search
Back to results

ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
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 cataract, cataract surgery, IOL, intraocular lens, ReSTOR, Replacement of cataract

Eligibility Criteria

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

Inclusion:

  • Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts
  • Calculated lens power is within the available range
  • Willing and able to complete all required postoperative visits
  • Planned cataract removal by phacoemulsification and/or liquifacture
  • Potential postoperative visual acuity of 0.2 logMAR or better in study eyes
  • Preoperative astigmatism of 1.0 Diopter (D) or less, measured by keratometry in study eyes
  • Clear intraocular media other than cataract in study eyes
  • Able to comprehend and sign a statement of informed consent
  • Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR, or if BCDVA is equal to or better than 0.2 logMAR, BCDVA with a Brightness Acuity Tester (BAT) on "Medium" setting must be worse than 0.2 logMAR

Exclusion:

  • Significant irregular corneal aberration as demonstrated by corneal topography
  • Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR
  • Subjects who may reasonably be expected to require laser treatments at any time
  • Previous corneal refractive surgery
  • Amblyopia
  • Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
  • Diabetic retinopathy
  • Extremely shallow anterior chamber, not due to swollen cataract
  • Microphthalmos
  • Previous retinal detachment
  • Previous corneal transplant
  • Recurrent severe anterior or posterior segment inflammation of unknown etiology
  • Rubella or traumatic cataract
  • Iris neovascularization
  • Glaucoma (uncontrolled or controlled with medication)
  • Aniridia
  • Optic nerve atrophy
  • Pregnancy
  • Current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g.Flomax® (tamsulosin HCL), Hytrin®, or Cardura®)
  • Any subject currently participating in another investigational drug or device study that may confound the results of this investigation

Sites / Locations

  • Call Center for Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ReSTOR Aspheric +3.0D

ReSTOR Aspheric +4.0D

Arm Description

ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens

ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens

Outcomes

Primary Outcome Measures

Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.

Secondary Outcome Measures

Binocular Distance Corrected Distance Visual Acuity
Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)
Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)
Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)
Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Full Information

First Posted
May 22, 2008
Last Updated
July 6, 2010
Sponsor
Alcon Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00684138
Brief Title
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
Official Title
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized, parallel group, subject masked, multi-center six (6) month follow-up study comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract, cataract surgery, IOL, intraocular lens, ReSTOR, Replacement of cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ReSTOR Aspheric +3.0D
Arm Type
Experimental
Arm Description
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
Arm Title
ReSTOR Aspheric +4.0D
Arm Type
Active Comparator
Arm Description
ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Intervention Type
Device
Intervention Name(s)
ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Intervention Description
Intraocular Lens
Intervention Type
Device
Intervention Name(s)
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
Intervention Description
Intraocular Lens
Primary Outcome Measure Information:
Title
Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
Description
Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Binocular Distance Corrected Distance Visual Acuity
Description
Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time Frame
3 months post-operative
Title
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)
Description
Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time Frame
3 months post-operative
Title
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)
Description
Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time Frame
3 months post-operative
Title
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)
Description
Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time Frame
3 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts Calculated lens power is within the available range Willing and able to complete all required postoperative visits Planned cataract removal by phacoemulsification and/or liquifacture Potential postoperative visual acuity of 0.2 logMAR or better in study eyes Preoperative astigmatism of 1.0 Diopter (D) or less, measured by keratometry in study eyes Clear intraocular media other than cataract in study eyes Able to comprehend and sign a statement of informed consent Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR, or if BCDVA is equal to or better than 0.2 logMAR, BCDVA with a Brightness Acuity Tester (BAT) on "Medium" setting must be worse than 0.2 logMAR Exclusion: Significant irregular corneal aberration as demonstrated by corneal topography Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR Subjects who may reasonably be expected to require laser treatments at any time Previous corneal refractive surgery Amblyopia Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy) Diabetic retinopathy Extremely shallow anterior chamber, not due to swollen cataract Microphthalmos Previous retinal detachment Previous corneal transplant Recurrent severe anterior or posterior segment inflammation of unknown etiology Rubella or traumatic cataract Iris neovascularization Glaucoma (uncontrolled or controlled with medication) Aniridia Optic nerve atrophy Pregnancy Current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g.Flomax® (tamsulosin HCL), Hytrin®, or Cardura®) Any subject currently participating in another investigational drug or device study that may confound the results of this investigation
Facility Information:
Facility Name
Call Center for Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

We'll reach out to this number within 24 hrs