CataractsPhase 4NCT00731640

Contralateral ReSTOR / Monofocal or Phakic Eye

A Phase 4 study testing ReSTOR in people with Cataracts, 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.

Trial summary

Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cataracts
What is being tested?: ReSTOR
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: Jun 2007to May 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Unilateral operable cataract
Candidate for presbyopic intraocular lens (IOL)

Who cannot join

Ocular comorbidities compromising primary outcome
Bilateral cataracts

Trial locations and contacts

1 site in 1 country.

United States1 site

Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive Intraocular Lens (IOL) in One Eye and a Contralateral Monofocal IOL or Phakic Eye

Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

Conditions: Cataracts
Being tested: ReSTOR
Keywords: AcrySof, ReSTOR, Multifocal, Intraocular Lens
Medical subject headings: Cataract

What participants receive

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

ReSTORDevice
AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted

Study groups in NCT00731640
Study group	Role	What they receive
Monofocal	Active comparator	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye Receives: Device: ReSTOR
Phakic	Active comparator	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending Receives: Device: ReSTOR

What is being measured

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

Visual Acuity
Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Measured: 6 months

Secondary outcomes (3)

Contrast Sensitivity
Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
Measured: 6 Months
Patient Satisfaction
Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).
Measured: 6 Months Postoperative
Spectacle Independence
The percentage of patients reporting spectacle independence (no longer needing to wear glasses).
Measured: 6 Months

Timeline

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

Jun 2007May 2008

First posted11 Aug 2008 (estimated)
Study startJun 2007
Primary completionMay 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 CataractsStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00731640
Sponsor's protocol ID: M07-012
Status last verified: Mar 2010
First submitted: 7 Aug 2008
Last updated: 23 Mar 2010
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
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Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
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Not yet recruitingObservational study
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All Cataracts trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive Intraocular Lens (IOL) in One Eye and a Contralateral Monofocal IOL or Phakic Eye
ClinicalTrials.gov ID: NCT00731640
Acronym / sponsor ID: M07-012
Conditions: Cataracts
Keywords: AcrySof, ReSTOR, Multifocal, Intraocular Lens
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: May 2008 (actual)
First posted: 11 Aug 2008 (estimated)
Results: Posted 16 Mar 2010

Clinical summary

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

Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Monofocal	Active comparator	Device: ReSTORPatients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye
Phakic	Active comparator	Device: ReSTORPatients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Unilateral operable cataract
Candidate for presbyopic intraocular lens (IOL)

Key exclusion criteria (2 listed)

Ocular comorbidities compromising primary outcome
Bilateral cataracts

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
ReSTORAcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted	Device	Monofocal, Phakic

Primary outcome

Visual Acuity
Time frame: 6 months
Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

3 secondary outcomes

Contrast Sensitivity
Time frame: 6 Months
Patient Satisfaction
Time frame: 6 Months Postoperative
Spectacle Independence
Time frame: 6 Months

Results and safety

Results posted to the registry on 16 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
Monofocal	20	20
Phakic	32	32

Primary outcome: Visual Acuity

Time frame: 6 months. Mean (Standard Deviation). Unit: LogMar

Measure	Monofocal n = 20	Phakic n = 32
Distance	-0.04 (0.09)	-0.01 (0.09)
Intermediate	0.14 (0.13)	0.18 (0.15)
Near (Preferred Distance)	0.04 (0.10)	0.09 (0.12)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Monofocal	0 of 20 (0%)	0 of 20 (0%)	Not reported
Phakic	0 of 32 (0%)	0 of 32 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataracts

RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
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Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
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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?

A Phase 4 study testing ReSTOR in people with Cataracts, run by Alcon Research at 1 site in United States.

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 2 inclusion and 2 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 23 Mar 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 16 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?

Visual Acuity (time frame: 6 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 NCT00731640.

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 23 Mar 2010.