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

Last updated: March 26, 2025
Sponsor: Valley Laser Eye Centre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Eye Disease

Eye Disorders/infections

Treatment

Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer

Clinical Study ID

NCT05901597
JB-23-01
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective is to assess refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation.

Eligibility Criteria

Inclusion

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 orAcrySof Vivity IOL.

  • Gender: Males and Females.

  • Age: 45 or older.

  • Patients motivated to increase spectacle independence with relatively low incidenceof 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 (outsideof residual refractive error).

Exclusion

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, orglaucoma 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'sDisease; unable to fixate).

  • Angle Kappa/chord mu ≥0.6.

  • Higher order corneal aberrations: > 0.6 total RMS, >0.3 coma, >0.3 trefoil (toexclude 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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer
Phase:
Study Start date:
May 09, 2023
Estimated Completion Date:
December 15, 2025

Study Description

This study is a single-arm, observational study of refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation. Subjects will be assessed at preoperatively, operatively, and 10 weeks post-operatively. Clinical evaluations will include measurement of monocular and binocular visual acuity, manifest refraction, and questionnaires will also be administered.

Connect with a study center

  • Valley Laser Eye Centre

    Abbotsford, British Columbia
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.