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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
| Florida Eye Specialists | UNKNOWN |
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The goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation.
The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision?
Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following:
Researchers will assess participant examination results to determine whether an association exists between IOL movement and patient quality of vision.
This is a non-interventional, single-center, multi-surgeon, observational study to evaluate the effect of intraocular lens (IOL) centration and tilt on visual performance in patients who have undergone Clareon® Vivity® IOL implantation. The study population will include individuals implanted with Clareon® Vivity® and Vivity® Toric IOLs. IOL implantations reviewed will range from the earliest performed (May 2022) onward, until 100 implanted patients (200 eyes) are enrolled. Potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| CDVA100 | The mean between Monocular best-corrected distance visual acuity (CDVA100) (logMAR) (High Contrast - 100%). | 1 Day |
| IOL Decentration | The mean value and standard deviation of IOL decentration. | 1 day |
| IOL Tilt | The mean value and standard deviation of IOL tilt. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| UCDVA100 | The mean between Uncorrected Distance Visual Acuity (UCDVA100) (logMAR) (High Contrast - 100%) | 1 day |
| UCIVA100 | The mean between Uncorrected Intermediate Visual Acuity (UCIVA100) (logMAR) (High Contrast - 100%). |
| Measure | Description | Time Frame |
|---|---|---|
| CDVA25 | The mean between Corrected Distant Visual Acuity (logMAR) (Low Contrast - 25%). | 1 day |
| Mesopic Pupil Size | The mean between Mesopic Pupil Size (mm). |
Inclusion Criteria:
Exclusion Criteria:
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The study population will include approximately 100 adult participants (200 eyes) who have previously been implanted with Clareon® Vivity® and Vivity® Toric intraocular lenses (IOLs).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Coast Institute for Research | Jacksonville | Florida | 32216 | United States |
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Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs).
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| ID | Title | Description |
|---|---|---|
| FG000 | Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
| ID | Title | Description |
|---|---|---|
| BG000 | Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age | Age of Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) |
| 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 | CDVA100 | The mean between Monocular best-corrected distance visual acuity (CDVA100) (logMAR) (High Contrast - 100%). | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | logMAR | 1 Day | Eyes | Eyes |
|
|
1 day
An adverse event (AE) is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a test article or in a clinical study.
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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 | Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Goldfaden, PharmD, CCRP | East Coast Institute for Research at Florida Eye Specialists | 904-854-1354 | rg@roviaclinical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2023 | Oct 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 1 day |
| DCIVA100 | The mean between Distance Corrected Intermediate Visual Acuity (100%) (DCIVA100) (logMAR) (High Contrast - 100%). | 1 day |
| MRSE | The mean between Manifest Refraction Spherical Equivalent (MRSE) (D). | 1 day |
| 1 day |
| HOA S | The mean between Higher-Order Aberration, Spherical (HOA S) (µm) | 1 day |
| HOA CH | The mean between Higher-Order Aberration- Coma, Horizontal (HOA CH). | 1 day |
| HOA CV | The mean between Higher-Order Aberration- Coma, Vertical (HOA CV) (µm). | 1 day |
| Eyes |
|
| Mean |
| Standard Deviation |
| years |
| Participants |
|
| Sex: Female, Male | Sex | Sex of Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Race for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity | Ethnicity for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Count of Participants | Participants | Participants |
|
