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The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.
Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR +3 | Experimental | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation |
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| Acri.LISA | Active Comparator | Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 | Device | Multifocal IOL implanted for long-term use over the lifetime of the cataract patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Binocular Defocus VA at Month 3 | Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power 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 3 from second eye implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3 | Visual acuity (VA) was tested binocularly (both eyes together) 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. |
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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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Of the 31 enrolled participants, 1 exited prior to randomization due to withdrawn consent and 5 discontinued after randomization due to adverse event (1) and protocol deviation (4). This reporting group includes all randomized participants who received IOLs without major deviations and/or surgical complications (efficacy population).
Subjects were recruited from one investigative site located in Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | ReSTOR +3 | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation |
| FG001 | Acri.LISA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT | 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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| Acri.LISA® 366D IOL | Device | Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient |
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| Acri.LISA® 466TD Toric IOL | Device | Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient |
|
| Month 3 from second eye implantation |
| Uncorrected Visual Acuity Across a Range of Distances at Month 3 | VA was tested binocularly 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 3 from second eye implantation |
| Mean Refractive Spherical Equivalent at Month 3 | A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean. | Month 3 from second eye implantation |
| Mean Radner Reading Speed | Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute. | Month 3 from second eye implantation |
| Patient Reported Outcomes at Month 3 | The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated 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. | Month 3 from second eye implantation |
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation |
| COMPLETED |
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| NOT COMPLETED |
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This analysis population includes all randomized participants who received IOLs without major deviations and/or surgical complications (efficacy population).
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| ID | Title | Description |
|---|---|---|
| BG000 | ReSTOR +3 | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation |
| BG001 | Acri.LISA | Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, 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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| Region of Enrollment | Number | 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 | Mean Binocular Defocus VA at Month 3 | Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power 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 who received IOLs without major deviations and/or surgical complications. | Posted | Mean | Standard Deviation | logMAR | Month 3 from second eye implantation |
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| Secondary | Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3 | Visual acuity (VA) was tested binocularly (both eyes together) 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 who received IOLs without major deviations and/or surgical complications. | Posted | Mean | Standard Deviation | logMAR | Month 3 from second eye implantation |
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| Secondary | Uncorrected Visual Acuity Across a Range of Distances at Month 3 | VA was tested binocularly 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 who received IOLs without major deviations and/or surgical complications. | Posted | Mean | Standard Deviation | logMAR | Month 3 from second eye implantation |
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| Secondary | Mean Refractive Spherical Equivalent at Month 3 | A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean. | This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications. | Posted | Mean | Standard Deviation | diopter | Month 3 from second eye implantation |
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| Secondary | Mean Radner Reading Speed | Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute. | This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications. | Posted | Mean | Standard Deviation | wpm | Month 3 from second eye implantation |
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| Secondary | Patient Reported Outcomes at Month 3 | The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated 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 who received IOLs without major deviations and/or surgical complications. | Posted | Mean | Standard Deviation | units on a scale | Month 3 from second eye implantation |
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This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
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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 | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL | 2 | 17 | 10 | 17 | ||
| EG001 | Acri.LISA | Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL | 0 | 13 | 1 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular oedema | Eye disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Posterior capsule rupture | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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| Corneal oedema | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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| Corneal oedema/ocular hypertension | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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| Ocular hyperaemia/lacrimation | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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| Retinal cyst | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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| Intraocular pressure abnormal | Investigations | MedDRA (14.0) | 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 |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| Title | Measurements |
|---|---|
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| Male |
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| -4.00 diopter |
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| -3.50 diopter |
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| -3.00 diopter |
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| -2.50 diopter |
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| -2.00 diopter |
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| -1.50 diopter |
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| -1.00 diopter |
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| -0.50 diopter |
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| 0.00 diopter |
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| +0.50 diopter |
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| +1.00 diopter |
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| +1.50 diopter |
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| +2.00 diopter |
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| Participants |
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| OG003 | Acri.LISA/With | Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids |
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| Units | Counts |
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| Participants |
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