PseudophakiaNCT06064916
Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
An observational study of Pseudophakia, run by Berkeley Eye Center at 1 site in United States.
Trial summary
This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT***/CCWET*). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudophakia
- What is being tested?
- Visual Acuity, Defocus Curve and Intraocular Lens Satisfaction (IOLSAT) Questionnaire
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2023to 11 Dec 2024
- How long will I take part?
- 1 Day
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with healthy eyes, prior myopic LASIK or PRK with SA greater than 0.3, and uncomplicated bilateral implantation of the Vivity IOL (DAT***/CCWET*).
Who may be able to join
- Adults, 40 years of age having already undergone cataract removal by phacoemulsification with a clear corneal incision in both eyes with implantation of the Vivity IOL (DAT***/CCWET*)
- Prior uncomplicated, distance-targeted, bilateral myopic LASIK or PRK (photorefractive keratectomy) surgery and corneal spherical aberration greater than ≥0.30 μ and ≤ 1.20 μ in at least one eye (6.00 mm) as measured at their cataract pre-op visit
- Able to comprehend and willing to sign informed consent and complete all required testing procedures
- Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
- Clear intraocular media
- Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
- Residual refractive astigmatism ≤0.50 diopters
- Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent
Who cannot join
- Any corneal abnormality, other than regular corneal astigmatism or myopic LASIK/PRK surgery, (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
- Any complication during cataract surgery (capsular tear, vitrectomy, etc)
- History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
- Amblyopia or strabismus in either eye
- History of or current anterior or posterior segment inflammation of any etiology
- Any form of neovascularization on or within the eye
Show all 11Show fewer
- Glaucoma (uncontrolled or controlled with medication)
- Optic nerve atrophy
- Subjects with diagnosed degenerative eye disorders
- Postoperative CDVA worse than 0.10 logMAR in either eye.
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)
Trial locations and contacts
1 site in 1 country.
About this study
This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT***/CCWET*).
Patients will be assessed for monocular and binocular distance, intermediate, and near vision.
Read the detailed description
This is a non-interventional, prospective, single center, bilateral, observational study of the outcomes for 40 post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT***/CCWET*) performed by 4 surgeons using similar surgical techniques. 40 subjects will be enrolled.
Patients will be assessed for monocular and binocular distance, intermediate, and near vision.
The hypothesis is that post-refractive patients that have high spherical aberration (SAs) will have excellent outcomes and satisfaction with a Vivity IOL
- Conditions
- Pseudophakia
- Being tested
- Visual Acuity, Defocus Curve, Intraocular Lens Satisfaction (IOLSAT) Questionnaire, Quality of Vision After Surgery (QUVID) Questionnaire, Visual Disturbance Questionnaire
- Keywords
- Vivity, Pseudophakia
- Medical subject headings
- Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual AcuityDiagnostic test
Monocular and binocular measurement of distance, intermediate, and near visual acuity
Defocus CurveDiagnostic test
Measurement of a defocus curve
Intraocular Lens Satisfaction (IOLSAT) QuestionnaireOther
Self-reported post-operative patient satisfaction with vision after surgery
Quality of Vision After Surgery (QUVID) QuestionnaireOther
Self-reported post-operative patient vision quality after surgery
Visual Disturbance QuestionnaireOther
Questionnaire of self-reported visual disturbances of patients
Topography and TomographyDiagnostic test
Topography and tomography measurements with Atlas, iTrace, and/or Pentacam
| Study group | Role | What they receive |
|---|---|---|
| Vivity IOL Group | Patients with bilateral implantation of Vivity IOLs. Receives: Diagnostic Test: Visual Acuity; Diagnostic Test: Defocus Curve; Other: Intraocular Lens Satisfaction (IOLSAT) Questionnaire; Other: Quality of Vision After Surgery (QUVID) Questionnaire; Other: Visual Disturbance Questionnaire; Diagnostic Test: Topography and Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Best Corrected Distance Visual Acuity
Binocular Best Corrected Distance Visual Acuity in logMAR
Measured: 3 weeks post operatively
Secondary outcomes (5)
Monocular Visual Acuity
Monocular UDVA (uncorrected distance visual acuity), UIVA (uncorrected intermediate visual acuity), UNVA (uncorrected near visual acuity), and CDVA (corrected distance visual acuity)
Measured: 3 weeks post operatively
Binocular Distance, Intermediate, and Near Visual Acuity
Binocular distance (UDVA), intermediate (UIVA, DCIVA), and near visual acuity (UNVA, DCNVA)
Measured: 3 weeks post operatively
Quality of Vision After Surgery (QUVID) Questionnaire
Patient reported disphotopsias by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of subjects that answered "Never" or "Rarely" for frequency are provided.
Measured: 3 weeks post operatively
Intraocular Lens Satisfaction (IOLSAT) Questionnaire
Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of patients "Satisfied" or "Very Satisfied" will be added for a total satisfaction percentage.
