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

Completed

• Conditions: Cataract
• Interventions: Device: Argos

• Registration Number: NCT06085131
• Lead Sponsor: Shammas Eye Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-16
• Study Start: 2023-10-31
• Status Verified: 2025-01
• Primary Completion: 2025-01-29
• Study Completion: 2025-01-29
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Argos Biometer	Argos	Preoperative biometry with the Argos device

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D.	2 months postoperative

Trial Locations

Locations (6)

Colvard-Kandavel Eye Center; 🇺🇸 Encino, California, United States

Shammas Eye Medical Center; 🇺🇸 Lynwood, California, United States

Shammas Eye Center; 🇺🇸 Whittier, California, United States

Multack Eye Care, Sc; 🇺🇸 Frankfort, Illinois, United States

Multack Eye Care, SC; 🇺🇸 Olympia Fields, Illinois, United States

Juliette Eye Institute; 🇺🇸 Albuquerque, New Mexico, United States