CataractNCT05518227
Patient Satisfaction and Visual Outcomes After Bilateral PanOptix Implantation in Patients With Previous Multifocal Contact Lens
An observational study of Cataract, run by Vivid Laser Center at 1 site in Canada.
Trial summary
To evaluate spectacle independence and patient satisfaction and visual outcomes after bilateral PanOptix implantation in patients with previous multifocal contact lens experience. Read more about this study
- Who is it for?
- Any age
- 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
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jan 2023to 24 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, 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.
- Adult cataract patients undergoing uncomplicated cataract surgery with Clareon PanOptix IOL implantation (non-toric/toric).
- Visually significant cataracts bilaterally.
- History of successful soft multifocal contact lens use in the past (within ≤ last 5 years).
- Healthy ocular exam.
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- Gender: Males and Females.
- 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.
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.
- Previous monovision patients.
- Ocular comorbidity that might hamper post operative visual acuity (Uveitis, Keratoconus, Retinopathies, Glaucoma).
- Previous ocular or refractive surgery.
- Expected monocular post-op distance VA worse than 20/25 (Snellen) in either eye.
- Refractive lens exchange.
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- Angle kappa measurement in a single eye over 0.6 mm.
- Irregular corneal astigmatism or ectasia.
- Difficulties comprehending written or spoken English language.
- Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
- Severe/uncontrolled Ocular surface disease/Dry Eye Disease.
- Intraoperative complications during procedure.
- Visual expectations exceed outcomes.
- Strabismus (with or without amblyopia).
- 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 spectacle independence and patient satisfaction and visual outcomes after bilateral PanOptix implantation in patients with previous multifocal contact lens experience.
Read the detailed description
This study is a single-arm unmasked clinical evaluation study of patient satisfaction after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 week 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.
Satisfaction questionnaire
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.
Measured: 3 months postoperative
Secondary outcomes (8)
Binocular uncorrected distance visual acuity (6m)
Measured: 3 months postoperative
Binocular uncorrected intermediate visual acuity (60 cm)
Measured: 3 months postoperative
Binocular uncorrected near visual acuity (40 cm)
Measured: 3 months postoperative
Binocular corrected distance visual acuity (6m)
Measured: 3 months postoperative
Binocular distance corrected intermediate visual acuity (60 cm)
Measured: 3 months postoperative
Binocular distance corrected intermediate visual acuity (40 cm)
Measured: 3 months postoperative
Manifest refraction
Measured: 3 months postoperative
Spectacle independence
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.
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 start19 Jan 2023
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Why it stopped: recruitment slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivid Laser Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Ronald Baldassare, MD, Principal investigator, Vivid Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518227
- Sponsor's protocol ID
- RB-22-001
- Status last verified
- Mar 2025
- First submitted
- 24 Aug 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Visual Outcomes After Bilateral PanOptix Implantation in Patients With Previous Multifocal Contact Lens
- ClinicalTrials.gov ID
- NCT05518227
- Acronym / sponsor ID
- RB-22-001
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment slow
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vivid Laser CenterUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 26 Aug 2022 (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.
To evaluate spectacle independence and patient satisfaction and visual outcomes after bilateral PanOptix implantation in patients with previous multifocal contact lens experience.
Detailed description
This study is a single-arm unmasked clinical evaluation study of patient satisfaction after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 week 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
- Sex
- All
- Age groups
- Child, 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 (9 listed)
- Note: Ocular criteria must be met in both eyes.
- Adult cataract patients undergoing uncomplicated cataract surgery with Clareon PanOptix IOL implantation (non-toric/toric).
- Visually significant cataracts bilaterally.
- History of successful soft multifocal contact lens use in the past (within ≤ last 5 years).
- Healthy ocular exam.
Key exclusion criteria (16 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.
- Previous monovision patients.
- Ocular comorbidity that might hamper post operative visual acuity (Uveitis, Keratoconus, Retinopathies, Glaucoma).
- Previous ocular or refractive surgery.
- Expected monocular post-op distance VA worse than 20/25 (Snellen) in either eye.
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
Satisfaction questionnaire
Time frame: 3 months postoperative
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.
8 secondary outcomes
Binocular uncorrected distance visual acuity (6m)
Time frame: 3 months postoperative
Binocular uncorrected intermediate visual acuity (60 cm)
Time frame: 3 months postoperative
Binocular uncorrected near visual acuity (40 cm)
Time frame: 3 months postoperative
Binocular corrected distance visual acuity (6m)
Time frame: 3 months postoperative
Binocular distance corrected intermediate visual acuity (60 cm)
Time frame: 3 months postoperative
Binocular distance corrected intermediate visual acuity (40 cm)
Time frame: 3 months postoperative
Manifest refraction
Time frame: 3 months postoperative
Spectacle independence
Time frame: 3 months postoperative
Results and safety
The study was stopped early (reason given: recruitment slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- 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.
Ronald Baldassare, MD principal investigator
Vivid 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 Vivid Laser Center at 1 site in Canada.
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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 1 Apr 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 Canada. 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?
The study was stopped early (reason given: recruitment slow). Results are not available in the source record.
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?
Satisfaction questionnaire (time frame: 3 months 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 1 Apr 2025.