Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

Study Overview
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Brief Summary
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The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.

Official Title
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Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

Conditions
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Cataract

Intervention / Treatment
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* Device: AcrySof® IQ IOL
* Device: Tecnis® Aspheric intraocular lens
* Device: Akreos® MI60 intraocular lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, aged 50 and over. Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens. Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation. Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively. Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions. Exclusion Criteria: Subjects who have previously had corneal surgery. Subjects who have potential visual acuity which is < 6/12 due to other ocular pathology Subjects with corneal pathology. Subjects with astigmatism of greater than 1D. Subjects diagnosed with glaucoma. Subjects diagnosed with diabetes. Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment Subjects with a know history of poor compliance Subjects with planned adjunctive surgery

Ages Eligible for Study
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Minimum Age: 50 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AcrySof® IQ intraocular lens | Device: AcrySof® IQ IOL<br>* Replacement of natural crystalline lens in cataract surgery<br>|
| Active Comparator: 2<br>Tecnis® Aspheric intraocular lens | Device: Tecnis® Aspheric intraocular lens<br>* Replacement of natural crystalline lens in cataract surgery<br>|
| Active Comparator: 3<br>Akreos® MI60 intraocular lens | Device: Akreos® MI60 intraocular lens<br>* Replacement of natural crystalline lens in cataract surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast sensitivity |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, intraocular lens