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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivity IOL Group | Patients with bilateral implantation of Vivity IOLs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Acuity | Diagnostic Test | Monocular and binocular measurement of distance, intermediate, and near visual acuity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Best Corrected Distance Visual Acuity | Binocular Best Corrected Distance Visual Acuity in logMAR | 3 weeks post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 weeks post operatively |
| Binocular Distance, Intermediate, and Near Visual Acuity |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Defocus Curve | Binocular defocus curve (distance corrected) | 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". |
Inclusion Criteria:
Exclusion Criteria:
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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*).
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| Name | Affiliation | Role |
|---|---|---|
| Morgan Micheletti, MD | Berkeley Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berkeley Eye Center | Houston | Texas | 77027 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vivity IOL Group | Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 25, 2023 | May 7, 2025 |
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| Defocus Curve | Diagnostic Test | Measurement of a defocus curve |
|
| Intraocular Lens Satisfaction (IOLSAT) Questionnaire | Other | Self-reported post-operative patient satisfaction with vision after surgery |
|
| Quality of Vision After Surgery (QUVID) Questionnaire | Other | Self-reported post-operative patient vision quality after surgery |
|
| Visual Disturbance Questionnaire | Other | Questionnaire of self-reported visual disturbances of patients |
|
| Topography and Tomography | Diagnostic Test | Topography and tomography measurements with Atlas, iTrace, and/or Pentacam |
|
Binocular distance (UDVA), intermediate (UIVA, DCIVA), and near visual acuity (UNVA, DCNVA) |
| 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. | 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. | 3 weeks post operatively |
| Post-op Refraction | Manifest refraction spherical equivalent (MRSE) | 3 weeks post operatively |
| 3 weeks post operatively |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vivity IOL Group | Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Binocular Best Corrected Distance Visual Acuity | Binocular Best Corrected Distance Visual Acuity in logMAR | Posted | Mean | Standard Deviation | logMAR | 3 weeks post operatively |
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| Secondary | 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) | Posted | Mean | Standard Deviation | logMAR | 3 weeks post operatively | eyes | eyes |
|
| |||||||||||||||||||||||||
| Secondary | Binocular Distance, Intermediate, and Near Visual Acuity | Binocular distance (UDVA), intermediate (UIVA, DCIVA), and near visual acuity (UNVA, DCNVA) | Posted | Mean | Standard Deviation | logMAR | 3 weeks post operatively |
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| Secondary | 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. | Posted | Count of Participants | Participants | 3 weeks post operatively |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 3 weeks post operatively |
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| Secondary | Post-op Refraction | Manifest refraction spherical equivalent (MRSE) | Posted | Mean | Standard Deviation | D | 3 weeks post operatively | eyes | eyes |
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| Other Pre-specified | Binocular Defocus Curve | Binocular defocus curve (distance corrected) | Posted | Mean | Standard Deviation | logMAR | 3 weeks post operatively |
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| Other Pre-specified | 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". | Posted | Number | percentage of participants | 3 weeks post operatively |
|
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3 weeks postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vivity IOL Group | Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam | 0 | 20 | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tetiana Huff | Berkeley Eye Center | 713-620-7640 | tetiana.huff@berkeleyeye.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014792 | Visual Acuity |
| D011795 | Surveys and Questionnaires |
| D014054 | Tomography |
| ID | Term |
|---|---|
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009799 | Ocular Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D003952 | Diagnostic Imaging |
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