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

NCT ID: NCT05901597

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2025-12-15

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.

Detailed 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.

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

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

Intervention Type: DEVICE

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

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Valley Laser Eye Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Blaylock, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Laser Eye Centre

Locations

Valley Laser Eye Centre

Abbotsford, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Raeann Torrance

Role: CONTACT

raeann@vlec.ca

604-504-3937

Facility Contacts

Raeann Torrance

Role: primary

raeann@vlec.ca

Other Identifiers

JB-23-01

Identifier Type: -

Identifier Source: org_study_id