CataractNCT00759668

Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)

A study testing Acrysof Natural ReSTOR SN60D3 and Acrysof Natural Monofocal SN60AT 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

The purpose of the study is: to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal… Read more about this study

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Cataract
What is being tested?: Acrysof Natural ReSTOR SN60D3 and Acrysof Natural Monofocal SN60AT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: May 2007to Sep 2009
Phase: Interventional
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 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent
Age: ≥ 50 years ≤ 75 years
Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)
Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings
Potential post operative Visual Acuity (VA) ≥ 20/40
Second eye surgery to take place no longer than 45 days after the first implant

Who cannot join

Irregular optical aberrations;
Pupil diameter in scotopic conditions more than 6 mm
Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))
Other exclusions as from ReSTOR Directions for Use (DFU)

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

The purpose of the study is:

to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
to assess patient satisfaction before and after implant

Conditions: Cataract
Being tested: Acrysof Natural ReSTOR SN60D3, Acrysof Natural Monofocal SN60AT
Medical subject headings: Cataract

What participants receive

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

Acrysof Natural ReSTOR SN60D3Device
Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.
Acrysof Natural Monofocal SN60ATDevice
Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.

Study groups in NCT00759668
Study group	Role	What they receive
SN60D3	Experimental	AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3 Receives: Device: Acrysof Natural ReSTOR SN60D3
SN60AT	Active comparator	AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT Receives: Device: Acrysof Natural Monofocal SN60AT

What is being measured

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

Near Best Corrected Visual Acuity (BCVA) - Binocular
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Measured: 6 months after second eye implantation
Near Uncorrected Visual Acuity (UCVA) Binocular
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Measured: 6 months after second eye implantation
Near Best Corrected Visual Acuity Left Eye (BCVA LE)
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Measured: 6 months after second eye implantation
Near Uncorrected Visual Acuity Left Eye (UCVA LE)
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Measured: 6 months after second eye implantation
Near Best Corrected Visual Acuity Right Eye (BCVA RE)
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Measured: 6 months after second eye implantation
Near Uncorrected Visual Acuity Right Eye (UCVA RE)
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Measured: 6 months after second eye implantation

Timeline

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

May 2007Sep 2009

First posted25 Sep 2008 (estimated)
Study startMay 2007
Primary completionSep 2009
Study completionSep 2009

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00759668
Sponsor's protocol ID: IT 06 01
Status last verified: Jan 2011
First submitted: 24 Sep 2008
Last updated: 26 Jan 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 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
ClinicalTrials.gov ID: NCT00759668
Acronym / sponsor ID: IT 06 01
Conditions: Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 26 Jan 2011

Clinical summary

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

The purpose of the study is:

to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
to assess patient satisfaction before and after implant

Study design

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

Arm	Type	Receives
SN60D3	Experimental	Device: Acrysof Natural ReSTOR SN60D3AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3
SN60AT	Active comparator	Device: Acrysof Natural Monofocal SN60ATAcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Written informed consent
Age: ≥ 50 years ≤ 75 years
Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)
Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings
Potential post operative Visual Acuity (VA) ≥ 20/40

Key exclusion criteria (4 listed)

Irregular optical aberrations;
Pupil diameter in scotopic conditions more than 6 mm
Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))
Other exclusions as from ReSTOR Directions for Use (DFU)

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 Natural ReSTOR SN60D3Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.	Device	SN60D3
Acrysof Natural Monofocal SN60ATBilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.	Device	SN60AT

Primary outcome

Near Best Corrected Visual Acuity (BCVA) - Binocular
Time frame: 6 months after second eye implantation
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Near Uncorrected Visual Acuity (UCVA) Binocular
Time frame: 6 months after second eye implantation
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Near Best Corrected Visual Acuity Left Eye (BCVA LE)
Time frame: 6 months after second eye implantation
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Near Uncorrected Visual Acuity Left Eye (UCVA LE)
Time frame: 6 months after second eye implantation
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Near Best Corrected Visual Acuity Right Eye (BCVA RE)
Time frame: 6 months after second eye implantation
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Near Uncorrected Visual Acuity Right Eye (UCVA RE)
Time frame: 6 months after second eye implantation
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

Results and safety

Results posted to the registry on 26 Jan 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
SN60D3	17	16
SN60AT	18	15

Primary outcome: Near Best Corrected Visual Acuity (BCVA) - Binocular

Time frame: 6 months after second eye implantation. Number. Unit: Percentage of Participants

Measure	SN60D3 n = 16	SN60AT n = 16
Value	87.5	100

Population analysed: The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) \& were converted to LogMAR after inclusion in the database leading to data approximations.

Primary outcome: Near Uncorrected Visual Acuity (UCVA) Binocular

Time frame: 6 months after second eye implantation. Number. Unit: Percentage of Participants

Measure	SN60D3 n = 16	SN60AT n = 16
Value	100	31.25

Primary outcome: Near Best Corrected Visual Acuity Left Eye (BCVA LE)

Time frame: 6 months after second eye implantation. Number. Unit: Percentage of Participants

Measure	SN60D3 n = 16	SN60AT n = 16
Value	87.5	100

Primary outcome: Near Uncorrected Visual Acuity Left Eye (UCVA LE)

Time frame: 6 months after second eye implantation. Number. Unit: Percentage of Participants

Measure	SN60D3 n = 16	SN60AT n = 16
Value	100	18.75

Adverse events

Time frame: Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant). Other adverse events reported at 1.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SN60D3	1 of 17 (5.9%)	2 of 17 (11.8%)	Not reported
SN60AT	1 of 118 (0.8%)	3 of 18 (16.7%)	Not reported

Limitations and caveats (from the sponsor): Visual acuity data were collected in different units (i.e. c, twentieth, decimal, Jaeger) and were converted to LogMAR after inclusion in the database. This led to inevitable approximations of the data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Acrysof Natural ReSTOR SN60D3 and Acrysof Natural Monofocal SN60AT in people with Cataract, 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 6 inclusion and 4 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 26 Jan 2011. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 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?

Near Best Corrected Visual Acuity (BCVA) - Binocular (time frame: 6 months after second eye implantation). The study lists 6 primary outcomes in all. 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 NCT00759668.

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 26 Jan 2011; AzTrials last refreshed its copy on 30 Oct 2026.