CataractNCT04482439
Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye
A study testing Vivity Extended Depth of Focus intraocular lens (IOL) in people with Cataract, run by Newsom Eye & Laser Center at 1 site in United States.
Trial summary
The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Vivity Extended Depth of Focus intraocular lens (IOL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2020to 10 Jun 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an EDF IOL
- Meet the requirements for on-label implantation of the EDF IOL
- Gender: Males and Females.
- Age: 40 or older.
- 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.
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- Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
- Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or toric IOL.
- Have 20/32 (0.2 logMAR) or better potential acuity in both eyes
Who cannot join
- • Irregular astigmatism (e.g. keratoconus)
- Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)
- Monocular status (e.g. amblyopia)
- Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- Diabetic retinopathy
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- Macular pathology (e.g. ARMD, ERM)
- History of retinal detachment
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the AcrySof® Vivity Intraocular Lens With a Target of Slight Myopia in the Non-dominant Eye
The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.
Read the detailed description
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, 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), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
- Conditions
- Cataract
- Being tested
- Vivity Extended Depth of Focus intraocular lens (IOL)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivity Extended Depth of Focus intraocular lens (IOL)Device
Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.
| Study group | Role | What they receive |
|---|---|---|
| Vivity mini-monovision | Experimental | Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye. Receives: Device: Vivity Extended Depth of Focus intraocular lens (IOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Near Visual Acuity
binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.
Measured: 3 months postop
Secondary outcomes (11)
Prediction Accuracy
Percentage of eyes with postoperative refractive accuracy within 0.5D of target
Measured: 3 months postop
Spectacle Independence
Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time")
Measured: 3 months postop
Patient Spectacle Independence
Patients reporting rarely or never needing glasses overall
Measured: 3 months postop
Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"
This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts.
Measured: 3 months postop
Manifest Refraction
Manifest refraction (residual spherical equivalent refraction)
Measured: 3 months postop
Residual Cylinder
Residual refractive cylinder after surgery
Measured: 3 months
Uncorrected Distance Visual Acuity
Bilateral uncorrected distance visual acuity
Measured: 3 months postop
Uncorrected Intermediate Visual Acuity
Bilateral uncorrected visual acuity at 66 cm
Measured: 3 months postop
Uncorrected Near Visual Acuity
Bilateral uncorrected near visual acuity at 40 cm
Measured: 3 months postop
Corrected Distance Visual Acuity
Bliateral corrected distance visual acuity
Measured: 3 months postop
Distance Corrected Intermediate Visual Acuity
Bliateral distance corrected visual acuity at 66 cm
Measured: 3 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start17 Jul 2020
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newsom Eye & Laser Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Newsom, MD, Principal investigator, Newsom Eye & Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482439
- Sponsor's protocol ID
- TN-20-001
- Status last verified
- Jan 2022
- First submitted
- 17 Jul 2020
- Last updated
- 3 Mar 2022
- 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 3 Mar 2022. 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 AcrySof® Vivity Intraocular Lens With a Target of Slight Myopia in the Non-dominant Eye
- ClinicalTrials.gov ID
- NCT04482439
- Acronym / sponsor ID
- TN-20-001
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Newsom Eye & Laser CenterUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Posted 3 Mar 2022
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 assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.
Detailed description
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, 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), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery.
| Arm | Type | Receives |
|---|---|---|
| Vivity mini-monovision | Experimental | Device: Vivity Extended Depth of Focus intraocular lens (IOL)Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an EDF IOL
Key exclusion criteria (10 listed)
- • Irregular astigmatism (e.g. keratoconus)
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 |
|---|---|---|
| Vivity Extended Depth of Focus intraocular lens (IOL)Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye. | Device | Vivity mini-monovision |
Primary outcome
Binocular Near Visual Acuity
Time frame: 3 months postop
binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.
11 secondary outcomes
Prediction Accuracy
Time frame: 3 months postop
Spectacle Independence
Time frame: 3 months postop
Patient Spectacle Independence
Time frame: 3 months postop
Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"
Time frame: 3 months postop
Manifest Refraction
Time frame: 3 months postop
Residual Cylinder
Time frame: 3 months
Uncorrected Distance Visual Acuity
Time frame: 3 months postop
Uncorrected Intermediate Visual Acuity
Time frame: 3 months postop
Uncorrected Near Visual Acuity
Time frame: 3 months postop
Corrected Distance Visual Acuity
Time frame: 3 months postop
Distance Corrected Intermediate Visual Acuity
Time frame: 3 months postop
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- 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 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?
A study testing Vivity Extended Depth of Focus intraocular lens (IOL) in people with 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 9 inclusion and 10 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 3 Mar 2022. 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 3 Mar 2022). 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 Near Visual Acuity (time frame: 3 months postop). 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 3 Mar 2022.