| IOL Type | IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Count of Participants | Participants | Participants |
|
| Pre-Op CDVA High-Contrast | Pre-operation Data High-Contrast CDVA in IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Mean | Standard Deviation | logMAR | Participants |
|
| Pre-Op MRSE | Pre-operation Data MRSE in IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs) | Mean | Standard Deviation | D | Participants |
|
|
| Eyes |
|
|
|
| Secondary | UCDVA100 | The mean between Uncorrected Distance Visual Acuity (UCDVA100) (logMAR) (High Contrast - 100%) | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | logMAR | 1 day | Eyes | Eyes |
|
|
|
|
| Secondary | UCIVA100 | The mean between Uncorrected Intermediate Visual Acuity (UCIVA100) (logMAR) (High Contrast - 100%). | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | logMAR | 1 day | Eyes | Eyes |
|
|
|
|
| Secondary | DCIVA100 | The mean between Distance Corrected Intermediate Visual Acuity (100%) (DCIVA100) (logMAR) (High Contrast - 100%). | All participants were analyzed. | Posted | Mean | Standard Deviation | logMAR | 1 day | Eyes | Eyes |
|
|
|
|
| Secondary | MRSE | The mean between Manifest Refraction Spherical Equivalent (MRSE) (D). | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | D | 1 day | Eyes | Eyes |
|
|
|
|
| Other Pre-specified | CDVA25 | The mean between Corrected Distant Visual Acuity (logMAR) (Low Contrast - 25%). | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | logMAR | 1 day | Eyes | Eyes |
|
|
|
|
| Other Pre-specified | Mesopic Pupil Size | The mean between Mesopic Pupil Size (mm). | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | mm | 1 day | Eyes | Eyes |
|
|
|
|
| Other Pre-specified | HOA S | The mean between Higher-Order Aberration, Spherical (HOA S) (µm) | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | µm | 1 day | Eyes | Eyes |
|
|
|
|
| Other Pre-specified | HOA CH | The mean between Higher-Order Aberration- Coma, Horizontal (HOA CH). | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | µm | 1 day | Eyes | Eyes |
|
|
|
|
| Other Pre-specified | HOA CV | The mean between Higher-Order Aberration- Coma, Vertical (HOA CV) (µm). | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | µm | 1 day | Eyes | Eyes |
|
|
|
|
| Primary | IOL Decentration | The mean value and standard deviation of IOL decentration. | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | mm | 1 day | Eyes | Eyes |
|
|
|
| Primary | IOL Tilt | The mean value and standard deviation of IOL tilt. | All participants enrolled were analyzed. | Posted | Mean | Standard Deviation | degree | 1 day | Eyes | Eyes |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
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| t-test, 2 sided |
| 0.99 |
| Pearson correlation coefficient r value |
| 0.001 |
| 2-Sided |
| 95 |
| -0.14 |
| 0.14 |
| Other |
Relationship between UCDVA (4m) with IOL Tilt |
| t-test, 2 sided |
| 0.06 |
| Pearson correlation coefficient r value |
| -0.13 |
| 2-Sided |
| 95 |
| -0.27 |
| 0.0004 |
| Other |
Relationship between UCIVA (66m) with IOL Tilt |
| t-test, 2 sided |
| 0.07 |
| Pearson correlation coefficient r value |
| -0.13 |
| 2-Sided |
| 95 |
| -0.26 |
| 0.009 |
| Other |
Relationship between DCIVA (66cm) with IOL Tilt |
| t-test, 2 sided |
| 0.27 |
| Pearson correlation coefficient r value |
| -0.08 |
| 2-Sided |
| 95 |
| -0.22 |
| 0.06 |
| Other |
Relationship between MRSE (D) with IOL Tilt |
| t-test, 2 sided |
| 0.53 |
| Pearson correlation coefficient r value |
| -0.04 |
| 2-Sided |
| 95 |
| -0.18 |
| 0.09 |
| Other |
Relationship between CDVA25 (logMAR) with IOL Tilt |
Relationship between Mesopic Pupil Size (mm) with IOL Tilt
| t-test, 2 sided |
| 0.56 |
| Pearson correlation coefficient r value |
| 0.04 |
| 2-Sided |
| 95 |
| -0.010 |
| 0.18 |
| Other |
Relationship between Mesopic Pupil Size (mm) with IOL Tilt |
| t-test, 2 sided |
| 0.66 |
| Pearson correlation coefficient r value |
| -0.03 |
| 2-Sided |
| 95 |
| -0.17 |
| 0.11 |
| Other |
Relationship between HOA S (µm) with IOL Tilt |
| t-test, 2 sided |
| 0.38 |
| Pearson correlation coefficient r value |
| -0.06 |
| 2-Sided |
| 95 |
| -0.12 |
| 0.16 |
| Other |
Relationship between HOA CH (µm) with IOL Tilt |
| t-test, 2 sided |
| 0.07 |
| Pearson correlation coefficient r value |
| -0.13 |
| 2-Sided |
| 95 |
| -0.26 |
| 0.01 |
| Other |
Relationship between HOA CV (µm) with IOL Tilt |