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

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

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Raeann Torrance; Phone Number: 604-504-3937; Email: raeann@vlec.ca

Study Locations

• Canada
  • British Columbia
    • Abbotsford, British Columbia, Canada
      • Recruiting
      • Valley Laser Eye Centre
      • Contact: Raeann Torrance; Email: raeann@vlec.ca
      • Principal Investigator: John Blaylock, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular refractive target accuracy	Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D.	10 Weeks postoperative

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected binocular visual acuity	at distance (6m), intermediate (60cm), and near (40cm)	10 Weeks postoperative
Satisfaction questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	10 Weeks postoperative
Visual disturbances questionnaire	Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.	10 Weeks postoperative
Percentage of cases in which IA IOL power recommendation differed from preop calculation		10 Weeks postoperative

Collaborators and Investigators

• Sponsor: Valley Laser Eye Centre
• Collaborators: Sengi
• Investigators: Principal Investigator: John Blaylock, MD, Valley Laser Eye Centre

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Estimated): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: JB-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes