Status:
COMPLETED
Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study
Lead Sponsor:
Shammas Eye Medical Center
Collaborating Sponsors:
Sengi
Conditions:
Cataract
Eligibility:
All Genders
18+ years
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-operativel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 29 2025
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT06085131
Start Date
October 31 2023
End Date
January 29 2025
Last Update
January 30 2025
Active Locations (6)
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1
Colvard-Kandavel Eye Center
Encino, California, United States, 91316
2
Shammas Eye Medical Center
Lynwood, California, United States, 90262
3
Shammas Eye Center
Whittier, California, United States, 90602
4
Multack Eye Care, Sc
Frankfort, Illinois, United States, 60461