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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-31

Study Completion Date

2025-01-29

Brief Summary

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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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Detailed Description

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Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Argos Biometer

Preoperative biometry with the Argos device

Argos

Intervention Type DEVICE

Argos Biometer

Interventions

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Argos

Argos Biometer

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes