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Completed
NCT05748275
Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers
Conditions: Cataract
Enrollment: 80
Sponsor: Multack Eye Care
Location: United States
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).
Eligibility Criteria
Inclusion Criteria:Age: 50-85 years oldClinically Significant Cataracts that interfere with daily activitiesPatient is able to understand and able to consent to informed consentPatient is able to come to all postoperative visits and agrees to follow up at 30 days -2/+14 daysPatient undergoing cataract surgery, with implantation of the Alcon SN60WF lens in the capsular bag.Exclusion Criteria:Axial Length < 22.00 and > 26.00Corneal Astigmatism > +1.00 DioptersCCTS: < 490 and > 600Prior Refractive Surgery: RK, PRK, LASIK, INTACTSHistory of contact lens use: Soft lenses within 2 months of surgery, RGP within 60 months of surgeryCorneal Disease: Keratoconus, Corneal Dystrophies, Any prior corneal Surgery, Prior infectionsRetinal Disease: Macular Pathology, CSCR, CME, Macular Degeneration, Drusen, Retinal Detachment, TPPV, SB, prior IVT, Prior PRP or Focal Laser, Diabetic RetinopathyHistory of UveitisPOAG: Undergoing any concomitant MIGS procedure- iStent, Omni, iTrack, Hydrus, etcEnrollment in any prior clinical trial within 2 yearsSystemic Disease that in the investigator's opinion may affect outcomeCurrently Pregnant or BreastfeedingSevere Dry EyeTear Osmolarity > 320mOsms/L (Moderate)Any Surgical Complication(s)IOL implanted outside of the capsular bag /capsular damage /weakness /CTR placement
Source: ClinicalTrials.gov (NCT05748275). StuddyBuddy aggregates publicly available trial information.