Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06085131

Enrollment

501

Registered

2023-10-16

Start date

2023-10-31

Completion date

2025-01-29

Last updated

2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

This study is a prospective, multi-site, multi-surgeon, observational study of refractive accuracy with the Argos using BTAL after successful cataract surgery. Subjects will be assessed pre-operatively, operatively and at 5-8 weeks postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and preoperative biometry.

Interventions

DEVICEArgos

Argos Biometer

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Subjects are eligible for the study if they meet the following criteria: * Cataract surgery that was completed without complications with biometry measured using the Argos biometer. * Subjects that elect Clareon SY60WF aspheric lens (Alcon, Fort Worth, TX). * Potential post-operative visual acuity of better than logMAR 0.30 (20/40). * BTAL was used to determine the IOL power implanted.

Exclusion criteria

If any of the following

Design outcomes

Primary

Measure	Time frame
The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.50 D.	2 months postoperative

Secondary

Measure	Time frame	Description
The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D.	2 months postoperative	—
The Mean Predictive Error and its standard deviation after constant personalization for the entire series.	2 months postoperative	—
The Mean Predictive Errors in the short eyes and in the long eyes	2 months postoperative	The Mean Predictive Errors in the short eyes and in the long eyes (Short AL\<22.5mm, Long AL \>24.5mm and Medium AL 22.6mm to 24.4mm), and the percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.25 D, ≤ ±0.50 D, ≤ ±0.75 D and ≤ ±1.00 D in each of these categories.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026