Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)

NCT ID: NCT00759668

Last Updated: 2011-01-26

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

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-09-30

Brief Summary

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The purpose of the study is:

* to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
* to assess patient satisfaction before and after implant

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SN60D3

AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3

Group Type EXPERIMENTAL

Acrysof Natural ReSTOR SN60D3

Intervention Type DEVICE

Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.

SN60AT

AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT

Group Type ACTIVE_COMPARATOR

Acrysof Natural Monofocal SN60AT

Intervention Type DEVICE

Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.

Interventions

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Acrysof Natural ReSTOR SN60D3

Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.

Intervention Type DEVICE

Acrysof Natural Monofocal SN60AT

Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Age: ≥ 50 years ≤ 75 years
* Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)
* Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings
* Potential post operative Visual Acuity (VA) ≥ 20/40
* Second eye surgery to take place no longer than 45 days after the first implant

Exclusion:

* Irregular optical aberrations;
* Pupil diameter in scotopic conditions more than 6 mm
* Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))
* Other exclusions as from ReSTOR Directions for Use (DFU)
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Alcon

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IT 06 01

Identifier Type: -

Identifier Source: org_study_id

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