Cataract, Lenses, Intraocular
Conditions
Keywords
Extended Depth of Focus Lens, Toric Lens, Decentration, Tilt, Clareon Vivity, Clareon Vivity Toric
Brief summary
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: * consent to participate in the study * allow researchers to access their personal medical records * undergo a series of tests to assess the position of their IOLs and quality of vision Researchers will assess participant examination results to determine whether an association exists between IOL movement and patient quality of vision.
Detailed description
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
East Coast Institute for Research
Alcon Research
Florida Eye Specialists
Study design
Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * History of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric intraocular lens (IOL) implantation with manifest refraction spherical equivalent (MRSE) within ±1.00 D * Willing to undergo an eye exam with pupil dilation
Exclusion criteria
* Moderate to severe posterior capsule opacification (2+ or more) * Yttrium aluminum garnet (YAG) laser capsulotomy within 1 month prior to enrollment * Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) within the one year prior to IOL implantation or any time after IOL implantation * Any previous ocular surgery (excluding YAG, LASIK, PRK) * Clinically significant ocular pathology; severe diabetic retinopathy, age-related macular degeneration (AMD), glaucoma, severe dry eye, irregular astigmatism, zonular weakness, pseudoexfoliation, ocular trauma * Any additional procedure(s) at the same time as the Vivity implantation including but not limited to microinvasive glaucoma surgery (MIGS) * Women who are pregnant at the time of screening (based on self-reported history) * Medical or other problems which in the opinion of the investigator will render study participation unsafe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CDVA100 | 1 Day | The mean between Monocular best-corrected distance visual acuity (CDVA100) (logMAR) (High Contrast - 100%). |
| IOL Decentration | 1 day | The mean value and standard deviation of IOL decentration. |
| IOL Tilt | 1 day | The mean value and standard deviation of IOL tilt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UCDVA100 | 1 day | The mean between Uncorrected Distance Visual Acuity (UCDVA100) (logMAR) (High Contrast - 100%) |
| UCIVA100 | 1 day | The mean between Uncorrected Intermediate Visual Acuity (UCIVA100) (logMAR) (High Contrast - 100%). |
| DCIVA100 | 1 day | The mean between Distance Corrected Intermediate Visual Acuity (100%) (DCIVA100) (logMAR) (High Contrast - 100%). |
| MRSE | 1 day | The mean between Manifest Refraction Spherical Equivalent (MRSE) (D). |
Countries
United States
Participant flow
Pre-assignment details
Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| IOL Type Non-toric | 70 Participants |
| IOL Type Toric | 31 Participants |
| Pre-Op CDVA High-Contrast | 0.177 logMAR STANDARD_DEVIATION 0.166 |
| Pre-Op MRSE | -0.031 D STANDARD_DEVIATION 2.801 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 100 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
None listed