Assessing the accuracy of a vision measurement system after cataract surgery

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

This study is testing how accurately a new vision measurement system works after cataract surgery to help people see better with their new lenses.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Valley Laser Eye Centre (Academic / other)
• Locations: 1 site (Abbotsford, British Columbia)
• Trial ID: NCT05901597 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the refractive accuracy of the Alcon Vision Suite, utilizing the Argos biometer, following the implantation of Clareon PanOptix and AcrySof Vivity intraocular lenses (IOLs) in patients undergoing cataract surgery. Participants will be assessed at various stages: preoperatively, during the procedure, and 10 weeks post-surgery. The study will involve clinical evaluations including measurements of visual acuity and manifest refraction, along with patient questionnaires to gather comprehensive data on outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 45 or older with age-related cataracts who are motivated to achieve greater independence from spectacles.

Not a fit: Patients with significant ocular comorbidities or previous ocular surgeries that could affect visual outcomes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the precision of vision correction following cataract surgery, leading to improved patient satisfaction and reduced dependence on glasses.

How similar studies have performed: Other studies have shown promising results in assessing refractive outcomes with similar methodologies, indicating a potential for success in this approach.

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:

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.

Where this trial is running

Abbotsford, British Columbia

• Valley Laser Eye Centre — Abbotsford, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: John Blaylock, MD — Valley Laser Eye Centre
• Study coordinator: Raeann Torrance

Conditions Cataract