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

Shammas Eye Medical Center

Status

Completed

Conditions

Cataract

Treatments

Device: Argos

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06085131

HJS-23-01

Details and patient eligibility

About

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.

Enrollment

501 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.