Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs

Launched by VALLEY LASER EYE CENTRE · Jun 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how accurately the Alcon Vision Suite, which includes a special device called the Argos biometer, can measure vision after patients receive certain types of lens implants for cataract surgery. The specific lenses being tested are called Clareon PanOptix and AcrySof Vivity, which are designed to reduce the need for glasses after surgery.

To be eligible for this study, participants must be at least 45 years old and have age-related cataracts. They should be motivated to reduce their reliance on glasses and have good eye health without other serious eye conditions. Participants will need to provide consent and attend scheduled visits throughout the study. If someone becomes pregnant during the study, their data may be excluded from effectiveness results, but they can still continue to participate. Overall, this trial aims to understand how well these technologies work together to improve vision after cataract surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects are eligible for the study if they meet the following criteria:
• • Note: Ocular criteria must be met in both eyes.
• • Age-related cataract surgery (or RLE) patients that select Clareon PanOptix or AcrySof Vivity IOL.
• • Gender: Males and Females.
• • Age: 45 or older.
• • Patients motivated to increase spectacle independence with relatively low incidence of visual phenomena.
• • 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.
• • Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error).
• 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 (any previous ocular surgery, any signs of retinal disease, or glaucoma etc.) that might hamper post-operative visual acuity.
• • Irregular corneal astigmatism and keratoconus.
• • Post refractive eyes (i.e. LASIK or PRK or SMILE).
• • Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
• • Angle Kappa/chord mu ≥0.6.
• • Higher order corneal aberrations: \> 0.6 total RMS, \>0.3 coma, \>0.3 trefoil (to exclude irregular corneas).
• • 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.