Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Alcon

Status: Completed

Conditions: Visual Acuity

Treatments: Device: RESTOR IOL Model SA60D3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759096

MS-06-03

Details and patient eligibility

About

The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.

Enrollment: 30 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥21 years of either gender or any race
• Potential post-op VA 20/20
• Pre-op astigmatism ≤ 1.0D
• Able to sign the informed consent
• Able to complete all required postoperative visits
• Planned cataract removal by phaco
• Clear intraocular media other than cataract

Exclusion criteria

• Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
• Any corneal pathology and previous corneal refractive surgery
• Patients with unrealistic expectations in anticipated post-op VA
• Happy to wear glasses
• Occupational night driver

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Acrysof ReSTOR IOL

Experimental group

Description:

AcrySof ReSTOR Intraocular lens (IOL) implanted

Treatment:

Device: RESTOR IOL Model SA60D3