Cataract
Conditions
Brief summary
To assess if the Alcon Argos Biometer utilizing the Barrett Universal II formula for IOL calculations can give a non-inferior outcome when compared to the Zeiss IOL master 700 utilizing the (PCA) with the Barrett Universal II (TK) formula, when comparing the (mean absolute prediction error of the predicted target spherical equivalencies).
Interventions
DIAGNOSTIC_TESTArgos
Biometry measurements first with the Argos device, then the IOLMaster 700 device.
DIAGNOSTIC_TESTIOLMaster 700
Biometry measurements first with the IOLMaster 700 device, then the Argos device.
Sponsors
Multack Eye Care
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Inclusion criteria
* Age: 50-85 years old * Clinically Significant Cataracts that interfere with daily activities * Patient is able to understand and able to consent to informed consent * Patient is able to come to all postoperative visits and agrees to follow up at 30 days -2/+14 days * Patient undergoing cataract surgery, with implantation of the Alcon SN60WF lens in the capsular bag.
Exclusion criteria
* Axial Length \< 22.00 and \> 26.00 * Corneal Astigmatism \> +1.00 Diopters * CCTS: \< 490 and \> 600 * Prior Refractive Surgery: RK, PRK, LASIK, INTACTS * History of contact lens use: Soft lenses within 2 months of surgery, RGP within 60 months of surgery * Corneal Disease: Keratoconus, Corneal Dystrophies, Any prior corneal Surgery, Prior infections * Retinal Disease: Macular Pathology, CSCR, CME, Macular Degeneration, Drusen, Retinal Detachment, TPPV, SB, prior IVT, Prior PRP or Focal Laser, Diabetic Retinopathy * History of Uveitis * POAG: Undergoing any concomitant MIGS procedure- iStent, Omni, iTrack, Hydrus, etc * Enrollment in any prior clinical trial within 2 years * Systemic Disease that in the investigator's opinion may affect outcome * Currently Pregnant or Breastfeeding * Severe Dry Eye * Tear Osmolarity \> 320mOsms/L (Moderate) * Any Surgical Complication(s) * IOL implanted outside of the capsular bag /capsular damage /weakness /CTR placement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Absolute Prediction Error (D) | 1 month postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Eyes With Absolute Prediction Error 0.5 D or Less | 1 month postoperatively |
| Median Absolute Prediction Error (D) | 1 month postoperatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | All Subjects | — |
|---|---|---|
| Age, Continuous | 72.2 years STANDARD_DEVIATION 6.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
Primary
Mean Absolute Prediction Error (D)
Time frame: 1 month postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Argos | Mean Absolute Prediction Error (D) | 0.21 diopters | Standard Deviation 0.25 |
| IOLMaster 700 | Mean Absolute Prediction Error (D) | 0.25 diopters | Standard Deviation 0.24 |
Secondary
Median Absolute Prediction Error (D)
Time frame: 1 month postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Argos | Median Absolute Prediction Error (D) | 0.14 diopters |
| IOLMaster 700 | Median Absolute Prediction Error (D) | 0.19 diopters |
Secondary
Percentage of Eyes With Absolute Prediction Error 0.5 D or Less
Time frame: 1 month postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argos | Percentage of Eyes With Absolute Prediction Error 0.5 D or Less | 91 percent |
| IOLMaster 700 | Percentage of Eyes With Absolute Prediction Error 0.5 D or Less | 88 percent |