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Clinical Evaluation of a New Aspheric Intraocular Lens.

NCT ID: NCT00786565

Last Updated: 2011-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-01-31

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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Advanced Akreos Adapt

Advanced Akreos Adapt Aspheric Intraocular Lens (IOL).

Group Type EXPERIMENTAL

Advanced Akreos Adapt in one operated eye.

Intervention Type DEVICE

Cataract surgery to implant the assigned IOL according to randomized schedule.

Akreos Adapt

Akreos Adapt Spherical Intraocular Lens (IOL).

Group Type EXPERIMENTAL

Akreos Adapt in fellow operated eye.

Intervention Type DEVICE

Cataract surgery to implant the assigned IOL according to randomized schedule.

Interventions

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Advanced Akreos Adapt in one operated eye.

Cataract surgery to implant the assigned IOL according to randomized schedule.

Intervention Type DEVICE

Akreos Adapt in fellow operated eye.

Cataract surgery to implant the assigned IOL according to randomized schedule.

Intervention Type DEVICE

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:
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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001/04

Identifier Type: -

Identifier Source: org_study_id