Clinical trial NCT05901597: Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs
Official title: Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Lead sponsor: Valley Laser Eye Centre
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2023-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects presenting with age-related cataracts (or refractive lens exchange), and a motivation for spectacle independence.

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.

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.

Primary outcomes:
measure: Monocular refractive target accuracy
timeFrame: 10 Weeks postoperative
Secondary outcomes:
measure: Prediction error
timeFrame: 10 Weeks postoperative
measure: Mean absolute prediction error
timeFrame: 10 Weeks postoperative
measure: Median absolute prediction error
timeFrame: 10 Weeks postoperative
measure: Uncorrected monocular visual acuity
timeFrame: 10 Weeks postoperative
measure: Distance corrected monocular visual acuity
timeFrame: 10 Weeks postoperative
measure: Manifest refraction
timeFrame: 10 Weeks postoperative
measure: Back-calculated Residual Astigmatism (BRA)
timeFrame: 10 Weeks postoperative
Other outcomes:
measure: Uncorrected binocular visual acuity
timeFrame: 10 Weeks postoperative
measure: Satisfaction questionnaire
timeFrame: 10 Weeks postoperative
measure: Visual disturbances questionnaire
timeFrame: 10 Weeks postoperative
measure: Percentage of cases in which IA IOL power recommendation differed from preop calculation
timeFrame: 10 Weeks postoperative
Locations:
city: Abbotsford
country: Canada
facility: Valley Laser Eye Centre
state: British Columbia
Study officials:
affiliation: Valley Laser Eye Centre
name: John Blaylock, MD
role: PRINCIPAL_INVESTIGATOR
References: