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OpenTrials
Completed

NCT Number: NCT06085131

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Colvard-Kandavel Eye Center, Encino, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Argos

Device

Argos Biometer

Primary outcomes

  1. The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.50 D.

    Time frame: 2 months postoperative

Secondary outcomes

  1. The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D.

    Time frame: 2 months postoperative

  2. Mean Absolute Prediction Error (in Diopters)

    Time frame: 2 months postoperative

    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.

  3. 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

    Time frame: 2 months postoperative

    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.

Sponsors and collaborators

Lead sponsor

Shammas Eye Medical Center

Other

Collaborators

  • Sengi

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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