CataractNCT05827133
Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance With Clareon® Vivity® IOL Implantation
An observational study of Cataract and Lenses, Intraocular, run by East Coast Institute for Research at 1 site in United States.
Trial summary
The goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation. The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision? Participants implanted with Clareon®… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Lenses, Intraocular
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to 23 Jul 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include approximately 100 adult participants (200 eyes) who have previously been implanted with Clareon® Vivity® and Vivity® Toric intraocular lenses (IOLs).
Who may be able to join
- Age ≥ 18 years
- History of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric intraocular lens (IOL) implantation with manifest refraction spherical equivalent (MRSE) within ±1.00 D
- Willing to undergo an eye exam with pupil dilation
Who cannot join
- Moderate to severe posterior capsule opacification (2+ or more)
- Yttrium aluminum garnet (YAG) laser capsulotomy within 1 month prior to enrollment
- Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) within the one year prior to IOL implantation or any time after IOL implantation
- Any previous ocular surgery (excluding YAG, LASIK, PRK)
- Clinically significant ocular pathology; severe diabetic retinopathy, age-related macular degeneration (AMD), glaucoma, severe dry eye, irregular astigmatism, zonular weakness, pseudoexfoliation, ocular trauma
- Any additional procedure(s) at the same time as the Vivity implantation including but not limited to microinvasive glaucoma surgery (MIGS)
- Women who are pregnant at the time of screening (based on self-reported history)
- Medical or other problems which in the opinion of the investigator will render study participation unsafe
Trial locations and contacts
1 site in 1 country.
United States1 site
East Coast Institute for Research
Jacksonville, Florida, 32216
About this study
Official title: A Non-Interventional Study to Evaluate the Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance in Patients Who Have Undergone Clareon® Vivity® IOL Implantation
The goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation.
The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision?
Read more
Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following:
- consent to participate in the study
- allow researchers to access their personal medical records
- undergo a series of tests to assess the position of their IOLs and quality of vision
Researchers will assess participant examination results to determine whether an association exists between IOL movement and patient quality of vision.
Read the detailed description
This is a non-interventional, single-center, multi-surgeon, observational study to evaluate the effect of intraocular lens (IOL) centration and tilt on visual performance in patients who have undergone Clareon® Vivity® IOL implantation. The study population will include individuals implanted with Clareon® Vivity® and Vivity® Toric IOLs. IOL implantations reviewed will range from the earliest performed (May 2022) onward, until 100 implanted patients (200 eyes) are enrolled. Potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination.
- Conditions
- Cataract, Lenses, Intraocular
- Being tested
- No intervention
- Keywords
- Extended Depth of Focus Lens, Toric Lens, Decentration, Tilt, Clareon Vivity, Clareon Vivity Toric
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDVA100
The mean between Monocular best-corrected distance visual acuity (CDVA100) (logMAR) (High Contrast - 100%).
Measured: 1 Day
IOL Decentration
The mean value and standard deviation of IOL decentration.
Measured: 1 day
IOL Tilt
The mean value and standard deviation of IOL tilt.
Measured: 1 day
Secondary outcomes (4)
UCDVA100
The mean between Uncorrected Distance Visual Acuity (UCDVA100) (logMAR) (High Contrast - 100%)
Measured: 1 day
UCIVA100
The mean between Uncorrected Intermediate Visual Acuity (UCIVA100) (logMAR) (High Contrast - 100%).
Measured: 1 day
DCIVA100
The mean between Distance Corrected Intermediate Visual Acuity (100%) (DCIVA100) (logMAR) (High Contrast - 100%).
Measured: 1 day
MRSE
The mean between Manifest Refraction Spherical Equivalent (MRSE) (D).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start10 Jul 2023
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Coast Institute for Research
- Sponsor type
- Research network
- Collaborators
- Alcon Research, Florida Eye Specialists
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827133
- Sponsor's protocol ID
- ECIR-Alcon-01
- Status last verified
- May 2026
- First submitted
- 11 Apr 2023
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study to Evaluate the Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance in Patients Who Have Undergone Clareon® Vivity® IOL Implantation
- ClinicalTrials.gov ID
- NCT05827133
- Acronym / sponsor ID
- ECIR-Alcon-01
- Conditions
- Cataract, Lenses, Intraocular
- Keywords
- Extended Depth of Focus Lens, Toric Lens, Decentration, Tilt, Clareon Vivity, Clareon Vivity Toric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- East Coast Institute for ResearchResearch network
- Collaborators
- Alcon Research, Florida Eye Specialists
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Posted 10 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation.
The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision?
Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following:
- consent to participate in the study
- allow researchers to access their personal medical records
- undergo a series of tests to assess the position of their IOLs and quality of vision
Researchers will assess participant examination results to determine whether an association exists between IOL movement and patient quality of vision.
Detailed description
This is a non-interventional, single-center, multi-surgeon, observational study to evaluate the effect of intraocular lens (IOL) centration and tilt on visual performance in patients who have undergone Clareon® Vivity® IOL implantation. The study population will include individuals implanted with Clareon® Vivity® and Vivity® Toric IOLs. IOL implantations reviewed will range from the earliest performed (May 2022) onward, until 100 implanted patients (200 eyes) are enrolled. Potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | – | Other: No interventionIndividuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include approximately 100 adult participants (200 eyes) who have previously been implanted with Clareon® Vivity® and Vivity® Toric intraocular lenses (IOLs).
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- History of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric intraocular lens (IOL) implantation with manifest refraction spherical equivalent (MRSE) within ±1.00 D
- Willing to undergo an eye exam with pupil dilation
Key exclusion criteria (8 listed)
- Moderate to severe posterior capsule opacification (2+ or more)
- Yttrium aluminum garnet (YAG) laser capsulotomy within 1 month prior to enrollment
- Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) within the one year prior to IOL implantation or any time after IOL implantation
- Any previous ocular surgery (excluding YAG, LASIK, PRK)
- Clinically significant ocular pathology; severe diabetic retinopathy, age-related macular degeneration (AMD), glaucoma, severe dry eye, irregular astigmatism, zonular weakness, pseudoexfoliation, ocular trauma
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 |
|---|---|---|
| No interventionNo intervention | Other | Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) |
Primary outcome
CDVA100
Time frame: 1 Day
The mean between Monocular best-corrected distance visual acuity (CDVA100) (logMAR) (High Contrast - 100%).
IOL Decentration
Time frame: 1 day
The mean value and standard deviation of IOL decentration.
IOL Tilt
Time frame: 1 day
The mean value and standard deviation of IOL tilt.
4 secondary outcomes
UCDVA100
Time frame: 1 day
UCIVA100
Time frame: 1 day
DCIVA100
Time frame: 1 day
MRSE
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- 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.
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?
An observational study of Cataract and Lenses, Intraocular, run by East Coast Institute for 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 3 inclusion and 8 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 10 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2026). 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?
CDVA100 (time frame: 1 Day). 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 10 Jul 2026.