CataractPhase 4NCT00760058
Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
A Phase 4 study testing AcrySof® IQ IOL, Tecnis® Aspheric intraocular lens and Akreos® MI60 intraocular lens in people with Cataract, run by Alcon Research at 1 site in United States.
Trial summary
The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- AcrySof® IQ IOL, Tecnis® Aspheric intraocular lens and Akreos® MI60 intraocular lens
- 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
- Jun 2008to Dec 2010
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged 50 and over.
- Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
- Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
- Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
- Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.
Who cannot join
- Subjects who have previously had corneal surgery.
- Subjects who have potential visual acuity which is < 6/12 due to other ocular pathology
- Subjects with corneal pathology.
- Subjects with astigmatism of greater than 1D.
- Subjects diagnosed with glaucoma.
- Subjects diagnosed with diabetes.
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- Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment
- Subjects with a know history of poor compliance
- Subjects with planned adjunctive surgery
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.
- Conditions
- Cataract
- Being tested
- AcrySof® IQ IOL, Tecnis® Aspheric intraocular lens, Akreos® MI60 intraocular lens
- Keywords
- cataract, intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof® IQ IOLDevice
Replacement of natural crystalline lens in cataract surgery
Tecnis® Aspheric intraocular lensDevice
Replacement of natural crystalline lens in cataract surgery
Akreos® MI60 intraocular lensDevice
Replacement of natural crystalline lens in cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AcrySof® IQ intraocular lens Receives: Device: AcrySof® IQ IOL |
| 2 | Active comparator | Tecnis® Aspheric intraocular lens Receives: Device: Tecnis® Aspheric intraocular lens |
| 3 | Active comparator | Akreos® MI60 intraocular lens Receives: Device: Akreos® MI60 intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast sensitivity
Measured: 3 months
Secondary outcomes (1)
Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.
Measured: 3 months
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 startJun 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Enrollment not initiated for study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- 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
- NCT00760058
- Sponsor's protocol ID
- AUS-06-02
- Status last verified
- Mar 2010
- First submitted
- 24 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
- Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
- ClinicalTrials.gov ID
- NCT00760058
- Acronym / sponsor ID
- AUS-06-02
- Conditions
- Cataract
- Keywords
- cataract, intraocular lens
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment not initiated for study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- 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.
The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: AcrySof® IQ IOLAcrySof® IQ intraocular lens |
| 2 | Active comparator | Device: Tecnis® Aspheric intraocular lensTecnis® Aspheric intraocular lens |
| 3 | Active comparator | Device: Akreos® MI60 intraocular lensAkreos® MI60 intraocular lens |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects, aged 50 and over.
- Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
- Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
- Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
- Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.
Key exclusion criteria (9 listed)
- Subjects who have previously had corneal surgery.
- Subjects who have potential visual acuity which is < 6/12 due to other ocular pathology
- Subjects with corneal pathology.
- Subjects with astigmatism of greater than 1D.
- Subjects diagnosed with glaucoma.
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® IQ IOLReplacement of natural crystalline lens in cataract surgery | Device | 1 |
| Tecnis® Aspheric intraocular lensReplacement of natural crystalline lens in cataract surgery | Device | 2 |
| Akreos® MI60 intraocular lensReplacement of natural crystalline lens in cataract surgery | Device | 3 |
Primary outcome
Contrast sensitivity
Time frame: 3 months
1 secondary outcome
Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.
Time frame: 3 months
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® IQ IOL, Tecnis® Aspheric intraocular lens and Akreos® MI60 intraocular lens 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 5 inclusion and 9 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?
Contrast sensitivity (time frame: 3 months). 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.