Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

Cataract Clinical Trial

Official title:

Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934622
• Other study ID #: ALCONsur002.07
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2009
• Last updated: May 5, 2010
• Start date: November 2007

Study information

• Verified date: May 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AcrySof® ReSTOR® Aspheric IOL
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery

Locations

Country	Name	City	State
United States	Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	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.	pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery	Yes
Secondary	Spectacle Independence	Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.	pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery	Yes