Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

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.

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Key information

Conditions

Visual Acuity

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Call Center

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RESTOR IOL Model SA60D3

Device

Implanted into the study eye following cataract extraction surgery

Primary outcomes

Near Uncorrected Visual Acuity(UCVA

Time frame: 6 months after surgery of 2nd eye

Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.

Secondary outcomes

Contrast Sensitivity

Time frame: 6 months after sugery of the 2nd eye

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Sep 25, 2008
Registry last updated: Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed