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

NCT05901597 | Completed FDA Device

• 1 other identifier: JB-23-01
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Monocular refractive target accuracy

  Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D.

  10 Weeks postoperative

Secondary Outcomes (7)

• Prediction error

  10 Weeks postoperative

• Mean absolute prediction error

  10 Weeks postoperative

• Median absolute prediction error

  10 Weeks postoperative

• Uncorrected monocular visual acuity

  10 Weeks postoperative

• Distance corrected monocular visual acuity

  10 Weeks postoperative

Other Outcomes (4)

• Uncorrected binocular visual acuity

  10 Weeks postoperative

• Satisfaction questionnaire

  10 Weeks postoperative

• Visual disturbances questionnaire

  10 Weeks postoperative

Interventions

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

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting with age-related cataracts (or refractive lens exchange), and a motivation for spectacle independence.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valley Laser Eye Centre: lead
• Sengi: collaborator

Study Sites (1)

Valley Laser Eye Centre

Abbotsford British Columbia, British Columbia, Canada

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• John Blaylock, MD

  Valley Laser Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 13, 2023
• Study Start: May 9, 2023
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)