CataractNCT05961046
Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients
An observational study of Cataract, run by Laser & Corneal Surgery Associates at 2 sites in United States.
Trial summary
The objective is to evaluate visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Vivity IOL
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Aug 2023to 13 Jun 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible test subjects will be patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL at least 3 months ago.
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 (at least 40 years) patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL at least 3 months before enrollment.
- Monocular BCDVA 20/25 or better.
- Patients may be >2 weeks post-YAG capsulotomy for visually significant PCO.
- Post-operative sphere ≤0.50D, astigmatism ≤0.50D, and MRSE < 0.75D.
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 corneal refractive surgery complications, significant ocular pathology, including moderate and severe dry eye, retina, optic nerve (including glaucoma) and corneal pathologies (e.g. corneal dystrophy, edema, significant scarring), limiting or affecting visual potential, in the opinion of the surgeon.
- Patients undergoing cataract removal with MIGS procedure.
- Patients with h/o ocular surgery, other than corneal refractive surgery, that may limit or affect visual potential in the opinion of the surgeon.
- 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
2 sites in 1 country.
United States2 sites
LCSA Manhattan
New York, New York, 10016
LCSA White Plains
White Plains, New York, 10605
About this study
The objective is to evaluate visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL.
Read the detailed description
This study Prospective, non-interventional, single-center, single-surgeon, single-arm observational study of visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL. Subjects will be assessed at least 3 months postoperatively. Clinical evaluations will include administration of a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities, defocus curve, and manifest refraction.
- Conditions
- Cataract
- Being tested
- Vivity 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 IOLDevice
Vivity IOL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL Receives: Device: Vivity IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular corrected distance visual acuity
Measured: 3 months after surgery
Secondary outcomes (8)
Monocular uncorrected visual acuity
At distance, intermediate, and near
Measured: 3 months after surgery
Monocular corrected visual acuity
At distance, intermediate, and near
Measured: 3 months after surgery
Binocular corrected visual acuity
At intermediate and near
Measured: 3 months after surgery
Binocular uncorrected visual acuity
At distance, intermediate, and near
Measured: 3 months after surgery
Binocular Defocus curve
Measured: 3 months after surgery
Satisfaction Questionnaire
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.
Measured: 3 months after surgery
Visual Disturbance Questionnaire
Lower scores indicate less severe visual disturbances.
Measured: 3 months after surgery
Refractive Outcomes
Manifest refraction spherical equivalent (MRSE), residual sphere, astigmatism
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start17 Aug 2023
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Why it stopped: Low recruitment
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
- Laser & Corneal Surgery Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Jimmy Y Hu, MD, Principal investigator, Laser and Corneal Surgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961046
- Sponsor's protocol ID
- JH-23-01
- Status last verified
- Jun 2024
- First submitted
- 10 Jul 2023
- Last updated
- 17 Jun 2024
- 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 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients
- ClinicalTrials.gov ID
- NCT05961046
- Acronym / sponsor ID
- JH-23-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Laser & Corneal Surgery AssociatesUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 27 Jul 2023 (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 evaluate visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL.
Detailed description
This study Prospective, non-interventional, single-center, single-surgeon, single-arm observational study of visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL. Subjects will be assessed at least 3 months postoperatively. Clinical evaluations will include administration of a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities, defocus curve, and manifest refraction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Vivity IOLPatients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible test subjects will be patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL at least 3 months ago.
Key inclusion criteria (6 listed)
- Note: Ocular criteria must be met in both eyes.
- Adult (at least 40 years) patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL at least 3 months before enrollment.
- Monocular BCDVA 20/25 or better.
- Patients may be >2 weeks post-YAG capsulotomy for visually significant PCO.
- Post-operative sphere ≤0.50D, astigmatism ≤0.50D, and MRSE < 0.75D.
Key exclusion criteria (6 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 corneal refractive surgery complications, significant ocular pathology, including moderate and severe dry eye, retina, optic nerve (including glaucoma) and corneal pathologies (e.g. corneal dystrophy, edema, significant scarring), limiting or affecting visual potential, in the opinion of the surgeon.
- Patients undergoing cataract removal with MIGS procedure.
- Patients with h/o ocular surgery, other than corneal refractive surgery, that may limit or affect visual potential in the opinion of the surgeon.
- 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.
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 IOLVivity IOL | Device | 1 |
Primary outcome
Binocular corrected distance visual acuity
Time frame: 3 months after surgery
8 secondary outcomes
Monocular uncorrected visual acuity
Time frame: 3 months after surgery
Monocular corrected visual acuity
Time frame: 3 months after surgery
Binocular corrected visual acuity
Time frame: 3 months after surgery
Binocular uncorrected visual acuity
Time frame: 3 months after surgery
Binocular Defocus curve
Time frame: 3 months after surgery
Satisfaction Questionnaire
Time frame: 3 months after surgery
Visual Disturbance Questionnaire
Time frame: 3 months after surgery
Refractive Outcomes
Time frame: 3 months after surgery
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- 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.
Jimmy Y Hu, MD principal investigator
Laser and Corneal Surgery Associates
2 sites 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 Laser & Corneal Surgery Associates at 2 sites 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 6 inclusion and 6 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 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Low recruitment). 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 corrected distance visual acuity (time frame: 3 months after surgery). 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 17 Jun 2024.