CataractPhase 4NCT00684138

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

A Phase 4 study testing ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens and ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens in people with Cataract, run by Alcon Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Cataract
What is being tested?: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens and ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Jun 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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)

Show all 20Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Call Center for Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Conditions: Cataract
Being tested: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens, ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
Keywords: cataract, cataract surgery, IOL, intraocular lens, ReSTOR, Replacement of cataract
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular LensDevice
Intraocular Lens
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular LensDevice
Intraocular Lens

Study groups in NCT00684138
Study group	Role	What they receive
ReSTOR Aspheric +3.0D	Experimental	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens Receives: Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
ReSTOR Aspheric +4.0D	Active comparator	ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens Receives: Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months

Secondary outcomes (4)

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).
Measured: 3 months post-operative
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).
Measured: 3 months post-operative
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).
Measured: 3 months post-operative
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).
Measured: 3 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Jun 2008

First posted26 May 2008 (estimated)
Study startJun 2007
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00684138
Sponsor's protocol ID: C-06-40
Status last verified: Jul 2010
First submitted: 22 May 2008
Last updated: 13 Jul 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
ClinicalTrials.gov ID: NCT00684138
Acronym / sponsor ID: C-06-40
Conditions: Cataract
Keywords: cataract, cataract surgery, IOL, intraocular lens, ReSTOR, Replacement of cataract
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 26 May 2008 (estimated)
Results: Posted 11 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
ReSTOR Aspheric +3.0D	Experimental	Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular LensACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
ReSTOR Aspheric +4.0D	Active comparator	Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular LensACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular LensIntraocular Lens	Device	ReSTOR Aspheric +4.0D
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular LensIntraocular Lens	Device	ReSTOR Aspheric +3.0D

Primary outcome

Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
Time frame: 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.

4 secondary outcomes

Binocular Distance Corrected Distance Visual Acuity
Time frame: 3 months post-operative
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)
Time frame: 3 months post-operative
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)
Time frame: 3 months post-operative
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)
Time frame: 3 months post-operative

Results and safety

Results posted to the registry on 11 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACRYSOF® ReSTOR® +3.0	141	138
ACRYSOF® ReSTOR® Aspheric +4.0	139	131

Primary outcome: Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)

Time frame: 3 months. Mean (95% Confidence Interval). Unit: logMAR

Measure	ACRYSOF® ReSTOR® +3.0 n = 138	ACRYSOF® ReSTOR® Aspheric +4.0 n = 131
Value	0.07 (0.0539 to 0.0854)	0.09 (0.0854 to 0.1081)

Population analysed: 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).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to six months after cataract surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACRYSOF® ReSTOR® +3.0 (First Eyes)	6 of 153 (3.9%)	0 of 153 (0%)	Not reported
ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)	2 of 147 (1.4%)	0 of 147 (0%)	Not reported
ACRYSOF® ReSTOR® +3.0 (Second Eyes)	2 of 151 (1.3%)	0 of 151 (0%)	Not reported
ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)	3 of 143 (2.1%)	0 of 143 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00684138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2010.