CataractsNCT01105585
A Comparative Pilot Study Of High-Order Aberrations With Aspheric IOL Models SN60WF and ZCB00
A study testing Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL and AcrySof Natural IQ (SN60WF) IOL in people with Cataracts, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to prospectively compare high-order aberrations between eyes implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted with the Tecnis ZCB00 IOL. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL and AcrySof Natural IQ (SN60WF) IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2011
- Phase
- Interventional
- 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
- Requires bilateral extraction of cataracts by phacoemulsification followed by implantation of a posterior chamber intraocular lens;
- Confirmed absence of pre-existing conditions that could skew the results or present contraindications for the IQ intraocular lens (IOL) or the Tecnis ZCB00 IOL;
- <1 diopter corneal astigmatism preoperatively;
- Able to achieve 6.5 mm dilated pupil;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Chronic disease or illness;
- Irregular optical aberration;
- Amblyopia;
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
- Diabetic retinopathy;
- Macular degeneration;
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- History of retinal detachment;
- Other surgeries planned at time of cataract removal;
- Severe dry eye;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: A Comparative Pilot Study Of High-Order Aberrations With Aspheric Intraocular Lens (IOL) Models SN60WF And ZCB00
The purpose of this study was to prospectively compare high-order aberrations between eyes implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted with the Tecnis ZCB00 IOL.
- Conditions
- Cataracts
- Being tested
- Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL, AcrySof Natural IQ (SN60WF) IOL
- Keywords
- Cataracts, aspheric, IOL, ocular aberrations
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis 1-piece Aspheric Acrylic (ZCB00) IOLDevice
Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.
AcrySof Natural IQ (SN60WF) IOLDevice
AcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.
| Study group | Role | What they receive |
|---|---|---|
| ZCB00 IOL | Experimental | Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens (IOL) randomly assigned to one eye, with AcrySof Natural IQ (SN60WF) IOL in the fellow eye for contralateral implantation Receives: Device: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL |
| SN60WF IOL | Active comparator | AcrySof Natural IQ (SN60WF) intraocular lens (IOL) randomly assigned to one eye, with Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens in the fellow eye for contralateral implantation Receives: Device: AcrySof Natural IQ (SN60WF) IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total ocular high-order aberrations
Measured: Month 1 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT01105585
- Sponsor's protocol ID
- M-09-003
- Status last verified
- Nov 2012
- First submitted
- 15 Apr 2010
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Pilot Study Of High-Order Aberrations With Aspheric Intraocular Lens (IOL) Models SN60WF And ZCB00
- ClinicalTrials.gov ID
- NCT01105585
- Acronym / sponsor ID
- M-09-003
- Conditions
- Cataracts
- Keywords
- Cataracts, aspheric, IOL, ocular aberrations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- First posted
- 16 Apr 2010 (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.
The purpose of this study was to prospectively compare high-order aberrations between eyes implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted with the Tecnis ZCB00 IOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZCB00 IOL | Experimental | Device: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOLTecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens (IOL) randomly assigned to one eye, with AcrySof Natural IQ (SN60WF) IOL in the fellow eye for contralateral implantation |
| SN60WF IOL | Active comparator | Device: AcrySof Natural IQ (SN60WF) IOLAcrySof Natural IQ (SN60WF) intraocular lens (IOL) randomly assigned to one eye, with Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens in the fellow eye for contralateral implantation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Requires bilateral extraction of cataracts by phacoemulsification followed by implantation of a posterior chamber intraocular lens;
- Confirmed absence of pre-existing conditions that could skew the results or present contraindications for the IQ intraocular lens (IOL) or the Tecnis ZCB00 IOL;
- <1 diopter corneal astigmatism preoperatively;
- Able to achieve 6.5 mm dilated pupil;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (10 listed)
- Chronic disease or illness;
- Irregular optical aberration;
- Amblyopia;
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
- Diabetic retinopathy;
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 |
|---|---|---|
| Tecnis 1-piece Aspheric Acrylic (ZCB00) IOLTecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient. | Device | ZCB00 IOL |
| AcrySof Natural IQ (SN60WF) IOLAcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient. | Device | SN60WF IOL |
Primary outcome
Total ocular high-order aberrations
Time frame: Month 1 postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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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 Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL and AcrySof Natural IQ (SN60WF) IOL in people with Cataracts, 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 5 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 29 Nov 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total ocular high-order aberrations (time frame: Month 1 postoperative). 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 29 Nov 2012.