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

February 17, 2023 updated by: Multack Eye Care
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Frankfort, Illinois, United States, 60423
        • Multack Eye Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adults presenting with clinically significant cataracts.

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Argos
Biometry measurements first with the Argos device followed by the IOLMaster 700 device.
Diagnostic test: Argos
Biometry measurements first with the Argos device, then the IOLMaster 700 device.
IOLMaster 700
Biometry measurements first with the IOLMaster 700 device followed by the Argos device.
Diagnostic test: IOLMaster 700
Biometry measurements first with the IOLMaster 700 device, then the Argos device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean absolute prediction error (D)
Time Frame: 1 month postoperatively
1 month postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of eyes with absolute prediction error 0.5 D or less
Time Frame: 1 month postoperatively
1 month postoperatively
Median absolute prediction error (D)
Time Frame: 1 month postoperatively
1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Multack Eye Care

Investigators

  • Principal Investigator: Sam Multack, D.O., Multack Eye Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2021

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Estimate)

February 28, 2023

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64989743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on Argos

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe