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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Argos

• Study Type: Observational
• Enrollment (Actual): 523

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91316
      • Colvard-Kandavel Eye Center
    • Lynwood, California, United States, 90262
      • Shammas Eye Medical Center
    • Whittier, California, United States, 90602
      • Shammas Eye Center
  • Illinois
    • Frankfort, Illinois, United States, 60461
      • Multack Eye Care, SC
    • Olympia Fields, Illinois, United States, 60461
      • Multack Eye Care, SC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87113
      • Juliette Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Eligible test subjects will be adults who are interested in and appropriate candidates for cataract surgery.

Description

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 exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Patients with pre-existing ocular pathology that in the opinion of the principial investigator would influence the postoperative refraction.
• Any disease or pathology, including but not limited to irregular corneal astigmatism and keratoconus, that is expected to reduce the potential postoperative BCDVA to a level worse than 20/40.
• Patients with history of previous ocular surgery.
• Patients with signs of inability to understand consent for study and procedure planned.
• Eyes with intraoperative or postoperative complications.
• Suboptimal surgical outcomes that are not related to the treatment plan, e.g. capsular tear, cystoid macular edema.
• Astigmatism >±0.75D.

Each 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Argos Biometer; Preoperative biometry with the Argos device	Device: Argos; Argos Biometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.50 D.	2 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D.		2 months postoperative
Mean Absolute Prediction Error (in Diopters)	Prediction error is the difference in diopters (D) between the prediction made by the BTAL or BUII preoperative planning formulas, and the measured postoperative refraction. A value closer to 0 is better.	2 months postoperative
Mean Absolute Prediction Error (in Diopters) in Eyes With Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm	The Mean Predictive Errors in Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm eyes. Prediction error is the difference in diopters (D) between the prediction made by the BTAL or BUII preoperative planning formulas, and the measured postoperative refraction. A value closer to 0 is better.	2 months postoperative

Collaborators and Investigators

• Sponsor: Shammas Eye Medical Center
• Collaborators: Sengi
• Investigators: Principal Investigator: H J Shammas, MD, Shammes Eye Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Actual): January 29, 2025
• Study Completion (Actual): January 29, 2025

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: HJS-23-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes