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

Completed

• Conditions: Cataract
• Interventions: Diagnostic Test: Argos; Diagnostic Test: IOLMaster 700

• Registration Number: NCT05748275
• Lead Sponsor: Multack Eye Care

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-19
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15
• Status Verified: 2023-02
• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-17
• Last Update Submitted: 2023-02-17
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Argos, Then IOLMaster 700	Argos	Biometry measurements first with the Argos device followed by the IOLMaster 700 device.
Argos, Then IOLMaster 700	IOLMaster 700	Biometry measurements first with the Argos device followed by the IOLMaster 700 device.
IOLMaster 700, Then Argos	Argos	Biometry measurements first with the IOLMaster 700 device followed by the Argos device.
IOLMaster 700, Then Argos	IOLMaster 700	Biometry measurements first with the IOLMaster 700 device followed by the Argos device.

Primary Outcome Measures

Name	Time	Method
Mean Absolute Prediction Error (D)	1 month postoperatively

Secondary Outcome Measures

Name	Time	Method
Percentage of Eyes With Absolute Prediction Error 0.5 D or Less	1 month postoperatively
Median Absolute Prediction Error (D)	1 month postoperatively

Trial Locations

Locations (1)

Multack Eye Care; 🇺🇸 Frankfort, Illinois, United States