CataractPhase 4NCT01166971

A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

A Phase 4 study testing ReSTOR +3 and Tecnis MF in people with Cataract, run by Alcon Research at 3 sites 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

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Cataract
What is being tested?: ReSTOR +3 and Tecnis MF
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 3 sitesUnited States
Study dates: Jul 2010to Mar 2011
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

diagnosed with bilateral cataracts
candidate for presbyopic lens

Who cannot join

>1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
pre-existing conditions that could skew the results

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Carolina Eye Care Physicians
Charleston, South Carolina, 29414
Whitsett Vision Group
Houston, Texas, 77055
The Eye Center of North Florida
Panama City, Florida, 32405

Other trials in United States

About this study

Official title: A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs

Conditions: Cataract
Being tested: ReSTOR +3, Tecnis MF
Keywords: presbyopia, intraocular lens
Medical subject headings: Cataract, Presbyopia

What participants receive

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

ReSTOR +3Device
Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction
Tecnis MFDevice
Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction

Study groups in NCT01166971
Study group	Role	What they receive
ReSTOR +3	Experimental	Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction Receives: Device: ReSTOR +3
Tecnis MF	Active comparator	Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction Receives: Device: Tecnis MF

What is being measured

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

Defocus Curve
A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".
Measured: 3 months after surgery

Timeline

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

Jul 2010Mar 2011

First posted21 Jul 2010 (estimated)
Study startJul 2010
Primary completionMar 2011

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.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01166971
Sponsor's protocol ID: M09-050
Status last verified: Nov 2011
First submitted: 19 Jul 2010
Last updated: 24 Nov 2011
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?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
ClinicalTrials.gov ID: NCT01166971
Acronym / sponsor ID: M09-050
Conditions: Cataract
Keywords: presbyopia, intraocular lens
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Mar 2011 (actual)
First posted: 21 Jul 2010 (estimated)
Results: Posted 8 Nov 2011

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: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
ReSTOR +3	Experimental	Device: ReSTOR +3Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
Tecnis MF	Active comparator	Device: Tecnis MFBilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction

Who may qualify

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

Key inclusion criteria (2 listed)

diagnosed with bilateral cataracts
candidate for presbyopic lens

Key exclusion criteria (2 listed)

>1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
pre-existing conditions that could skew the results

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
ReSTOR +3Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction	Device	ReSTOR +3
Tecnis MFBilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction	Device	Tecnis MF

Primary outcome

Defocus Curve
Time frame: 3 months after surgery
A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".

Results and safety

Results posted to the registry on 8 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ReSTOR +3	33	32
Tecnis MF	31	30

Primary outcome: Defocus Curve

Time frame: 3 months after surgery. Mean (Standard Deviation). Unit: LogMAR

Measure	ReSTOR +3 n = 33	Tecnis MF n = 29
-5.00 Diopter (D)	0.585 (0.204)	0.653 (0.116)
-4.50 D	0.490 (0.204)	0.475 (0.115)
-4.00 D	0.388 (0.189)	0.337 (0.107)
-3.50 D	0.261 (0.183)	0.168 (0.114)
-3.00 D	0.126 (0.185)	0.046 (0.104)
-2.50 D	0.017 (0.144)	0.073 (0.113)
-2.00 D	0.055 (0.147)	0.222 (0.178)
-1.50 D	0.245 (0.175)	0.326 (0.120)

Population analysed: In the ReSTOR +3 population, 1 subject did not complete the assessment at -5.00 D; therefore, only 32 subjects were used for this measure.

Adverse events

Time frame: Adverse events were collected at all study visits.. Other adverse events reported at 3.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ReSTOR +3	0 of 32 (0%)	0 of 32 (0%)	Not reported
Tecnis MF	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
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.

3 sites 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 +3 and Tecnis MF in people with Cataract, run by Alcon Research at 3 sites 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 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 8 Nov 2011). 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?

Defocus Curve (time frame: 3 months after surgery). 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 NCT01166971.

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 24 Nov 2011.