CataractNCT05518539
Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
An observational study of Cataract, run by Newsom Eye & Laser Center at 1 site in United States.
Trial summary
To evaluate visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens (IOL) targeted for emmetropia. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- The Clareon™ PanOptix™ Trifocal (toric and non-toric models)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to 14 Jun 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 40 years and older
- All sexes
- Adult, Older adult
Study population: Eligible participants will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for near, intermediate and distance vision, and who are considered appropriate candidates for trifocal lens implantation.
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria:
- Note: Ocular criteria must be met in both eyes.
- Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a trifocal IOL
- Meet the requirements for on-label implantation of the trifocal IOL
- Gender: Males and Females.
- Age: 40 or older.
Show all 11Show fewer
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and other study procedures.
- Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract).
- Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.
- All eyes will be in the range of availability for Clareon PanOptix IOL and Clareon PanOptix Toric IOL. For cylinder below the Toric IOL indication (T3), an LRI will be used during surgery.
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Patients with any corneal pathology (including corneal dystrophies, scaring, severe dry eye syndrome, irregular astigmatism, HOA) limiting or affecting visual potential.
- Patients with previous corneal refractive surgery.
- Patients with pre-existing ocular pathology, including maculopathy, ARMD, ERM, prior RD, and glaucoma limiting or affecting visual potential.
- Subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
- Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens (IOL) targeted for emmetropia.
Read the detailed description
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
- Conditions
- Cataract
- Being tested
- The Clareon™ PanOptix™ Trifocal (toric and non-toric models)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Clareon™ PanOptix™ Trifocal (toric and non-toric models)Device
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
| Study group | Role | What they receive |
|---|---|---|
| The Clareon™ PanOptix™ Trifocal (toric and non-toric models) | Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) Receives: Device: The Clareon™ PanOptix™ Trifocal (toric and non-toric models) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Distance-corrected Near (40 cm) Visual Acuity
Measured: 1 month postoperatively
Binocular Distance-corrected Near (40 cm) Visual Acuity
Measured: 3 months postoperatively
Secondary outcomes (8)
Binocular Uncorrected Distance (6 m) Visual Acuity
Measured: 1 and 3 months postoperative
Binocular Uncorrected Intermediate (60 cm) Visual Acuity
Measured: 1 and 3 months postoperative
Binocular Uncorrected Near (40 cm) Visual Acuity
Measured: 1 and 3 months postoperative
Binocular Corrected Corrected Distance (6 m) Visual Acuity
Measured: 1 and 3 months postoperative
Binocular Distance-corrected Intermediate (60 cm) Visual Acuity
Measured: 1 and 3 months postoperative
Manifest Refraction
spherical equivalent refraction and astigmatism less than or equal to 0.5 D.
Measured: 3 months postoperative
Satisfaction Questionnaire
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.
Measured: 3 months postoperative
Visual Disturbances Questionnaire
Questionnaire for Visual Disturbances (QUVID).
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start8 Sep 2022
- Primary completion14 Jun 2024
- Study completion14 Jun 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newsom Eye & Laser Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Thomas H Newsom, MD, Principal investigator, Newsom Eye & Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518539
- Sponsor's protocol ID
- THN-22-001
- Status last verified
- Jun 2025
- First submitted
- 24 Aug 2022
- Last updated
- 18 Jul 2025
- 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
- ClinicalTrials.gov ID
- NCT05518539
- Acronym / sponsor ID
- THN-22-001
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Newsom Eye & Laser CenterUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Posted 18 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens (IOL) targeted for emmetropia.
Detailed description
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Clareon™ PanOptix™ Trifocal (toric and non-toric models) | – | Device: The Clareon™ PanOptix™ Trifocal (toric and non-toric models)Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for near, intermediate and distance vision, and who are considered appropriate candidates for trifocal lens implantation.
Key inclusion criteria (11 listed)
- Note: Ocular criteria must be met in both eyes.
- Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a trifocal IOL
- Meet the requirements for on-label implantation of the trifocal IOL
- Gender: Males and Females.
- Age: 40 or older.
Key exclusion criteria (8 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Patients with any corneal pathology (including corneal dystrophies, scaring, severe dry eye syndrome, irregular astigmatism, HOA) limiting or affecting visual potential.
- Patients with previous corneal refractive surgery.
- Patients with pre-existing ocular pathology, including maculopathy, ARMD, ERM, prior RD, and glaucoma limiting or affecting visual potential.
- Subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
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 |
|---|---|---|
| The Clareon™ PanOptix™ Trifocal (toric and non-toric models)Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) | Device | The Clareon™ PanOptix™ Trifocal (toric and non-toric models) |
Primary outcome
Binocular Distance-corrected Near (40 cm) Visual Acuity
Time frame: 1 month postoperatively
Binocular Distance-corrected Near (40 cm) Visual Acuity
Time frame: 3 months postoperatively
8 secondary outcomes
Binocular Uncorrected Distance (6 m) Visual Acuity
Time frame: 1 and 3 months postoperative
Binocular Uncorrected Intermediate (60 cm) Visual Acuity
Time frame: 1 and 3 months postoperative
Binocular Uncorrected Near (40 cm) Visual Acuity
Time frame: 1 and 3 months postoperative
Binocular Corrected Corrected Distance (6 m) Visual Acuity
Time frame: 1 and 3 months postoperative
Binocular Distance-corrected Intermediate (60 cm) Visual Acuity
Time frame: 1 and 3 months postoperative
Manifest Refraction
Time frame: 3 months postoperative
Satisfaction Questionnaire
Time frame: 3 months postoperative
Visual Disturbances Questionnaire
Time frame: 3 months postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- 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.
Thomas H Newsom, MD principal investigator
Newsom Eye & Laser Center
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, run by Newsom Eye & Laser Center 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 11 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 18 Jul 2025. 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 18 Jul 2025). 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?
Binocular Distance-corrected Near (40 cm) Visual Acuity (time frame: 1 month postoperatively). The study lists 2 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 18 Jul 2025.