Measured: 3 weeks post operatively
Post-op Refraction
Manifest refraction spherical equivalent (MRSE)
Measured: 3 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start25 Jul 2023
- Primary completion11 Dec 2024
- Study completion11 Dec 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 PseudophakiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Berkeley Eye Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Micheletti, MD, Principal investigator, Berkeley Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064916
- Sponsor's protocol ID
- 69865263
- Status last verified
- May 2025
- First submitted
- 12 Sep 2023
- Last updated
- 23 May 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
- ClinicalTrials.gov ID
- NCT06064916
- Acronym / sponsor ID
- 69865263
- Conditions
- Pseudophakia
- Keywords
- Vivity, Pseudophakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Berkeley Eye CenterUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT***/CCWET*).
Patients will be assessed for monocular and binocular distance, intermediate, and near vision.
Detailed description
This is a non-interventional, prospective, single center, bilateral, observational study of the outcomes for 40 post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT***/CCWET*) performed by 4 surgeons using similar surgical techniques. 40 subjects will be enrolled.
Patients will be assessed for monocular and binocular distance, intermediate, and near vision.
The hypothesis is that post-refractive patients that have high spherical aberration (SAs) will have excellent outcomes and satisfaction with a Vivity IOL
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vivity IOL Group | – | Diagnostic Test: Visual Acuity, Diagnostic Test: Defocus Curve, Other: Intraocular Lens Satisfaction (IOLSAT) Questionnaire, Other: Quality of Vision After Surgery (QUVID) Questionnaire, Other: Visual Disturbance Questionnaire, Diagnostic Test: Topography and TomographyPatients with bilateral implantation of Vivity IOLs. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with healthy eyes, prior myopic LASIK or PRK with SA greater than 0.3, and uncomplicated bilateral implantation of the Vivity IOL (DAT***/CCWET*).
Key inclusion criteria (8 listed)
- Adults, 40 years of age having already undergone cataract removal by phacoemulsification with a clear corneal incision in both eyes with implantation of the Vivity IOL (DAT***/CCWET*)
- Prior uncomplicated, distance-targeted, bilateral myopic LASIK or PRK (photorefractive keratectomy) surgery and corneal spherical aberration greater than ≥0.30 μ and ≤ 1.20 μ in at least one eye (6.00 mm) as measured at their cataract pre-op visit
- Able to comprehend and willing to sign informed consent and complete all required testing procedures
- Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
- Clear intraocular media
Key exclusion criteria (11 listed)
- Any corneal abnormality, other than regular corneal astigmatism or myopic LASIK/PRK surgery, (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
- Any complication during cataract surgery (capsular tear, vitrectomy, etc)
- History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
- Amblyopia or strabismus in either eye
- History of or current anterior or posterior segment inflammation of any etiology
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 |
|---|---|---|
| Visual AcuityMonocular and binocular measurement of distance, intermediate, and near visual acuity | Diagnostic test | Vivity IOL Group |
| Defocus CurveMeasurement of a defocus curve | Diagnostic test | Vivity IOL Group |
| Intraocular Lens Satisfaction (IOLSAT) QuestionnaireSelf-reported post-operative patient satisfaction with vision after surgery | Other | Vivity IOL Group |
| Quality of Vision After Surgery (QUVID) QuestionnaireSelf-reported post-operative patient vision quality after surgery | Other | Vivity IOL Group |
| Visual Disturbance QuestionnaireQuestionnaire of self-reported visual disturbances of patients | Other | Vivity IOL Group |
| Topography and TomographyTopography and tomography measurements with Atlas, iTrace, and/or Pentacam | Diagnostic test | Vivity IOL Group |
Primary outcome
Binocular Best Corrected Distance Visual Acuity
Time frame: 3 weeks post operatively
Binocular Best Corrected Distance Visual Acuity in logMAR
5 secondary outcomes
Monocular Visual Acuity
Time frame: 3 weeks post operatively
Binocular Distance, Intermediate, and Near Visual Acuity
Time frame: 3 weeks post operatively
Quality of Vision After Surgery (QUVID) Questionnaire
Time frame: 3 weeks post operatively
Intraocular Lens Satisfaction (IOLSAT) Questionnaire
Time frame: 3 weeks post operatively
Post-op Refraction
Time frame: 3 weeks post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pseudophakia
RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Dysphotopsia, Posterior Capsule Opacification
Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
Enrolling by invitation
Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
Pseudophakia, Myopia
Enrolling by invitation
Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile
Pseudophakia, Myopia
Active, not recruiting
Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
Pseudophakia, Hypermetropia
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.
Morgan Micheletti, MD principal investigator
Berkeley Eye 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 Pseudophakia, run by Berkeley Eye 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 8 inclusion and 11 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 23 May 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 23 May 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 Best Corrected Distance Visual Acuity (time frame: 3 weeks post operatively). 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 23 May 2025.