CataractsPhase 4NCT00732030
Low Cylinder Toric
A Phase 4 study testing Toric IOL (SN60T3) in people with Cataracts, run by Alcon Research at 1 site in United States.
Trial summary
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (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?
- Toric IOL (SN60T3)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Mar 2009
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Cataracts
- Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)
Who cannot join
- Preoperative ocular pathology
- Planned monovision
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: Evaluation of the Acrysof Toric Model SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.03 Diopters (D)
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).
- Conditions
- Cataracts
- Being tested
- Toric IOL (SN60T3)
- Keywords
- Toric IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toric IOL (SN60T3)Device
Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract.
| Study group | Role | What they receive |
|---|---|---|
| AcrySof Toric T3 | Experimental | Each enrolled eye receives AcrySof Toric Model SN60T3 Intraocular Lens (IOL) Receives: Device: Toric IOL (SN60T3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Measured: 6 months
Best Corrected Distance Visual Acuity
Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Measured: 6 Months
Residual Refractive Cylinder
Residual Refractive Cylinder at month 6 measured in diopters (D).
Measured: 6 Month
Secondary outcomes (1)
Patient Satisfaction Survey
Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionMar 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 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732030
- Sponsor's protocol ID
- M07-005
- Status last verified
- Mar 2010
- First submitted
- 7 Aug 2008
- Last updated
- 7 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acrysof Toric Model SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.03 Diopters (D)
- ClinicalTrials.gov ID
- NCT00732030
- Acronym / sponsor ID
- M07-005
- Conditions
- Cataracts
- Keywords
- Toric IOL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Mar 2009 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Posted 7 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AcrySof Toric T3 | Experimental | Device: Toric IOL (SN60T3)Each enrolled eye receives AcrySof Toric Model SN60T3 Intraocular Lens (IOL) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with Cataracts
- Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)
Key exclusion criteria (2 listed)
- Preoperative ocular pathology
- Planned monovision
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 |
|---|---|---|
| Toric IOL (SN60T3)Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract. | Device | AcrySof Toric T3 |
Primary outcome
Uncorrected Distance Visual Acuity
Time frame: 6 months
Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Best Corrected Distance Visual Acuity
Time frame: 6 Months
Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Residual Refractive Cylinder
Time frame: 6 Month
Residual Refractive Cylinder at month 6 measured in diopters (D).
1 secondary outcome
Patient Satisfaction Survey
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2010.
- 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 Phase 4 study testing Toric IOL (SN60T3) 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 2 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: finished, as of the sponsor's last update on 7 Apr 2010. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2010). 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?
Uncorrected Distance Visual Acuity (time frame: 6 months). The study lists 3 primary outcomes in all. 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 7 Apr 2010.