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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684138
• Other study ID #: C-06-40
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2008
• Last updated: July 6, 2010
• Start date: June 2007
• Est. completion date: June 2008

Study information

• Verified date: July 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Intraocular Lens
• ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
Intraocular Lens

Locations

Country	Name	City	State
United States	Call Center for 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	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.	3 months	No
Secondary	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).	3 months post-operative	No
Secondary	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).	3 months post-operative	No
Secondary	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).	3 months post-operative	No
Secondary	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).	3 months post-operative	No