AphakiaNCT04098367
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
A study testing VIVITY, SYMFONY and AT LARA in people with Aphakia, run by Alcon Research at 12 sites in 2 countries.
Trial summary
The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aphakia
- What is being tested?
- VIVITY, SYMFONY and AT LARA
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 18 Nov 2019to 22 Jul 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned cataract removal in both eyes.
- Willing and able to complete all required postoperative visits.
- Able to understand, read and write English and willing to sign an approved statement of informed consent.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.
- Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.
- Ocular trauma or ocular surface disease that would affect study measurements.
- Patients who desire monovision correction.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Australia9 sites
Alcon Investigator 8047
Charlestown, New South Wales, 2290
Alcon Investigator 8052
Eastwood, South Australia, 5063
Alcon Investigator 8010
Essendon, Victoria, 3040
Alcon Investigator 7813
Footscray, Victoria, 3011
Alcon Investigator 7130
Hobart, Tasmania, 7000
Alcon Investigator 1702
Mornington, Victoria, 3931
Alcon Investigator 8051
Murdoch, Western Australia, 6150
Alcon Investigator 6667
Sydney, New South Wales, 2067
Alcon Investigator 7678
Sydney, New South Wales, 2150
New Zealand3 sites
Alcon Investigator 8056
Auckland, 1050
Alcon Investigator 8050
Auckland
Alcon Investigator 3656
Wellington, 6011
About this study
Official title: A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs
The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.
Read the detailed description
A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.
- Conditions
- Aphakia
- Being tested
- VIVITY, SYMFONY, AT LARA, Cataract surgery
- Keywords
- Cataracts, Extracapsular cataract extraction, IOL, Extended depth of focus, Visual disturbances, Presbyopia, Intraocular lens
- Medical subject headings
- Aphakia, Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVITYDevice
Also called AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015
Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction
SYMFONYDevice
Also called TECNIS Symfony® Extended Range of Vision IOL Model ZXR00
Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed
AT LARADevice
Also called AT LARA® extended depth of focus IOL Model 829MP
Extended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction
Cataract surgeryProcedure or surgery
Cataract removal by routine small incision surgery
| Study group | Role | What they receive |
|---|---|---|
| VIVITY | Experimental | VIVITY IOL implanted in the eye during cataract surgery Receives: Device: VIVITY; Procedure: Cataract surgery |
| SYMFONY | Active comparator | SYMFONY IOL implanted in the eye during cataract surgery Receives: Device: SYMFONY; Procedure: Cataract surgery |
| AT LARA | Active comparator | AT LARA implanted in the eye during cataract surgery Receives: Device: AT LARA; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
Measured: Month 3 postoperative (Day 120-180 from second eye surgery)
Secondary outcomes (2)
Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)
Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
Measured: Month 3 postoperative (Day 120-180 from second eye surgery)
Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)
A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
Measured: Month 3 postoperative (Day 120-180 from second eye surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start18 Nov 2019
- Primary completion3 May 2021
- Study completion22 Jul 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 AphakiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098367
- Sponsor's protocol ID
- ILI875-P001
- Status last verified
- May 2022
- First submitted
- 19 Sep 2019
- Last updated
- 4 May 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 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs
- ClinicalTrials.gov ID
- NCT04098367
- Acronym / sponsor ID
- ILI875-P001
- Conditions
- Aphakia
- Keywords
- Cataracts, Extracapsular cataract extraction, IOL, Extended depth of focus, Visual disturbances, Presbyopia, Intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Posted 4 May 2022
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 compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.
Detailed description
A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VIVITY | Experimental | Device: VIVITY, Procedure: Cataract surgeryVIVITY IOL implanted in the eye during cataract surgery |
| SYMFONY | Active comparator | Device: SYMFONY, Procedure: Cataract surgerySYMFONY IOL implanted in the eye during cataract surgery |
| AT LARA | Active comparator | Device: AT LARA, Procedure: Cataract surgeryAT LARA implanted in the eye during cataract surgery |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned cataract removal in both eyes.
- Willing and able to complete all required postoperative visits.
- Able to understand, read and write English and willing to sign an approved statement of informed consent.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.
- Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.
- Ocular trauma or ocular surface disease that would affect study measurements.
- Patients who desire monovision correction.
- Other protocol-specified 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 |
|---|---|---|
| VIVITYAlso: AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction | Device | VIVITY |
| SYMFONYAlso: TECNIS Symfony® Extended Range of Vision IOL Model ZXR00Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed | Device | SYMFONY |
| AT LARAAlso: AT LARA® extended depth of focus IOL Model 829MPExtended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction | Device | AT LARA |
| Cataract surgeryCataract removal by routine small incision surgery | Procedure or surgery | AT LARA, SYMFONY, VIVITY |
Primary outcome
Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
Time frame: Month 3 postoperative (Day 120-180 from second eye surgery)
QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
2 secondary outcomes
Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)
Time frame: Month 3 postoperative (Day 120-180 from second eye surgery)
Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)
Time frame: Month 3 postoperative (Day 120-180 from second eye surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 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.
Clinical Trial Lead, Surgical study director
Alcon Research, LLC
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIVITY, SYMFONY and AT LARA in people with Aphakia, run by Alcon Research at 12 sites in 2 countries.
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 5 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 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, New Zealand. 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 4 May 2022). 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 Subjects Not Bothered at All by Halos (QUVID Question 2.3) (time frame: Month 3 postoperative (Day 120-180 from second eye surgery)). 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 4 May 2022.