Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

November 13, 2023 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Alcon Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acrysof ReSTOR IOL
AcrySof ReSTOR Intraocular lens (IOL) implanted
Device: RESTOR IOL Model SA60D3
Implanted into the study eye following cataract extraction surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after surgery of 2nd eye

Secondary Outcome Measures

Outcome Measure
Time Frame
Contrast Sensitivity
Time Frame: 6 months after sugery of the 2nd eye
6 months after sugery of the 2nd eye

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 23, 2008

First Posted (Estimated)

September 25, 2008

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MS-06-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Visual Acuity

Clinical Trials on RESTOR IOL Model SA60D3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe