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

Multack Eye Care

Status: Completed

Conditions: Cataract

Treatments: Diagnostic Test: IOLMaster 700; Diagnostic Test: Argos

Study type: Observational

Funder types: Other

Identifiers

NCT05748275

64989743

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Argos, Then IOLMaster 700

Description:

Biometry measurements first with the Argos device followed by the IOLMaster 700 device.

Treatment:

Diagnostic Test: Argos

Diagnostic Test: IOLMaster 700

IOLMaster 700, Then Argos

Description:

Biometry measurements first with the IOLMaster 700 device followed by the Argos device.

Treatment:

Diagnostic Test: Argos

Diagnostic Test: IOLMaster 700