Refractive Accuracy of Argos in Conjunction With the Alco... | NCT05901597

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2023Actual

Primary Completion Date

Dec 2, 2025Actual

Completion Date

Dec 2, 2025Actual

First Submitted Date

Jun 2, 2023

First Submission Date that Met QC Criteria

Jun 2, 2023

First Posted Date

Jun 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 13, 2026Actual

Name	Class
Sengi	INDUSTRY

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Name	Type	Description	Arm Group Labels	Other Names
Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer	Device	Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Monocular refractive target accuracy	Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D.	10 Weeks postoperative

Secondary Outcomes

Measure	Description	Time Frame
Prediction error	Percentage of eyes within prediction errors (PE) of ± 0.25D, 0.75D, 1.0D	10 Weeks postoperative
Mean absolute prediction error		10 Weeks postoperative

Other Outcomes

Measure	Description	Time Frame
Uncorrected binocular visual acuity	at distance (6m), intermediate (60cm), and near (40cm)	10 Weeks postoperative
Satisfaction questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects presenting with age-related cataracts (or refractive lens exchange), and a motivation for spectacle independence.

Sampling Method

Non-Probability Sample

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases