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Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AcrySof® ReSTOR® Aspheric IOL
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring AcrySof, ReSTOR, Aspheric IOL, Cataract

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AcrySof® ReSTOR® Aspheric IOL

Arm Description

AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2009
Last Updated
May 5, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00934622
Brief Title
Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL
Official Title
Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
AcrySof, ReSTOR, Aspheric IOL, Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AcrySof® ReSTOR® Aspheric IOL
Arm Type
Experimental
Arm Description
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Intervention Type
Device
Intervention Name(s)
AcrySof® ReSTOR® Aspheric IOL
Intervention Description
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

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