CataractNCT05488769
Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material
An observational study of Cataract, run by Thomas Nagy at 1 site in Canada.
Trial summary
The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- Clareon Vivity extended depth of focus (EDOF) intraocular lens
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2022to 29 Nov 2022
- 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 test subjects will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for intermediate and distance vision, and who are considered appropriate candidates for EDOF lens implantation.
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
- Visually significant age-related cataracts bilaterally.
- Best monocular Corrected distance Visual Acuity predicted to be (20/25) or better after cataract removal and IOL implantation as determined by surgeon.
- 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.
- Clear intraocular media other than cataract.
- Planned Bilateral implantation of the Clareon Vivity and Vivity toric IOLs.
- IOL powers between 6D and 30D, T2-T6.
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 ocular or refractive surgery
- Ocular surface disease/Dry Eye Disease
- Intraoperative complications during procedure
- Glaucoma, including well-controlled
- Any disorders that reduce binocular vision (ie Strabismus)
- Any ocular comorbidity that, in the opinion of the investigator reduce post-op visual acuity (e.g. AMD etc)
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
The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.
Read the detailed description
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) 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
- Clareon Vivity extended depth of focus (EDOF) intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon Vivity extended depth of focus (EDOF) intraocular lensDevice
Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Clareon Vivity extended depth of focus (EDOF) intraocular lens | Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens Receives: Device: Clareon Vivity extended depth of focus (EDOF) intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular distance-corrected visual acuity at distance (6m)
Measured: 3 months postoperative
Binocular distance-corrected visual acuity at intermediate (66cm)
Measured: 3 months postoperative
Secondary outcomes (2)
Percentage of eyes with absolute prediction error less than or equal to 0.50D
Measured: 3 months postoperative
Percentage of eyes with refractive astigmatism less than or equal to 0.50 D
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 posted5 Aug 2022
- Study start25 Aug 2022
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Why it stopped: Investigational product not available
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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Nagy
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor-investigator, Thomas Nagy, Vision North Eye Centre
- Investigators
- Thomas Nagy, MD, Principal investigator, Vision North Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488769
- Sponsor's protocol ID
- TN-22-001
- Status last verified
- Jan 2023
- First submitted
- 3 Aug 2022
- Last updated
- 19 Jan 2023
- 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 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material
- ClinicalTrials.gov ID
- NCT05488769
- Acronym / sponsor ID
- TN-22-001
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigational product not available
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Thomas NagyUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 5 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.
The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.
Detailed description
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) 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 |
|---|---|---|
| Clareon Vivity extended depth of focus (EDOF) intraocular lens | – | Device: Clareon Vivity extended depth of focus (EDOF) intraocular lensImplantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible test subjects will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for intermediate and distance vision, and who are considered appropriate candidates for EDOF lens implantation.
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 extended depth of focus (EDOF) intraocular lensImplantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens | Device | Clareon Vivity extended depth of focus (EDOF) intraocular lens |
Primary outcome
Binocular distance-corrected visual acuity at distance (6m)
Time frame: 3 months postoperative
Binocular distance-corrected visual acuity at intermediate (66cm)
Time frame: 3 months postoperative
2 secondary outcomes
Percentage of eyes with absolute prediction error less than or equal to 0.50D
Time frame: 3 months postoperative
Percentage of eyes with refractive astigmatism less than or equal to 0.50 D
Time frame: 3 months postoperative
Results and safety
The study was stopped early (reason given: Investigational product not available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- 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 Nagy, MD principal investigator
Vision North Eye Centre
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 Thomas Nagy at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jan 2023. 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: Investigational product not available). 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?
Binocular distance-corrected visual acuity at distance (6m) (time frame: 3 months postoperative). 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 19 Jan 2023.