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Argos Biometer for Cataract
N/A
Recruiting
Led By H J Shammas, MD
Research Sponsored by Shammas Eye Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months postoperative
Awards & highlights
Study 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-operatively, operatively and at 5-8 weeks postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and preoperative biometry.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.50 D.
Secondary outcome measures
The Mean Predictive Error and its standard deviation after constant personalization for the entire series.
The Mean Predictive Errors in the short eyes and in the long eyes
The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Argos BiometerExperimental Treatment1 Intervention
Preoperative biometry with the Argos device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Argos
2021
N/A
~80
Find a Location
Who is running the clinical trial?
Shammas Eye Medical CenterLead Sponsor
SengiIndustry Sponsor
19 Previous Clinical Trials
1,043 Total Patients Enrolled
11 Trials studying Cataract
561 Patients Enrolled for Cataract
H J Shammas, MDPrincipal InvestigatorShammes Eye Medical Center
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