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

Last updated: January 29, 2025
Sponsor: Shammas Eye Medical Center
Overall Status: Completed

Phase

N/A

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

Argos

Clinical Study ID

NCT06085131
HJS-23-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

  • Cataract surgery that was completed without complications with biometry measuredusing 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

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 principialinvestigator would influence the postoperative refraction.

  • Any disease or pathology, including but not limited to irregular corneal astigmatismand keratoconus, that is expected to reduce the potential postoperative BCDVA to alevel worse than 20/40.

  • Patients with history of previous ocular surgery.

  • Patients with signs of inability to understand consent for study and procedureplanned.

  • 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

Total Participants: 501
Treatment Group(s): 1
Primary Treatment: Argos
Phase:
Study Start date:
October 31, 2023
Estimated Completion Date:
January 29, 2025

Connect with a study center

  • Colvard-Kandavel Eye Center

    Encino, California 91316
    United States

    Site Not Available

  • Shammas Eye Medical Center

    Lynwood, California 90262
    United States

    Site Not Available

  • Shammas Eye Center

    Whittier, California 90602
    United States

    Site Not Available

  • Multack Eye Care, Sc

    Frankfort, Illinois 60461
    United States

    Site Not Available

  • Multack Eye Care, SC

    Olympia Fields, Illinois 60461
    United States

    Site Not Available

  • Juliette Eye Institute

    Albuquerque, New Mexico 87113
    United States

    Site Not Available

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