N/A
N=30
Tolerance to Residual Astigmatism in Eyes With Vivity®
Lenses, Intraocular
Bottom Line
View on ClinicalTrials.gov: NCT05392998 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Distance Against the Rule Astimatism — 0.01 LogMAR
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cataract surgery with Vivity intraocular lens implantation (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Clínica Rementería
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Against the Rule Astimatism |
0.01 | — |
| PRIMARY Distance Oblique Astigmatism |
0.01 | — |
| PRIMARY Distance With the Rule Astigmatism |
0.01 | — |
Summary
Low amounts of postoperative residual astigmatism may worsen the visual performance of patients implanted with presbyopia- correcting intraocular lenses (IOLs). Although extended depth of focus (EDoF) IOLS have introduced optical improvements, it is important to determine the tolerance of these IOLs to postoperative astigmatism. This is important for an appropriate surgical planning.
Therefore, the aim of this study is to simulate and assess the impact of mild amounts of residual mixed astigmatisms with the axis oriented in different positions (vertical, oblique and horizontal) in eyes implanted with the Vivity® IOL.
Eligibility Criteria
Inclusion Criteria
- Patients >40 years old that undergo routine cataract surgery
- Bilateral implantation of Vivity ® IOL
Exclusion Criteria
- Corneal astigmatism ≥1.0 diopters (D )
- Amblyopia
- Previous ocular surgery
- Presence of ocular pathologies
- Abnormal iris
- Patients with intra- or postoperative complications
- Postoperative best distance corrected visual acuity (BDCVA) 0.50D
Data sourced from ClinicalTrials.gov (NCT05392998). 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.