Cataract
Conditions
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-operatively, operatively and at 5-8 weeks postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and preoperative biometry.
Interventions
DEVICEArgos
Argos Biometer
Sponsors
Shammas Eye Medical Center
Sengi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.50 D. | 2 months postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D. | 2 months postoperative | — |
| Mean Absolute Prediction Error (in Diopters) | 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. |
| Mean Absolute Prediction Error (in Diopters) in Eyes With Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORH J Shammas, MD
Shammes Eye Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.6 years STANDARD_DEVIATION 7.23 |
| Sex: Female, Male Female | 316 Participants |
| Sex: Female, Male Male | 207 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 523 |
| other Total, other adverse events | 0 / 523 |
| serious Total, serious adverse events | 0 / 523 |
Outcome results
None listed