Visual OutcomesPhase 4NCT00758940
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
A Phase 4 study testing Acrysof ReSTOR multifocal IOL in people with Visual Outcomes, run by Alcon Research at 1 site in United States.
Trial summary
An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are at least 30 patients or as much as possible from the doctor's clinical practice perspective. 6 months follow-up after IOL implant in the 2nd eye Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Visual Outcomes
- What is being tested?
- Acrysof ReSTOR multifocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Able to complete all required postoperative visits; Planned cataract removal by phaco; 21 years of age or older, either gender or any race; potential postoperative visual acuity of 20/20; astigmatism ≦1.0D measured by keratometry in study eye(s);clear int
Who cannot join
- Signs of capsular tear, significant anterior chamber hyphema;zonular rupture; corneal pathology and refractive surgery;hypercritical patient; patients with unrealistic expectations in post-op VA; happy to wear glasses;occupational night drivers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Six-months, Open-labelled Clinical Assessment of Visual Function After Bilateral Implantation of Arcysof ReSTOR Multifocal Intra-ocular Lens
An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are at least 30 patients or as much as possible from the doctor's clinical practice perspective. 6 months follow-up after IOL implant in the 2nd eye
- Conditions
- Visual Outcomes
- Being tested
- Acrysof ReSTOR multifocal IOL
- Keywords
- Clinical, assessment, of visual, function, with the Acrysof ReSTOR, multifocal IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acrysof ReSTOR multifocal IOLDevice
Implanted into the study eye following cataract extraction surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Acrysof ReSTOR multifocal IOL Receives: Device: Acrysof ReSTOR multifocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near,intermediate,distance visual acuity
Measured: pre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery
Secondary outcomes (1)
contrast sensitivity
Measured: 6 month after 2nd eye surgery
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)
Why it stopped: Primary Investigator resigned from Hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual OutcomesStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758940
- Sponsor's protocol ID
- HK-Restor-YIU-01
- Status last verified
- Jan 2010
- First submitted
- 23 Sep 2008
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-months, Open-labelled Clinical Assessment of Visual Function After Bilateral Implantation of Arcysof ReSTOR Multifocal Intra-ocular Lens
- ClinicalTrials.gov ID
- NCT00758940
- Acronym / sponsor ID
- HK-Restor-YIU-01
- Conditions
- Visual Outcomes
- Keywords
- Clinical, assessment, of visual, function, with the Acrysof ReSTOR, multifocal IOL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Primary Investigator resigned from Hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are at least 30 patients or as much as possible from the doctor's clinical practice perspective. 6 months follow-up after IOL implant in the 2nd eye
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Acrysof ReSTOR multifocal IOLAcrysof ReSTOR multifocal IOL |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to complete all required postoperative visits; Planned cataract removal by phaco; 21 years of age or older, either gender or any race; potential postoperative visual acuity of 20/20; astigmatism ≦1.0D measured by keratometry in study eye(s);clear int
Key exclusion criteria (1 listed)
- Signs of capsular tear, significant anterior chamber hyphema;zonular rupture; corneal pathology and refractive surgery;hypercritical patient; patients with unrealistic expectations in post-op VA; happy to wear glasses;occupational night drivers
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 multifocal IOLImplanted into the study eye following cataract extraction surgery | Device | 1 |
Primary outcome
Near,intermediate,distance visual acuity
Time frame: pre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery
1 secondary outcome
contrast sensitivity
Time frame: 6 month after 2nd eye surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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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 Acrysof ReSTOR multifocal IOL in people with Visual Outcomes, 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 12 May 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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,intermediate,distance visual acuity (time frame: pre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery). 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 12 May 2015.