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

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00684138
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
12
Duration (Months)
24.9
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
  • Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

ArmIntervention/Treatment
Experimental: ReSTOR Aspheric +3.0D

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

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

Active Comparator: ReSTOR Aspheric +4.0D

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

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

Outcome Measures

Primary Outcome Measures

  1. Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) [3 months]

    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

  1. Binocular Distance Corrected Distance Visual Acuity [3 months post-operative]

    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).

  2. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm) [3 months post-operative]

    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. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm) [3 months post-operative]

    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).

  4. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm) [3 months post-operative]

    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).

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Call Center for LocationsFort WorthTexasUnited States76134

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00684138
Other Study ID Numbers:
  • C-06-40
First Posted:
May 26, 2008
Last Update Posted:
Jul 13, 2010
Last Verified:
Jul 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsOnly adult subjects of either gender or any race in need of cataract extraction in both eyes were considered for enrollment. 280 subjects were implanted bilaterally with either the ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 or the ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 based upon a 1:1 randomization.
Pre-assignment DetailSubjects were examined to ensure inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study were enrolled. Subject numbers were assigned after obtaining consent meeting inclusion/exclusion criteria. Subjects were considered enrolled once implanted in the first operative eye.
Arm/Group TitleACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group DescriptionACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular LensACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Period Title: Overall Study
STARTED141139
COMPLETED138131
NOT COMPLETED38

Baseline Characteristics

Arm/Group TitleACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0Total
Arm/Group DescriptionACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular LensACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular LensTotal of all reporting groups
Overall Participants141139280
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
51
36.2%
40
28.8%
91
32.5%
>=65 years
90
63.8%
99
71.2%
189
67.5%
Sex: Female, Male (Count of Participants)
Female
95
67.4%
97
69.8%
192
68.6%
Male
46
32.6%
42
30.2%
88
31.4%

Outcome Measures

1. Primary Outcome
TitleBinocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
DescriptionBinocular 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 Frame3 months

Outcome Measure Data

Analysis Population Description
Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).
Arm/Group TitleACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group DescriptionACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular LensACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Measure Participants138131
Mean (95% Confidence Interval) [logMAR]
0.07
0.09
2. Secondary Outcome
TitleBinocular Distance Corrected Distance Visual Acuity
DescriptionBinocular 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 Frame3 months post-operative

Outcome Measure Data

Analysis Population Description
Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).
Arm/Group TitleACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group DescriptionACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular LensACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Measure Participants138131
Mean (95% Confidence Interval) [logMAR]
-0.05
-0.05
3. Secondary Outcome
TitleBinocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)
DescriptionBinocular 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 Frame3 months post-operative

Outcome Measure Data

Analysis Population Description
Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).
Arm/Group TitleACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group DescriptionACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular LensACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Measure Participants138131
Mean (95% Confidence Interval) [logMAR]
0.06
0.24
4. Secondary Outcome
TitleBinocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)
DescriptionBinocular 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 Frame3 months post-operative

Outcome Measure Data

Analysis Population Description
Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).
Arm/Group TitleACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group DescriptionACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular LensACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Measure Participants138131
Mean (95% Confidence Interval) [logMAR]
0.12
0.32
5. Secondary Outcome
TitleBinocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)
DescriptionBinocular 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 Frame3 months post-operative

Outcome Measure Data

Analysis Population Description
Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).
Arm/Group TitleACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group DescriptionACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular LensACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Measure Participants138131
Mean (95% Confidence Interval) [logMAR]
0.18
0.34

Adverse Events

Time FrameUp to six months after cataract surgery.
Adverse Event Reporting Description Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.
Arm/Group TitleACRYSOF® ReSTOR® +3.0 (First Eyes)ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)ACRYSOF® ReSTOR® +3.0 (Second Eyes)ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)
Arm/Group DescriptionACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - First eye implanted onlyACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - First eye implanted onlyACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - Second eye implanted onlyACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - Second eye implanted only
All Cause Mortality
ACRYSOF® ReSTOR® +3.0 (First Eyes)ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)ACRYSOF® ReSTOR® +3.0 (Second Eyes)ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
ACRYSOF® ReSTOR® +3.0 (First Eyes)ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)ACRYSOF® ReSTOR® +3.0 (Second Eyes)ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total6/153 (3.9%) 2/147 (1.4%) 2/151 (1.3%) 3/143 (2.1%)
Eye disorders
Hypopyon1/153 (0.7%) 10/147 (0%) 00/151 (0%) 00/143 (0%) 0
Endophthalmitis1/153 (0.7%) 10/147 (0%) 00/151 (0%) 00/143 (0%) 0
Macular Edema4/153 (2.6%) 42/147 (1.4%) 20/151 (0%) 01/143 (0.7%) 1
Lens Dislocation1/153 (0.7%) 10/147 (0%) 00/151 (0%) 00/143 (0%) 0
Surgical and medical procedures
Surgical reintervention (SI)2/153 (1.3%) 51/147 (0.7%) 12/151 (1.3%) 22/143 (1.4%) 2
Other (Not Including Serious) Adverse Events
ACRYSOF® ReSTOR® +3.0 (First Eyes)ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)ACRYSOF® ReSTOR® +3.0 (Second Eyes)ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/153 (0%) 0/147 (0%) 0/151 (0%) 0/143 (0%)

Limitations/Caveats

Data from one investigator, who implanted 20 subjects, were excluded from analysis due to non compliance with data collection and documentation. This resulted in 280 implanted subjects that were considered evaluable.

More Information

Certain Agreements

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

Results Point of Contact

Name/TitleAlcon Clinical
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00684138
Other Study ID Numbers:
  • C-06-40
First Posted:
May 26, 2008
Last Update Posted:
Jul 13, 2010
Last Verified:
Jul 1, 2010