Argos
DeviceArgos Biometer
NCT Number: NCT06085131
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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Notify Me18 year and older
All sexes
Observational
Colvard-Kandavel Eye Center, Encino, California, United States
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:
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.
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.
Argos Biometer
Time frame: 2 months postoperative
Time frame: 2 months postoperative
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.
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.
Shammas Eye Medical Center
Other
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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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