Visual Outcomes of Vivity in Patients With High Axial Length
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT05210569 ↗Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Vivity (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Dr. James J. Wiens Medical Corporation
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Uncorrected Distance Visual Acuity (logMAR) |
-0.1 | — |
| PRIMARY Binocular Uncorrected Intermediate Visual Acuity (logMAR) |
0.01 | — |
| PRIMARY Binocular Uncorrected Near Visual Acuity (logMAR) |
0.21 | — |
| SECONDARY Prediction Error |
35 | — |
| SECONDARY Binocular Corrected Distance Visual Acuity (logMAR) |
-0.14 | — |
| SECONDARY Binocular Distance Corrected Intermediate Visual Acuity (logMAR) |
-0.02 | — |
| SECONDARY Binocular Distance Corrected Near Visual Acuity (logMAR) |
0.18 | — |
| SECONDARY Monocular Corrected Distance Visual Acuity (logMAR) |
-0.09 | — |
| SECONDARY Monocular Distance Corrected Intermediate Visual Acuity (logMAR) |
0.05 | — |
| SECONDARY Monocular Distance Corrected Near Visual Acuity (logMAR) |
0.32 | — |
| SECONDARY Manifest Refraction Spherical Equivalent |
0.25 | — |
| SECONDARY Questionnaire |
2; 0; 2; 1; 0; 0 | — |
| SECONDARY Percentage of Participants With Spectacle Independence |
19; 18; 8 | — |
| SECONDARY Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR) |
0.05 | — |
Summary
Eligibility Criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Inclusion Criteria
- Undergoing uncomplicated bilateral cataract surgery with IOL implantation.
- Gender: Males and Females.
- Age: 50 years or older.
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and other study procedures.
- Motivated for greater degree of spectacle independence vs monofocal IOL.
- Axial length ≥24.5mm in both eyes.
- Planned cataract removal by femtosecond laser.
Exclusion Criteria
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Ocular comorbidity that might hamper postoperative visual acuity.
- Previous refractive surgery.
- Irregular corneal astigmatism.
- Evidence of keratoconus as per Pentacam.
- Expected post-op VA worse than 20/25 (Snellen).
- Refractive lens exchange.
- Difficulties comprehending written or spoken English language.
- Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
- Clinically significant or severe ocular surface disease that would affect study measurements based on the investigator's opinion.
- Axial length <24.5mm.
- Evidence of macular pathology as per optical coherence tomography examination.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Data sourced from ClinicalTrials.gov (NCT05210569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.