Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00934622
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AcrySof® ReSTOR® Aspheric IOL AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)	Device: AcrySof® ReSTOR® Aspheric IOL; AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery]

   Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Secondary Outcome Measures

1. Spectacle Independence [pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery]

   Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 21 years or older;

• need spherical correction between 10-30 Diopters (D);

• corneal astigmatism less than 0.75D as measured by keratometry;

• willing to sign an Informed Consent Form and complete all visits;

• pupil dilation greater than 6mm;

• expected Visual Acuity (measured in logMAR)=0.3 or better

Exclusion Criteria:

• Women of childbearing potential;

• irregular corneal astigmatism;

• keratopathy/keratectasia;

• cornea inflammation or edema;

• cornea reshaping surgery;

• corneal dystrophy;corneal transplant;

• amblyopia;

• glaucoma;

• Retinal Pigment Epitheliopathy (RPE)/Macular changes;

• proliferative diabetic retinopathy

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: NCT00934622
• Other Study ID Numbers: ALCONsur002.07
• First Posted: Jul 8, 2009
• Last Update Posted: May 6, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: AcrySof; ReSTOR; Aspheric IOL; Cataract
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Subjects >21 years of age, either sex, and any race. Diagnosis of cataracts in both eyes. 27-Jun-2007 to 20-May-2009
Pre-assignment Detail	Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.

Arm/Group Title	AcrySof® ReSTOR® Aspheric IOL
Arm/Group Description	AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Period Title: Overall Study
STARTED	76
COMPLETED	68
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	AcrySof® ReSTOR® Aspheric IOL
Arm/Group Description	AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Overall Participants	76
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	33 43.4%
>=65 years	43 56.6%
Gender (participants) [Number]
Female	48 63.2%
Male	27 35.5%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time Frame	pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AcrySof® ReSTOR® Aspheric IOL
Arm/Group Description	AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Measure Participants	76
Preoperative	0.54 (0.3)
1 Week	0.06 (0.12)
1 Month	0.03 (0.08)
3 Months	0.04 (0.08)
6 Months	0.05 (0.09)

2. Secondary Outcome

Title	Spectacle Independence
Description	Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.
Time Frame	pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery

Outcome Measure Data

Analysis Population Description

Patient population was not consistent throughout the study. Number of patients analyzed at each visit is as follows: Preoperative n=76, Week 1 n=61, 1 Month n=71, 3 Months n=70, 6 Months n=68.

Arm/Group Title	AcrySof® ReSTOR® Aspheric IOL
Arm/Group Description	AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Measure Participants	76
Preoperative	29 38.2%
1 Week Postoperative	96.8 127.4%
1 Month Postoperative	97.2 127.9%
3 Months Postoperative	98.6 129.7%
6 Months Postoperative	100 131.6%

Adverse Events

Time Frame	June 27, 2007 (First Subject, first visit) through August 1, 2009 (Last subject, last visit)
Arm/Group Title	AcrySof® ReSTOR® Aspheric IOL
Arm/Group Description	AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
All Cause Mortality
	AcrySof® ReSTOR® Aspheric IOL
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AcrySof® ReSTOR® Aspheric IOL
	Affected / at Risk (%)	# Events
Total	0/76 (0%)
Other (Not Including Serious) Adverse Events
	AcrySof® ReSTOR® Aspheric IOL
	Affected / at Risk (%)	# Events
Total	0/76 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.