Cataract
Conditions
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.
Interventions
DEVICEClareon 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
Sponsors
Valley Laser Eye Centre
Sengi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular refractive target accuracy | 10 Weeks postoperative | Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction error | 10 Weeks postoperative | Percentage of eyes within prediction errors (PE) of ± 0.25D, 0.75D, 1.0D |
| Mean absolute prediction error | 10 Weeks postoperative | — |
| Median absolute prediction error | 10 Weeks postoperative | — |
| Uncorrected monocular visual acuity | 10 Weeks postoperative | at distance (6m), intermediate (60cm), and near (40cm) |
| Distance corrected monocular visual acuity | 10 Weeks postoperative | at distance (6m), intermediate (60cm), and near (40cm) |
| Manifest refraction | 10 Weeks postoperative | — |
| Back-calculated Residual Astigmatism (BRA) | 10 Weeks postoperative | using preoperative cylinder power (for toric IOLs) |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORJohn Blaylock, MD
Valley Laser Eye Centre
Outcome results
None listed