Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

This study has been completed.

Sponsor:

Information provided by:

Alcon Research

ClinicalTrials.gov Identifier:

NCT00759096

First received: September 23, 2008

Last updated: January 25, 2010

Last verified: January 2010

Results First Received: September 11, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Visual Acuity
Intervention:	Device: RESTOR IOL Model SA60D3

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible patients with bilateral cataract were implanted with ReSTOR lens and followed up for 6-month after the 2nd eye implantation

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open-label, single arm and nonrandomized

Reporting Groups

	Description
AcrySof ReSTOR IOL	Acrysof ReSTOR Intraocular Lens (IOL)

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
AcrySof ReSTOR IOL	Acrysof ReSTOR Intraocular Lens (IOL)

Baseline Measures

	AcrySof ReSTOR IOL
Number of Participants [units: participants]	30
Age [units: participants]
<=18 years	0
Between 18 and 65 years	3
>=65 years	27
Gender [units: participants]
Female	22
Male	8

Outcome Measures

1. Primary:

Near Uncorrected Visual Acuity(UCVA [ Time Frame: 6 months after surgery of 2nd eye ]

Show Outcome Measure 1

2. Secondary:

Contrast Sensitivity [ Time Frame: 6 months after sugery of the 2nd eye ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

Other Adverse Events

More Information