion of Participants Reporting Spectacle Independence at All Distances | Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent. | Month 6 after second eye implantation |
| Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) | Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary. | Month 6 after second eye implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Median Total Spectacle Cost Prior to Any Reimbursement | Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros. | Month 6 after second eye implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brand Lead, Surgical, Global Medical Affairs | Alcon Research | Study Director |
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This reporting group includes all randomized participants, as randomized.
Participants were recruited from 20 investigative sites located in France (3), Germany (4), Great Britain (1), Italy (3), Netherlands (4), and Spain (5).
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| ID | Title | Description |
|---|---|---|
| FG000 | Multifocal IOL | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation |
| FG001 | Monofocal IOL | Monofocal IOL, bilateral implantation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL | Device | Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient |
|
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| Monofocal IOL | Device | Monofocal IOL implanted for long-term use over the lifetime of the cataract patient |
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| Implanted |
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| COMPLETED |
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| NOT COMPLETED |
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This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Multifocal IOL | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation |
| BG001 | Monofocal IOL | Monofocal IOL, bilateral implantation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Participants Classified as Responders | Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit. | This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized. Last observation carried forward (LOCF) was used for missing data. | Posted | Number | percentage of participants | Month 6 after second eye implantation |
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| Primary | Proportion of Participants Reporting Spectacle Independence at All Distances | Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent. | This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized. Last observation carried forward (LOCF) was used for missing data. | Posted | Number | percentage of participants | Month 6 after second eye implantation |
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| Primary | Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) | Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary. | This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Month 6 after second eye implantation |
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| Secondary | Median Total Spectacle Cost Prior to Any Reimbursement | Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros. | This analysis population includes all randomized and implanted participants. If total cost was missing for a spectacle independent subject, €0 was imputed. If total cost was missing for a spectacle-dependent subject, mean cost for all spectacle dependent-subjects in that group with a known total cost for the same type of spectacles was imputed. | Posted | Median | Inter-Quartile Range | euros | Month 6 after second eye implantation |
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An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device.
This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
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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 | Multifocal IOL | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation | 13 | 106 | 0 | 106 | ||
| EG001 | Monofocal IOL | Monofocal IOL, bilateral implantation | 9 | 100 | 0 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Astigmatism | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Corneal oedema | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Cystoid macular oedema | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Iridocele | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Lens dislocation | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Posterior capsular opacification | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Retinal tear | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Vitreous loss | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Vitritis | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Intestinal functional disorder | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Device material issue | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Endophthalmitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
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| Eye operation complication | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
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| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
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| Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Chronic pulmonary obstructive disease | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brand Lead, Surgical, Global Medical Affairs | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Title | Measurements |
|---|---|
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| 70 to 79 years |
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| ≥80 years |
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| Male |
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