CataractPhase 4NCT01074606
Visual Function After Implantation of AcrySof® Toric Lens
A Phase 4 study testing AcrySof Toric Intraocular Lens in people with Cataract, run by Alcon Research at 1 site in Taiwan.
Trial summary
The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- AcrySof Toric Intraocular Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Mar 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
- Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
- All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
- For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.
Who cannot join
- Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
- AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.
- Conditions
- Cataract
- Being tested
- AcrySof Toric Intraocular Lens
- Keywords
- 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 Toric Intraocular LensDevice
Implantation of the AcrySof Toric Intraocular Lens (IOL)
| Study group | Role | What they receive |
|---|---|---|
| Toric | Experimental | AcrySof Toric Intraocular Lens (IOL) Receives: Device: AcrySof Toric Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Refractive Cylinder
Measured: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
Secondary outcomes (2)
Uncorrected distance visual acuity (UCDVA)
Measured: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
Best corrected distance visual acuity (BDCVA)
Measured: Pre-operative, 1 month postoperative, 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2011
Why it stopped: The study was terminated based on a business decision.
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 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
- NCT01074606
- Sponsor's protocol ID
- MT-0902
- Status last verified
- Aug 2011
- First submitted
- 23 Feb 2010
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Function After Implantation of AcrySof® Toric Lens
- ClinicalTrials.gov ID
- NCT01074606
- Acronym / sponsor ID
- MT-0902
- Conditions
- Cataract
- Keywords
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated based on a business decision.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- First posted
- 24 Feb 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 objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toric | Experimental | Device: AcrySof Toric Intraocular LensAcrySof Toric Intraocular Lens (IOL) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
- Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
- All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
- For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.
Key exclusion criteria (2 listed)
- Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
- AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.
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 Toric Intraocular LensImplantation of the AcrySof Toric Intraocular Lens (IOL) | Device | Toric |
Primary outcome
Postoperative Refractive Cylinder
Time frame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
2 secondary outcomes
Uncorrected distance visual acuity (UCDVA)
Time frame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
Best corrected distance visual acuity (BDCVA)
Time frame: Pre-operative, 1 month postoperative, 3 months postoperative
Results and safety
The study was stopped early (reason given: The study was terminated based on a business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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 Phase 4 study testing AcrySof Toric Intraocular Lens in people with Cataract, run by Alcon Research at 1 site in Taiwan.
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 2 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: stopped early, as of the sponsor's last update on 19 Sep 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 Taiwan. 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 stopped early (reason given: The study was terminated based on a business decision.). Results are not available in the source record.
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?
Postoperative Refractive Cylinder (time frame: Pre-Operative Day, 1 Month Postoperative, 3 Month 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 19 Sep 2012.