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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05901597
• Other study ID #: JB-23-01
• Status: Recruiting
• Start date: May 9, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: June 2023
• Source: Valley Laser Eye Centre
• Contact: Raeann Torrance
• Phone: 604-504-3937
• Email: raeann[@]vlec.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• Clareon 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

Locations

Country	Name	City	State
Canada	Valley Laser Eye Centre	Abbotsford	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Valley Laser Eye Centre	Sengi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Uncorrected binocular visual acuity	at distance (6m), intermediate (60cm), and near (40cm)	10 Weeks postoperative
Other	Satisfaction questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	10 Weeks postoperative
Other	Visual disturbances questionnaire	Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.	10 Weeks postoperative
Other	Percentage of cases in which IA IOL power recommendation differed from preop calculation		10 Weeks postoperative
Primary	Monocular refractive target accuracy	Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D.	10 Weeks postoperative
Secondary	Prediction error	Percentage of eyes within prediction errors (PE) of ± 0.25D, 0.75D, 1.0D	10 Weeks postoperative
Secondary	Mean absolute prediction error		10 Weeks postoperative
Secondary	Median absolute prediction error		10 Weeks postoperative
Secondary	Uncorrected monocular visual acuity	at distance (6m), intermediate (60cm), and near (40cm)	10 Weeks postoperative
Secondary	Distance corrected monocular visual acuity	at distance (6m), intermediate (60cm), and near (40cm)	10 Weeks postoperative
Secondary	Manifest refraction		10 Weeks postoperative
Secondary	Back-calculated Residual Astigmatism (BRA)	using preoperative cylinder power (for toric IOLs)	10 Weeks postoperative