CataractNCT00758745
Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
A study testing Model SN60WF and Model MA60AC in people with Cataract, run by Alcon Research at 1 site in United States.
Trial summary
Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Model SN60WF and Model MA60AC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50 years
- Clear cornea
- Pupil mydriasis ≥ 7mm
- In the bag Intraocular Lens (IOL)
Who cannot join
- Ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (PEX), high myopia
- Previously operated eye
- Proliferative diabetic retinopathy
- Surgical complications - incomplete rhexis, post capsular rupture (PCR), zonular dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, 76134
About this study
Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).
- Conditions
- Cataract
- Being tested
- Model SN60WF, Model MA60AC
- Keywords
- Cataract, Patients, bilateral, age related, undergoing, phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model SN60WFDevice
Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.
Model MA60ACDevice
Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Model SN60WF | Active comparator | Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) Receives: Device: Model SN60WF |
| Model MA60AC | Active comparator | Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) Receives: Device: Model MA60AC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior Capsule Opacification (PCO)
Development of PCO using the EPCO Score. The EPCO score incorporates planimetric \& grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.
Measured: Up to 3 years
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 startJan 2006
- Primary completionDec 2009
- Study completionDec 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 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
- NCT00758745
- Sponsor's protocol ID
- P-06-03
- Status last verified
- Aug 2011
- First submitted
- 23 Sep 2008
- Last updated
- 19 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
- ClinicalTrials.gov ID
- NCT00758745
- Acronym / sponsor ID
- P-06-03
- Conditions
- Cataract
- Keywords
- Cataract, Patients, bilateral, age related, undergoing, phacoemulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 28 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model SN60WF | Active comparator | Device: Model SN60WFImplantation with the AcrySof Model SN60WF Intraocular Lens (IOL) |
| Model MA60AC | Active comparator | Device: Model MA60ACImplantation with the AcrySof Model MA60AC Intraocular Lens (IOL) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 50 years
- Clear cornea
- Pupil mydriasis ≥ 7mm
- In the bag Intraocular Lens (IOL)
Key exclusion criteria (4 listed)
- Ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (PEX), high myopia
- Previously operated eye
- Proliferative diabetic retinopathy
- Surgical complications - incomplete rhexis, post capsular rupture (PCR), zonular dialysis
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 |
|---|---|---|
| Model SN60WFImplantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal. | Device | Model SN60WF |
| Model MA60ACImplantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery. | Device | Model MA60AC |
Primary outcome
Posterior Capsule Opacification (PCO)
Time frame: Up to 3 years
Development of PCO using the EPCO Score. The EPCO score incorporates planimetric \& grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- 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 Model SN60WF and Model MA60AC 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 4 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 19 Aug 2014. 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 28 Jul 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?
Posterior Capsule Opacification (PCO) (time frame: Up to 3 years). 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 19 Aug 2014.