CataractsNCT01214863
AcrySof Toric Clinical Results
An observational study of Cataracts and Astigmatism, run by Alcon Research at 1 site in United States.
Trial summary
This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataracts, Astigmatism
- What is being tested?
- T3, T4 and T5
- Type of treatment
- Medical device
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Apr 2008
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population chosen from physician's patients implanted with the AcrySof Toric intraocular lens (IOL)
Who may be able to join
- Diagnosed with cataracts; has astigmatism falling in range of AcrySof Toric lens as assessed by the AcrySof Toric calculator
Who cannot join
- Ocular comorbidities affecting visual outcome data,
- Prior refractive surgery,
- Irregular astigmatism
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: Clinical Results With the AcrySof Toric Intraocular Lens (IOL)
This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.
- Conditions
- Cataracts, Astigmatism
- Being tested
- T3, T4, T5
- Keywords
- Toric Intraocular Lens (IOL)
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3Device
Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T3
T4Device
Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T4
T5Device
Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T5
| Study group | Role | What they receive |
|---|---|---|
| T3 | Model SN60T3 assigned by AcrySof Toric calculator Receives: Device: T3 | |
| T4 | Model SN60T4 assigned by AcrySof Toric calculator Receives: Device: T4 | |
| T5 | Model SN60T5 assigned by AcrySof Toric calculator Receives: Device: T5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Measured: 1 day to 6 months
Secondary outcomes (1)
Postoperative refractive cylinder
Measured: 1day to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startAug 2007
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 144 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
- NCT01214863
- Sponsor's protocol ID
- M07-007
- Status last verified
- Oct 2010
- First submitted
- 7 Aug 2008
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Holladay JT, Wilcox RR, Koch DD, Wang L. Astigmatism analysis and reporting of surgically induced astigmatism and prediction error. J Cataract Refract Surg. 2022 Jul 1;48(7):799-812. doi: 10.1097/j.jcrs.0000000000000871.
PubMed 35749069
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results With the AcrySof Toric Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT01214863
- Acronym / sponsor ID
- M07-007
- Conditions
- Cataracts, Astigmatism
- Keywords
- Toric Intraocular Lens (IOL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- First posted
- 5 Oct 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.
This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T3 | – | Device: T3Model SN60T3 assigned by AcrySof Toric calculator |
| T4 | – | Device: T4Model SN60T4 assigned by AcrySof Toric calculator |
| T5 | – | Device: T5Model SN60T5 assigned by AcrySof Toric calculator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population chosen from physician's patients implanted with the AcrySof Toric intraocular lens (IOL)
Key inclusion criteria (1 listed)
- Diagnosed with cataracts; has astigmatism falling in range of AcrySof Toric lens as assessed by the AcrySof Toric calculator
Key exclusion criteria (3 listed)
- Ocular comorbidities affecting visual outcome data,
- Prior refractive surgery,
- Irregular astigmatism
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 |
|---|---|---|
| T3Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T3 | Device | T3 |
| T4Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T4 | Device | T4 |
| T5Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T5 | Device | T5 |
Primary outcome
Visual Acuity
Time frame: 1 day to 6 months
1 secondary outcome
Postoperative refractive cylinder
Time frame: 1day to 6 months
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 1 Oct 2012.
- Derived from this study: PubMed 35749069Holladay JT, Wilcox RR, Koch DD, Wang L. Astigmatism analysis and reporting of surgically induced astigmatism and prediction error. J Cataract Refract Surg. 2022 Jul 1;48(7):799-812. doi: 10.1097/j.jcrs.0000000000000871.
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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?
An observational study of Cataracts and Astigmatism, 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 1 inclusion and 3 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 1 Oct 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?
Visual Acuity (time frame: 1 day to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01214863, which also lists 1 linked publication.
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 1 Oct 2012.