Clinical Evaluation of a New Aspheric Intraocular Lens.

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of a New Aspheric Intraocular Lens. A Prospective, Multi-Center, Comparative Study.

Conditions
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Cataract

Intervention / Treatment
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* Device: Advanced Akreos Adapt in one operated eye.
* Device: Akreos Adapt in fellow operated eye.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery. Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation, requiring a IOL power from 10 to 30 diopters. Exclusion Criteria: Patients with corneal damage. Patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated. Patients with any ocular pathology, other than the cataract, having repercussions on visual function:

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced Akreos Adapt<br>Advanced Akreos Adapt Aspheric Intraocular Lens (IOL). | Device: Advanced Akreos Adapt in one operated eye.<br>* Cataract surgery to implant the assigned IOL according to randomized schedule.<br>|
| Experimental: Akreos Adapt<br>Akreos Adapt Spherical Intraocular Lens (IOL). | Device: Akreos Adapt in fellow operated eye.<br>* Cataract surgery to implant the assigned IOL according to randomized schedule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |