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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR +3.0 | Experimental | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 from second eye implantation |
| 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. | Month 6 from second eye implantation |
| 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. | Month 6 from second eye implantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 population includes all enrolled subjects.
Subjects were recruited from 5 investigational sites located in Germany (2), Venezuela (2), and Spain (1).
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| ID | Title | Description |
|---|---|---|
| FG000 | ReSTOR +3.0 Toric | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
This analysis population includes all patients receiving IOL implantation in both eyes that completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | ReSTOR +3.0 Toric | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation |
| 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 | 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. | This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. | Posted | Mean | Standard Deviation | logMAR | Month 6 from second eye implantation |
|
An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship.
This analysis population includes all enrolled subjects that underwent surgery independent of IOL implantation.
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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 | ReSTOR +3.0 Toric | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular oedema | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule opacification | Eye disorders | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brand Lead, Surgical, Global Medical Affairs | 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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|
| Month 6 from second eye implantation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. | Posted | Mean | Standard Deviation | logMAR | Month 6 from second eye implantation |
|
|
|
| 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. | This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. | Posted | Number | percentage of participants | Month 6 from second eye implantation |
|
|
|
| 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. | This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. A subject may have responded with and without. | Posted | Mean | Standard Deviation | units on a scale | Month 6 from second eye implantation |
|
|
|
| 7 |
| 49 |
| 3 |
| 49 |
| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Intraocular pressure test abnormal | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Intraocular Lens Repositioning | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Measurements |
|---|---|
|
| Intermediate 50 cm |
|
| Near 40 cm |
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| Near - preferred distance |
|
| Title | Measurements |
|---|
|
| Intermediate function scale score |
|
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| Extended intermediate function scale score |
|
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