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

Recruiting

• Conditions: Cataract

• Registration Number: NCT05901597
• Lead Sponsor: Valley Laser Eye Centre

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.

Study Timeline

• Study Start: 2023-05-09
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Monocular refractive target accuracy	10 Weeks postoperative	Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D.

Secondary Outcome Measures

Name	Time	Method
Median absolute prediction error	10 Weeks postoperative
Back-calculated Residual Astigmatism (BRA)	10 Weeks postoperative	using preoperative cylinder power (for toric IOLs)
Distance corrected monocular visual acuity	10 Weeks postoperative	at distance (6m), intermediate (60cm), and near (40cm)
Prediction error	10 Weeks postoperative	Percentage of eyes within prediction errors (PE) of ± 0.25D, 0.75D, 1.0D
Uncorrected monocular visual acuity	10 Weeks postoperative	at distance (6m), intermediate (60cm), and near (40cm)
Manifest refraction	10 Weeks postoperative
Mean absolute prediction error	10 Weeks postoperative

Trial Locations

Locations (1)

Valley Laser Eye Centre; 🇨🇦 Abbotsford, British Columbia, Canada