Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00818116
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Device: AcrySof ReSTOR Aspheric IOL	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric Intraocular Lens (IOL): Postmarket Evaluation
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR Aspheric IOL Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)	Device: AcrySof ReSTOR Aspheric IOL; Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.

Outcome Measures

Primary Outcome Measures

1. Uncorrected and Best Corrected Visual Acuities (Near and Distance) [6 Months Following Cataract Surgery]

   Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.

• 50~75 years of age

• <1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.

Exclusion Criteria:

• Patients with pre-existing conditions that could skew the results.

• Any of conditions before and during surgery specified in the product information.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center for Trial Locations	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: NCT00818116
• Other Study ID Numbers: CH-08-001
• First Posted: Jan 7, 2009
• Last Update Posted: Jul 30, 2010
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: Cataract; visual acuity; AcrySof ReSTOR Aspheric Intraoculare Lens; Bilateral cataract
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	34 eligible patients were enrolled into the study
Pre-assignment Detail	Open-label, single arm, non-randomized

Arm/Group Title	ReSTOR Aspheric
Arm/Group Description	Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Period Title: Overall Study
STARTED	34
COMPLETED	34
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	ReSTOR Aspheric
Arm/Group Description	Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Overall Participants	34
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 41.2%
>=65 years	20 58.8%
Sex: Female, Male (Count of Participants)
Female	24 70.6%
Male	10 29.4%

Outcome Measures

1. Primary Outcome

Title	Uncorrected and Best Corrected Visual Acuities (Near and Distance)
Description	Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time Frame	6 Months Following Cataract Surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Aspheric
Arm/Group Description	Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Measure Participants	34
Near Uncorrected Visual Acuity	0.02 (0.08)
Near Best-Corrected Visual Acuity	0.01 (0.07)
Distance Uncorrected Visual Acuity	0.00 (0.07)
Distance Best-Corrected Visual Acuity	-0.03 (0.07)

Adverse Events

Time Frame	1 Day, 1 Month, 3 Months, and 6 Months following cataract surgery.
Arm/Group Title	ReSTOR Aspheric
Arm/Group Description	Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
All Cause Mortality
	ReSTOR Aspheric
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ReSTOR Aspheric
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Other (Not Including Serious) Adverse Events
	ReSTOR Aspheric
	Affected / at Risk (%)	# Events
Total	1/34 (2.9%)
Eye disorders
Glare	1/34 (2.9%)	1

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.