Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00759096
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: RESTOR IOL Model SA60D3	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jul 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Near Uncorrected Visual Acuity(UCVA [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 Outcome Measures

1. Contrast Sensitivity [6 months after sugery of the 2nd eye]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00759096
• Other Study ID Numbers: MS-06-03
• First Posted: Sep 25, 2008
• Last Update Posted: Feb 10, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: bilateral implantation; ReSTOR Aspheric IOL; uniocular unaided distance; binocular unaided distance; intermediate visual acuity; near visual acuity

Study Results

Participant Flow

Recruitment Details	Eligible patients with bilateral cataract were implanted with ReSTOR lens and followed up for 6-month after the 2nd eye implantation
Pre-assignment Detail	Open-label, single arm and nonrandomized

Arm/Group Title	AcrySof ReSTOR IOL
Arm/Group Description	Acrysof ReSTOR Intraocular Lens (IOL)
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	AcrySof ReSTOR IOL
Arm/Group Description	Acrysof ReSTOR Intraocular Lens (IOL)
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 10%
>=65 years	27 90%
Sex: Female, Male (Count of Participants)
Female	22 73.3%
Male	8 26.7%

Outcome Measures

1. Primary Outcome

Title	Near Uncorrected Visual Acuity(UCVA
Description	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.
Time Frame	6 months after surgery of 2nd eye

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AcrySof ReSTOR IOL
Arm/Group Description	Acrysof ReSTOR Intraocular Lens (IOL)
Measure Participants	30
Mean (Standard Deviation) [logMAR]	0.5 (0.12)

2. Secondary Outcome

Title	Contrast Sensitivity
Time Frame	6 months after sugery of the 2nd eye

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	AcrySof ReSTOR IOL
Arm/Group Description	Acrysof ReSTOR Intraocular Lens (IOL)
All Cause Mortality
	AcrySof ReSTOR IOL
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AcrySof ReSTOR IOL
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	AcrySof ReSTOR IOL
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.