AphakiaNCT07484191
Contralateral Claims Study of Clareon Vivity Pro
A study testing Clareon Vivity Pro IOL, Clareon Vivity IOL and TECNIS PureSee IOL in people with Aphakia and Presbyopia, run by Alcon Research at 7 sites in Australia.
Trial summary
The purpose of this study is to test new versions of Clareon Vivity Pro intraocular lenses (IOLs) by comparing them to currently marketed IOLs. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aphakia, Presbyopia
- What is being tested?
- Clareon Vivity Pro IOL, Clareon Vivity IOL and TECNIS PureSee IOL
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 7 sitesAustralia
- Study dates
- 28 Apr 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Cataracts in both eyes.
- Preoperative corneal astigmatism of less than 1.00 diopter (D) in each eye.
- Potential postoperative best corrected visual acuity (BCDVA) of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Desires monovision correction.
- Predicted post-operative residual astigmatism of more than 1D in either eye.
- Any ocular or systemic co-morbidity that, in the investigator's medical opinion, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
iVision Clinic
Campsie, New South Wales, 2194
Eye Surgery Associates - East Melbourne
East Melbourne, Victoria, 3002
Peninsula Eye Center
Mornington, Victoria, 3931
Vision Eye Institute - Chatswood
Sydney, New South Wales, 2067
Personaleyes Parramatta
Sydney, New South Wales, 2150
Wollongong Eye Specialists
Wollongong, New South Wales, 2500
Focus Vision
Woolloongabba, Queensland, 4102
About this study
The purpose of this study is to test new versions of Clareon Vivity Pro intraocular lenses (IOLs) by comparing them to currently marketed IOLs.
Read the detailed description
Two sub-studies will be conducted. In Sub-Study B, Clareon Vivity Pro will be compared to Clareon Vivity. In Sub-Study C, Clareon Vivity Pro will be compared to TECNIS PureSee.
This study will be conducted in Australia.
- Conditions
- Aphakia, Presbyopia
- Being tested
- Clareon Vivity Pro IOL, Clareon Vivity IOL, TECNIS PureSee IOL, Cataract Surgery
- Keywords
- Cataract, Eye Surgery, Intermediate Vision
- Medical subject headings
- Aphakia, Presbyopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon Vivity Pro IOLDevice
Investigational UV-absorbing, blue-light filtering (BLF), foldable IOL that provides an extended range of vision from distance to near without increasing the incidence of visual disturbances.
IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.
Clareon Vivity IOLDevice
Currently marketed UV-absorbing, BLF, foldable IOL that provides an extended range of vision from distance to functional near without increasing the incidence of visual disturbances.
IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.
TECNIS PureSee IOLDevice
Currently marketed UV absorbing, violet-light filtering IOL for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia.
IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.
Cataract SurgeryProcedure or surgery
Removal of the cloudy lens, followed by implantation of the IOL
| Study group | Role | What they receive |
|---|---|---|
| Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B) | Other | Clareon Vivity Pro IOL implanted in one eye, with Clareon Vivity IOL in the fellow eye, as randomized Receives: Device: Clareon Vivity Pro IOL; Device: Clareon Vivity IOL; Procedure: Cataract Surgery |
| Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C) | Other | Clareon Vivity Pro IOL implanted in one eye, with TECNIS PureSee IOL in the fellow eye, as randomized Receives: Device: Clareon Vivity Pro IOL; Device: TECNIS PureSee IOL; Procedure: Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean monocular photopic distance-corrected intermediate visual acuity (DCIVA)
Visual acuity (VA) will be assessed for each eye individually (monocular) with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA will be measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity.
Measured: Month 1 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start28 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this contralateral study, subjects will receive Clareon Vivity Pro IOL in one eye and either Clareon Vivity IOL or TECNIS PureSee IOL in the other eye.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 165 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
- NCT07484191
- Sponsor's protocol ID
- ILI287-C001
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contralateral Claims Study of Clareon Vivity Pro
- ClinicalTrials.gov ID
- NCT07484191
- Acronym / sponsor ID
- ILI287-C001
- Conditions
- Aphakia, Presbyopia
- Keywords
- Cataract, Eye Surgery, Intermediate Vision
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- 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 test new versions of Clareon Vivity Pro intraocular lenses (IOLs) by comparing them to currently marketed IOLs.
Detailed description
Two sub-studies will be conducted. In Sub-Study B, Clareon Vivity Pro will be compared to Clareon Vivity. In Sub-Study C, Clareon Vivity Pro will be compared to TECNIS PureSee.
This study will be conducted in Australia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In this contralateral study, subjects will receive Clareon Vivity Pro IOL in one eye and either Clareon Vivity IOL or TECNIS PureSee IOL in the other eye.
| Arm | Type | Receives |
|---|---|---|
| Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B) | Other | Device: Clareon Vivity Pro IOL, Device: Clareon Vivity IOL, Procedure: Cataract SurgeryClareon Vivity Pro IOL implanted in one eye, with Clareon Vivity IOL in the fellow eye, as randomized |
| Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C) | Other | Device: Clareon Vivity Pro IOL, Device: TECNIS PureSee IOL, Procedure: Cataract SurgeryClareon Vivity Pro IOL implanted in one eye, with TECNIS PureSee IOL in the fellow eye, as randomized |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cataracts in both eyes.
- Preoperative corneal astigmatism of less than 1.00 diopter (D) in each eye.
- Potential postoperative best corrected visual acuity (BCDVA) of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Desires monovision correction.
- Predicted post-operative residual astigmatism of more than 1D in either eye.
- Any ocular or systemic co-morbidity that, in the investigator's medical opinion, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject.
- 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 |
|---|---|---|
| Clareon Vivity Pro IOLInvestigational UV-absorbing, blue-light filtering (BLF), foldable IOL that provides an extended range of vision from distance to near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject. | Device | Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B), Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C) |
| Clareon Vivity IOLCurrently marketed UV-absorbing, BLF, foldable IOL that provides an extended range of vision from distance to functional near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject. | Device | Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B) |
| TECNIS PureSee IOLCurrently marketed UV absorbing, violet-light filtering IOL for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject. | Device | Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C) |
| Cataract SurgeryRemoval of the cloudy lens, followed by implantation of the IOL | Procedure or surgery | Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B), Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C) |
Primary outcome
Mean monocular photopic distance-corrected intermediate visual acuity (DCIVA)
Time frame: Month 1 postoperative
Visual acuity (VA) will be assessed for each eye individually (monocular) with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA will be measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- EducationalLink provided by the sponsor.
- 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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clareon Vivity Pro IOL, Clareon Vivity IOL and TECNIS PureSee IOL in people with Aphakia and Presbyopia, run by Alcon Research at 7 sites in Australia.
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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) (time frame: Month 1 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 13 Oct 2026.