CataractPhase 4NCT00934622
Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL
A Phase 4 study testing AcrySof® ReSTOR® Aspheric IOL in people with Cataract, run by Alcon Research at 1 site in United States.
Trial summary
This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- AcrySof® ReSTOR® Aspheric IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Mar 2009
- 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
- 21 years or older;
- need spherical correction between 10-30 Diopters (D);
- corneal astigmatism less than 0.75D as measured by keratometry;
- willing to sign an Informed Consent Form and complete all visits;
- pupil dilation greater than 6mm;
- expected Visual Acuity (measured in logMAR)=0.3 or better
Who cannot join
- Women of childbearing potential;
- irregular corneal astigmatism;
- keratopathy/keratectasia;
- cornea inflammation or edema;
- cornea reshaping surgery;
- corneal dystrophy;corneal transplant;
Show all 10Show fewer
- amblyopia;
- glaucoma;
- Retinal Pigment Epitheliopathy (RPE)/Macular changes;
- proliferative diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)
This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.
- Conditions
- Cataract
- Being tested
- AcrySof® ReSTOR® Aspheric IOL
- Keywords
- AcrySof, ReSTOR, Aspheric IOL, Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof® ReSTOR® Aspheric IOLDevice
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery
| Study group | Role | What they receive |
|---|---|---|
| AcrySof® ReSTOR® Aspheric IOL | Experimental | AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Receives: Device: AcrySof® ReSTOR® Aspheric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Measured: pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery
Secondary outcomes (1)
Spectacle Independence
Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.
Measured: pre-op;1 week,1 month,3 months and 6 months 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 posted8 Jul 2009 (estimated)
- Study startNov 2007
- Primary completionMar 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.
- 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
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934622
- Sponsor's protocol ID
- ALCONsur002.07
- Status last verified
- May 2010
- First submitted
- 7 Jul 2009
- Last updated
- 6 May 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT00934622
- Acronym / sponsor ID
- ALCONsur002.07
- Conditions
- Cataract
- Keywords
- AcrySof, ReSTOR, Aspheric IOL, Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Mar 2009 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Posted 6 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AcrySof® ReSTOR® Aspheric IOL | Experimental | Device: AcrySof® ReSTOR® Aspheric IOLAcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 21 years or older;
- need spherical correction between 10-30 Diopters (D);
- corneal astigmatism less than 0.75D as measured by keratometry;
- willing to sign an Informed Consent Form and complete all visits;
- pupil dilation greater than 6mm;
Key exclusion criteria (10 listed)
- Women of childbearing potential;
- irregular corneal astigmatism;
- keratopathy/keratectasia;
- cornea inflammation or edema;
- cornea reshaping surgery;
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® Aspheric IOLAcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery | Device | AcrySof® ReSTOR® Aspheric IOL |
Primary outcome
Visual Acuity
Time frame: pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery
Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
1 secondary outcome
Spectacle Independence
Time frame: pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2010.
- 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 Phase 4 study testing AcrySof® ReSTOR® Aspheric IOL 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 10 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 6 May 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 6 May 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: pre-operative;1 week,1 month, 3 months and 6 months 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 6 May 2010.