CataractNCT03350503
AcrySof IQ Toric A-Code Post-Market Clinical Study
A study testing AcrySof IQ Toric A-code IOL and Cataract surgery in people with Cataract and Astigmatism, run by Alcon Research at 4 sites in Japan.
Trial summary
The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- AcrySof IQ Toric A-code IOL and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 4 sitesJapan
- Study dates
- 30 Jan 2018to 17 Dec 2021
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cataracts with planned cataract removal by phacoemulsification
- Calculated lens power within the available range
- Able to sign informed consent and complete all study visits
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Eye conditions as specified in the protocol
- Uncontrolled glaucoma
- Pregnancy, current or planned
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Alcon Investigative Site
Hakodate, Hokkaido, 040-0053
Alcon Investigative Site
Hiroshima, Hiroshima, 733-0842
Alcon Investigative Site
Miyakonojō, Miyazaki, 885-0051
Alcon Investigative Site
Saga, Saga-ken, 840-0831
About this study
The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.
Read the detailed description
Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.
- Conditions
- Cataract, Astigmatism
- Being tested
- AcrySof IQ Toric A-code IOL, Cataract surgery
- Keywords
- phacoemulsification, intraocular lens, vision, 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.
AcrySof IQ Toric A-code IOLDevice
Also called Models SN6AT3, SN6AT4, SN6AT5
Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient
Cataract surgeryProcedure or surgery
Removal of cataractous lens and implantation of IOL
| Study group | Role | What they receive |
|---|---|---|
| Acrysof IQ Toric A-code IOL | Experimental | IOL implanted during cataract surgery Receives: Device: AcrySof IQ Toric A-code IOL; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.
Measured: Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start30 Jan 2018
- Primary completion23 May 2019
- Study completion17 Dec 2021
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Expert Clinical Project Lead, CDMA Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350503
- Sponsor's protocol ID
- ILV814-P001
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2017
- Last updated
- 28 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcrySof IQ Toric A-Code Post-Market Clinical Study
- ClinicalTrials.gov ID
- NCT03350503
- Acronym / sponsor ID
- ILV814-P001
- Conditions
- Cataract, Astigmatism
- Keywords
- phacoemulsification, intraocular lens, vision, toric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Posted 12 May 2020
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 clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.
Detailed description
Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acrysof IQ Toric A-code IOL | Experimental | Device: AcrySof IQ Toric A-code IOL, Procedure: Cataract surgeryIOL implanted during cataract surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of cataracts with planned cataract removal by phacoemulsification
- Calculated lens power within the available range
- Able to sign informed consent and complete all study visits
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Eye conditions as specified in the protocol
- Uncontrolled glaucoma
- Pregnancy, current or planned
- Other protocol-defined exclusion criteria may apply.
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 Toric A-code IOLAlso: Models SN6AT3, SN6AT4, SN6AT5Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient | Device | Acrysof IQ Toric A-code IOL |
| Cataract surgeryRemoval of cataractous lens and implantation of IOL | Procedure or surgery | Acrysof IQ Toric A-code IOL |
Primary outcome
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
Time frame: Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)
IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Expert Clinical Project Lead, CDMA Surgical study director
Alcon Research, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcrySof IQ Toric A-code IOL and Cataract surgery in people with Cataract and Astigmatism, run by Alcon Research at 4 sites in Japan.
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 4 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 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 12 May 2020). 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?
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4) (time frame: Visit 00 (Day 0 operative), Visit 4 (Day 120-180 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 28 Dec 2022.