Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers

Study Overview
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Brief Summary
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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).

Official Title
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Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers

Conditions
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Cataract

Intervention / Treatment
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* Diagnostic Test: Argos
* Diagnostic Test: IOLMaster 700


Participation Criteria
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Eligibility Criteria
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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

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Argos<br>Biometry measurements first with the Argos device followed by the IOLMaster 700 device. | Diagnostic Test: Argos<br>* Biometry measurements first with the Argos device, then the IOLMaster 700 device.<br>|
| IOLMaster 700<br>Biometry measurements first with the IOLMaster 700 device followed by the Argos device. | Diagnostic Test: IOLMaster 700<br>* Biometry measurements first with the IOLMaster 700 device, then the Argos device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean absolute prediction error (D) |  | 1 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |