CataractsNCT01601665
Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9
An observational study of Cataracts and Astigmatism, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataracts, Astigmatism
- What is being tested?
- SN6AT6 Intraocular Lens, SN6AT7 Intraocular Lens and SN6AT8 Intraocular Lens
- Type of treatment
- Medical device
- How many people
- 477 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population will be selected from up to 80 clinical investigative sites.
Who may be able to join
- Diagnosed with bilateral cataracts and in the targeted astigmatism range.
- Planned cataract removal by phacoemulsification.
- Pupil size greater than or equal to 6 mm after dilation.
- Able to undergo second eye surgery within 30 days of first eye surgery.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Irregular corneal astigmatism.
- Any inflammation or swelling of the cornea.
- Any corneal abnormality other than regular corneal astigmatism.
- Previous corneal refractive surgery.
- Amblyopia.
- Diabetic retinopathy.
Show all 9Show fewer
- Uncontrolled glaucoma.
- Currently participating in another investigational drug or device study that may confound the results of this investigation.
- 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: Post Approval Study of the AcrySof® IQ Toric High Cylinder Power IOL Models SN6AT6-SN6AT9
The purpose of this study is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices.
Read the detailed description
In this prospective, non-randomized, unmasked study, subjects with pre-existing corneal astigmatism ≥2.57 diopters will choose to be implanted with either the AcrySof® IQ Toric High Cylinder Power IOL or the AcrySof® IQ Aspheric NATURAL monofocal IOL.
- Conditions
- Cataracts, Astigmatism
- Being tested
- SN6AT6 Intraocular Lens, SN6AT7 Intraocular Lens, SN6AT8 Intraocular Lens, SN6AT9 Intraocular Lens, SN60WF Intraocular Lens
- Keywords
- Intraocular lens, Cataracts, Astigmatism, Toric
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SN6AT6 Intraocular LensDevice
Also called AcrySof® IQ Toric Model SN6AT6
Acrylic intraocular lens with cylinder power at the IOL plane of 3.75 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
SN6AT7 Intraocular LensDevice
Also called AcrySof® IQ Toric Model SN6AT7
Acrylic intraocular lens with cylinder power at the IOL plane of 4.50 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
SN6AT8 Intraocular LensDevice
Also called AcrySof® IQ Toric Model SN6AT8
Acrylic intraocular lens with cylinder power at the IOL plane of 5.25 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
SN6AT9 Intraocular LensDevice
Also called AcrySof® IQ Toric Model SN6AT9
Acrylic intraocular lens with cylinder power at the IOL plane of 6.00 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
SN60WF Intraocular LensDevice
Also called AcrySof® IQ Aspheric NATURAL Model SN60WF
Acrylic aspheric monofocal intraocular lens. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
| Study group | Role | What they receive |
|---|---|---|
| Toric High Cylinder Power IOL | Toric high cylinder power intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation. Receives: Device: SN6AT6 Intraocular Lens; Device: SN6AT7 Intraocular Lens; Device: SN6AT8 Intraocular Lens; Device: SN6AT9 Intraocular Lens | |
| Monofocal IOL | Monofocal intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation. Receives: Device: SN60WF Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Severe Visual Distortions
As assessed by a Patient Reported Outcomes (PRO) questionnaire. Subjects will be categorized as experiencing a severe visual distortion if they indicate "severe" as a response to any of the three visual distortion-related questions on the questionnaire.
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 posted18 May 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2015
- Study completionJul 2015
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gina Calderon, CM, Surgical, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601665
- Sponsor's protocol ID
- C-11-020
- Status last verified
- Jul 2015
- First submitted
- 16 May 2012
- Last updated
- 4 Aug 2015
- 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 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study of the AcrySof® IQ Toric High Cylinder Power IOL Models SN6AT6-SN6AT9
- ClinicalTrials.gov ID
- NCT01601665
- Acronym / sponsor ID
- C-11-020
- Conditions
- Cataracts, Astigmatism
- Keywords
- Intraocular lens, Cataracts, Astigmatism, Toric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 May 2012 (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 is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices.
Detailed description
In this prospective, non-randomized, unmasked study, subjects with pre-existing corneal astigmatism ≥2.57 diopters will choose to be implanted with either the AcrySof® IQ Toric High Cylinder Power IOL or the AcrySof® IQ Aspheric NATURAL monofocal IOL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toric High Cylinder Power IOL | – | Device: SN6AT6 Intraocular Lens, Device: SN6AT7 Intraocular Lens, Device: SN6AT8 Intraocular Lens, Device: SN6AT9 Intraocular LensToric high cylinder power intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation. |
| Monofocal IOL | – | Device: SN60WF Intraocular LensMonofocal intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be selected from up to 80 clinical investigative sites.
Key inclusion criteria (5 listed)
- Diagnosed with bilateral cataracts and in the targeted astigmatism range.
- Planned cataract removal by phacoemulsification.
- Pupil size greater than or equal to 6 mm after dilation.
- Able to undergo second eye surgery within 30 days of first eye surgery.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (9 listed)
- Irregular corneal astigmatism.
- Any inflammation or swelling of the cornea.
- Any corneal abnormality other than regular corneal astigmatism.
- Previous corneal refractive surgery.
- Amblyopia.
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 |
|---|---|---|
| SN6AT6 Intraocular LensAlso: AcrySof® IQ Toric Model SN6AT6Acrylic intraocular lens with cylinder power at the IOL plane of 3.75 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject. | Device | Toric High Cylinder Power IOL |
| SN6AT7 Intraocular LensAlso: AcrySof® IQ Toric Model SN6AT7Acrylic intraocular lens with cylinder power at the IOL plane of 4.50 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject. | Device | Toric High Cylinder Power IOL |
| SN6AT8 Intraocular LensAlso: AcrySof® IQ Toric Model SN6AT8Acrylic intraocular lens with cylinder power at the IOL plane of 5.25 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject. | Device | Toric High Cylinder Power IOL |
| SN6AT9 Intraocular LensAlso: AcrySof® IQ Toric Model SN6AT9Acrylic intraocular lens with cylinder power at the IOL plane of 6.00 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject. | Device | Toric High Cylinder Power IOL |
| SN60WF Intraocular LensAlso: AcrySof® IQ Aspheric NATURAL Model SN60WFAcrylic aspheric monofocal intraocular lens. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject. | Device | Monofocal IOL |
Primary outcome
Rate of Severe Visual Distortions
Time frame: 6 months
As assessed by a Patient Reported Outcomes (PRO) questionnaire. Subjects will be categorized as experiencing a severe visual distortion if they indicate "severe" as a response to any of the three visual distortion-related questions on the questionnaire.
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 4 Aug 2015.
- 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.
Gina Calderon, CM, Surgical study director
Alcon Research
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 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: finished, as of the sponsor's last update on 4 Aug 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.
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?
Rate of Severe Visual Distortions (time frame: 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 NCT01601665, 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 4 Aug 2015.