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OpenTrials
Completed

NCT Number: NCT05748275

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

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).

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multack Eye Care

Frankfort, Illinois, 60423, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Argos

Diagnostic Test

Biometry measurements first with the Argos device, then the IOLMaster 700 device.

IOLMaster 700

Diagnostic Test

Biometry measurements first with the IOLMaster 700 device, then the Argos device.

Primary outcomes

  1. Mean Absolute Prediction Error (D)

    Time frame: 1 month postoperatively

Secondary outcomes

  1. Percentage of Eyes With Absolute Prediction Error 0.5 D or Less

    Time frame: 1 month postoperatively

  2. Median Absolute Prediction Error (D)

    Time frame: 1 month postoperatively

Sponsors and collaborators

Lead sponsor

Multack Eye Care

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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