Visual AcuityNCT00759096
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
A study testing RESTOR IOL Model SA60D3 in people with Visual Acuity, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Visual Acuity
- What is being tested?
- RESTOR IOL Model SA60D3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jul 2008
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥21 years of either gender or any race
- Potential post-op VA 20/20
- Pre-op astigmatism ≤ 1.0D
- Able to sign the informed consent
- Able to complete all required postoperative visits
- Planned cataract removal by phaco
- Clear intraocular media other than cataract
Who cannot join
- Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
- Any corneal pathology and previous corneal refractive surgery
- Patients with unrealistic expectations in anticipated post-op VA
- Happy to wear glasses
- Occupational night driver
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.
- Conditions
- Visual Acuity
- Being tested
- RESTOR IOL Model SA60D3
- Keywords
- bilateral implantation, ReSTOR Aspheric IOL, uniocular unaided distance, binocular unaided distance, intermediate visual acuity, near visual acuity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTOR IOL Model SA60D3Device
Implanted into the study eye following cataract extraction surgery
| Study group | Role | What they receive |
|---|---|---|
| Acrysof ReSTOR IOL | Experimental | AcrySof ReSTOR Intraocular lens (IOL) implanted Receives: Device: RESTOR IOL Model SA60D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Uncorrected Visual Acuity(UCVA
Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.
Measured: 6 months after surgery of 2nd eye
Secondary outcomes (1)
Contrast Sensitivity
Measured: 6 months after sugery of the 2nd eye
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionJul 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 Visual AcuityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759096
- Sponsor's protocol ID
- MS-06-03
- Status last verified
- Jan 2010
- First submitted
- 23 Sep 2008
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
- ClinicalTrials.gov ID
- NCT00759096
- Acronym / sponsor ID
- MS-06-03
- Conditions
- Visual Acuity
- Keywords
- bilateral implantation, ReSTOR Aspheric IOL, uniocular unaided distance, binocular unaided distance, intermediate visual acuity, near visual acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 10 Feb 2010
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 this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acrysof ReSTOR IOL | Experimental | Device: RESTOR IOL Model SA60D3AcrySof ReSTOR Intraocular lens (IOL) implanted |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥21 years of either gender or any race
- Potential post-op VA 20/20
- Pre-op astigmatism ≤ 1.0D
- Able to sign the informed consent
- Able to complete all required postoperative visits
Key exclusion criteria (5 listed)
- Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
- Any corneal pathology and previous corneal refractive surgery
- Patients with unrealistic expectations in anticipated post-op VA
- Happy to wear glasses
- Occupational night driver
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 IOL Model SA60D3Implanted into the study eye following cataract extraction surgery | Device | Acrysof ReSTOR IOL |
Primary outcome
Near Uncorrected Visual Acuity(UCVA
Time frame: 6 months after surgery of 2nd eye
Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.
1 secondary outcome
Contrast Sensitivity
Time frame: 6 months after sugery of the 2nd eye
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- 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 RESTOR IOL Model SA60D3 in people with Visual Acuity, 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 7 inclusion and 5 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 5 Dec 2023. 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 10 Feb 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?
Near Uncorrected Visual Acuity(UCVA (time frame: 6 months after surgery of 2nd eye). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2023.