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This study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Akreos Adapt | Experimental | Advanced Akreos Adapt Aspheric Intraocular Lens (IOL). |
|
| Akreos Adapt | Experimental | Akreos Adapt Spherical Intraocular Lens (IOL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced Akreos Adapt in one operated eye. | Device | Cataract surgery to implant the assigned IOL according to randomized schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Low Contrast Best Corrected Visual Acuity Following Cataract Surgery | Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery. | 3 months |
| Low Contrast Uncorrected Visual Acuity Following Cataract Surgery | Low contrast uncorrected visual acuity 3 months post cataract surgery | 3 months |
| Photopic Contrast Sensitivity | The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd) | 3 months |
| Mesoptic Contrast Sensitivity | The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd) | 3 Months |
| Posterior Capsule Opacification Score | Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| High Contrast Visual Acuity | High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity. | 1 month |
| High Contrast Visual Acuity Uncorrected |
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Inclusion Criteria:
Exclusion Criteria:
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Planned enrollment was to consist of 120 subjects, due to difficulties in enrolling subjects within the designated 6 month enrollment window 75 subjects were entered into the study for a total of 150 treated eyes.
Recruitment began on 12/15/2004 and ended on 04/28/2006. This study was conducted at 5 European sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Akreos Intraocular Lens | Subjects randomised to receive Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment Prior to Surgery |
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| Post Surgery |
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| ID | Title | Description |
|---|---|---|
| BG000 | Akreos Intraocular Lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 69 participants (138 eyes)were randomised to receive Akreos Advanced Optic Aspheric Intraocular Lens in one eye (69 eyes) and Akreos Adapt Spherical Intraocular Lens in the fellow eye (69 eyes). |
| 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 | Low Contrast Best Corrected Visual Acuity Following Cataract Surgery | Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery. | Number of participants 67 total with 67 eyes in each group, full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy. | Posted | Mean | Standard Deviation | LogMAR | 3 months |
|
Ocular adverse events were measured over 24 month study period.
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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 | Akreos Advanced Intraocular Lenses | Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon Hayashida | Bausch & Lomb | (585) 338-6370 | jon.hayashida@bausch.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Akreos Adapt in fellow operated eye. | Device | Cataract surgery to implant the assigned IOL according to randomized schedule. |
|
| 3 months |
| High Contrast Visual Acuity Best Corrected | 3 months |
| High Contrast Visual Acuity | 12 months |
| High Contrast Visual Acuity Uncorrected | 24 Months |
| High Contrast Visual Acuity Best Corrected | 24 Months |
| Low Contrast Visual Acuity | Uncorrected Low contrast visual acuity - LogMar visual acuity value | 1 month |
| Contrast Sensitivity Photopic 1.5cpd | The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd) | 1 month |
| Contrast Sensitivity Photopic | The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd) | 1 month |
| Contrast Sensitivity Mesoptic 1.5 Cpd | The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd) | 1 month |
| Contrast Sensitivity Mesoptic | The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd) | 1 month |
| Posterior Capsule Opacification | Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification. | 12 months |
|
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Akreos Adapt Intraocular Lens
|
|
| Primary | Low Contrast Uncorrected Visual Acuity Following Cataract Surgery | Low contrast uncorrected visual acuity 3 months post cataract surgery | Full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy | Posted | Mean | Standard Deviation | LogMAR | 3 months |
|
|
|
| Primary | Photopic Contrast Sensitivity | The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd) | All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria. | Posted | Mean | Standard Deviation | Log 10 | 3 months |
|
|
|
| Secondary | High Contrast Visual Acuity | High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity. | Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control. | Posted | Mean | Standard Deviation | LogMAR | 1 month |
|
|
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| Secondary | High Contrast Visual Acuity Uncorrected | Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control. | Posted | Mean | Standard Deviation | LogMAR | 3 months |
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|
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| Secondary | High Contrast Visual Acuity Best Corrected | Patients without missing values for BHCVA logmar at pre-operative and post operative at 1 month control. | Posted | Mean | Standard Deviation | LogMAR | 3 months |
|
|
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| Secondary | High Contrast Visual Acuity | Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control. | Posted | Mean | Standard Deviation | LogMAR | 12 months |
|
|
|
| Primary | Mesoptic Contrast Sensitivity | The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd) | All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria. | Posted | Mean | Standard Deviation | Log 10 | 3 Months |
|
|
|
| Primary | Posterior Capsule Opacification Score | Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification. | The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area. | Posted | Mean | Standard Deviation | EPCO Score | 24 months |
|
|
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| Secondary | High Contrast Visual Acuity Uncorrected | Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control. | Posted | Mean | Standard Deviation | LogMar | 24 Months |
|
|
|
| Secondary | High Contrast Visual Acuity Best Corrected | Patients without missing values for best corrected HCVA logmar at pre-operative and post operative at 1 month control. | Posted | Mean | Standard Deviation | LogMar | 24 Months |
|
|
|
| Secondary | Low Contrast Visual Acuity | Uncorrected Low contrast visual acuity - LogMar visual acuity value | All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria. | Posted | Mean | Standard Deviation | LogMar | 1 month |
|
|
|
| Secondary | Contrast Sensitivity Photopic 1.5cpd | The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd) | All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria. | Posted | Mean | Standard Deviation | Log 10 | 1 month |
|
|
|
| Secondary | Contrast Sensitivity Photopic | The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd) | All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria. | Posted | Mean | Standard Deviation | Log 10 | 1 month |
|
|
|
| Secondary | Contrast Sensitivity Mesoptic 1.5 Cpd | The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd) | All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria. | Posted | Mean | Standard Deviation | Log 10 | 1 month |
|
|
|
| Secondary | Contrast Sensitivity Mesoptic | The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd) | All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria. | Posted | Mean | Standard Deviation | Log 10 | 1 month |
|
|
|
| Secondary | Posterior Capsule Opacification | Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification. | The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area. | Posted | Mean | Standard Deviation | EPCO Score | 12 months |
|
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | Akreos Adapt Intraocular Lens | Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye. | 0 | 69 | 0 | 69 |
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| Photopic Contrast Sensitivity - 6.0 |
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| Photopic Contrast Sensitivity - 12.0 |
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| Photopic Contrast Sensitivity - 18.0 |
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| Mesopic Contrast Sensitivity - 6.0 |
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| Mesopic Contrast Sensitivity - 12.0 |
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| Mesopic Contrast Sensitivity - 18.0 |
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| Photopic contrast sensitivity - 12.0 |
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| Photopic contrast sensitivity - 18.0 |
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| Mesoptic contrast sensitivity - 12.0 |
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| Mesoptic contrast sensitivity - 18.0 |
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