Visual Acuity After the Combined Binocular Implantation of +2.5 Diopters and +3.0 Diopters ReSTOR Multifocal Intraocular Lenses.

Study Overview
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Brief Summary
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The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.5 D and +3.0 D apodized diffractive multifocal intraocular lenses.

Detailed Description
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Bifocal multifocal intraocular lenses (MIOL) are effective in achieving good uncorrected visual acuities in the distance and the near. However, the intermediate vision is of increasing relevance for everyday's life. Several multifocal intraocular lenses have been developed to improvement intermediate vision. Nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. Therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses.

Official Title
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Evaluation of the Visual Acuity After the Implantation of a ReSTOR +2.5 Diopters Intraocular Lens (ReSTOR SV25T0) in the Distance Dominant Eye, in Combination With a +3.0 Diopters ReSTOR Intraocular Lens (ReSTOR SN6AD1) in the Fellow Eye.

Conditions
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Cataract

Intervention / Treatment
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* Device: Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically significant cataract endothelial cell count: patients aged 18-75 years: > 1000 cells/mm2; patients > 75 years: > 750 cells/mm2 absence of vision-limiting corneal or retinal comorbidities capability to understand the informed consent Exclusion Criteria: expected postoperative astigmatism > 0.75 diopters irregular astigmatism dilated pupil diameter < 3 mm corneal and fundus abnormalities that might cause visual impairments inability to attend follow-up visits

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-arm<br> | Device: Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses<br>* Binocular implantation of the combination of AcrySof® IQ ReSTOR® multifocal intraocular lenses with an addition of +2.5 D in the distance-dominant eye and +3.0 D in the fellow eye.<br>* Other names: AcrySof® IQ ReSTOR® multifocal intraocular lenses with an addition of +2.5 D (SV25-type) and +3.0 D (SN6A-type) are used.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuities in the far, intermediate and near | Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm). | 1 month | 
| Visual acuities in the far, intermediate and near | Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm). | 3 months | 
| Mesopic vision | Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare. | 1 month | 
| Mesopic vision | Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare. | 3 months | 
| Scotopic contrast sensitivity | Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare. | 1 month | 
| Scotopic contrast sensitivity | Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spectacle independence in the far, intermediate and near | Spectacle independence as stated by the patient. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multifocal Intraocular Lens, Binocular Trifocality, Cataract Surgery, Spectacle Independence, Intermediate Vision, Photopic Vision, Mesopic Vision, Scotopic Vision, Binocular Vision