Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- Monocular refractive target accuracy [10 Weeks postoperative]
Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D.
Secondary Outcome Measures
- 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)
Other Outcome Measures
- Uncorrected binocular visual acuity [10 Weeks postoperative]
at distance (6m), intermediate (60cm), and near (40cm)
- Satisfaction questionnaire [10 Weeks postoperative]
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.
- Visual disturbances questionnaire [10 Weeks postoperative]
Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.
- Percentage of cases in which IA IOL power recommendation differed from preop calculation [10 Weeks postoperative]
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
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Age-related cataract surgery (or RLE) patients that select Clareon PanOptix or AcrySof Vivity IOL.
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Gender: Males and Females.
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Age: 45 or older.
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Patients motivated to increase spectacle independence with relatively low incidence of visual phenomena.
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Willing and able to provide written informed consent for participation in the study.
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Willing and able to comply with scheduled visits and other study procedures.
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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.
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Ocular comorbidity (any previous ocular surgery, any signs of retinal disease, or glaucoma etc.) that might hamper post-operative visual acuity.
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Irregular corneal astigmatism and keratoconus.
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Post refractive eyes (i.e. LASIK or PRK or SMILE).
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Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
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Angle Kappa/chord mu ≥0.6.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Valley Laser Eye Centre | Abbotsford | British Columbia | Canada |
Sponsors and Collaborators
- Valley Laser Eye Centre
- Sengi
Investigators
- Principal Investigator: John Blaylock, MD, Valley Laser Eye Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JB-23-01