An observational study in Pseudophakia, sponsored by Berkeley Eye Center. Completed at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Berkeley Eye Center · Observational
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.
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
54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.
This study's enrollment of 20 is below the median of 71 across 26 observational studies indexed under Pseudophakia.
Browse Pseudophakia studies →Berkeley Eye Center is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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*).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with bilateral implantation of Vivity IOLs.
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
Monocular and binocular measurement of distance, intermediate, and near visual acuity
Measurement of a defocus curve
Self-reported post-operative patient satisfaction with vision after surgery
Self-reported post-operative patient vision quality after surgery
Questionnaire of self-reported visual disturbances of patients
Topography and tomography measurements with Atlas, iTrace, and/or Pentacam
Binocular Best Corrected Distance Visual Acuity
Binocular Best Corrected Distance Visual Acuity in logMAR
Time frame: 3 weeks post operatively
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)
Time frame: 3 weeks post operatively
Binocular Distance, Intermediate, and Near Visual Acuity
Binocular distance (UDVA), intermediate (UIVA, DCIVA), and near visual acuity (UNVA, DCNVA)
Time frame: 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.
Time frame: 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.
Time frame: 3 weeks post operatively
Post-op Refraction
Manifest refraction spherical equivalent (MRSE)
Time frame: 3 weeks post operatively
Binocular Defocus Curve
Binocular defocus curve (distance corrected)
Time frame: 3 weeks post operatively
Spectacle Independence (IOLSAT)
Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. Spectacle independence was defined as answering "Never" or "Rarely" on the IOLSAT, the data presented is the percentage of subjects answering "Never" or "Rarely".
Time frame: 3 weeks post operatively
| Milestone | Vivity IOL Group |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Binocular Best Corrected Distance Visual Acuity in logMAR
| logMAR | Vivity IOL Group |
|---|---|
| Binocular Best Corrected Distance Visual Acuity | -0.05 ± 0.09 |
Monocular UDVA (uncorrected distance visual acuity), UIVA (uncorrected intermediate visual acuity), UNVA (uncorrected near visual acuity), and CDVA (corrected distance visual acuity)
| logMAR | Vivity IOL Group |
|---|---|
| UDVA | 0.06 ± 0.11 |
| UIVA | 0.18 ± 0.12 |
| UNVA | 0.31 ± 0.19 |
| CDVA | 0.00 ± 0.08 |
Binocular distance (UDVA), intermediate (UIVA, DCIVA), and near visual acuity (UNVA, DCNVA)
| logMAR | Vivity IOL Group |
|---|---|
| UDVA | 0.02 ± 0.16 |
| UIVA | 0.14 ± 0.13 |
| DCIVA | 0.11 ± 0.11 |
| UNVA | 0.24 ± 0.14 |
| DCNVA | 0.25 ± 0.15 |
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.
| Participants | Vivity IOL Group |
|---|---|
| Starburst | 11 |
| Halos | 13 |
| Glare | 9 |
| Haze | 15 |
| Blurred Vision | 15 |
| Double Vision | 19 |
| Dark Area | 20 |
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.
| Participants | Vivity IOL Group |
|---|---|
| Intraocular Lens Satisfaction (IOLSAT) Questionnaire | 16 |
Manifest refraction spherical equivalent (MRSE)
| D | Vivity IOL Group |
|---|---|
| Post-op Refraction | -0.11 ± 0.31 |
Binocular defocus curve (distance corrected)
| logMAR | Vivity IOL Group |
|---|---|
| -3.00 D | 0.39 ± 0.17 |
| -2.50 D | 0.26 ± 0.17 |
| -2.00 D | 0.17 ± 0.13 |
| -1.50 D | 0.05 ± 0.12 |
| -1.00 D | 0.03 ± 0.11 |
| -0.50 D | 0.00 ± 0.11 |
| -0.25 D | -0.05 ± 0.09 |
| 0.00 D | -0.06 ± 0.09 |
| 0.25 D | -0.02 ± 0.10 |
| 0.50 D | 0.00 ± 0.10 |
| 1.00 D | 0.11 ± 0.10 |
Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. Spectacle independence was defined as answering "Never" or "Rarely" on the IOLSAT, the data presented is the percentage of subjects answering "Never" or "Rarely".
| percentage of participants | Vivity IOL Group |
|---|---|
| Overall | 90 |
| Distance | 90 |
| Intermediate | 75 |
| Near | 30 |
Collected over 3 weeks postoperatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vivity IOL Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Vivity IOL Group |
|---|---|
| Mean | 68.0 ± 6.0 |
| Sex: Female, Male(Participants) | Vivity IOL Group |
|---|---|
| Female | 9 |
| Male | 11 |
| Race and Ethnicity Not Collected(Participants) | Vivity IOL Group |
|---|
Plan to share: No
Ran from Jul 2023 to primary completion in Dec 2024, 16 months.
Results were first posted in May 2025, 5 months after primary completion.
Of 16 observational studies under Pseudophakia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 16 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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