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

Sponsor
Multack Eye Care (Other)
Overall Status
Completed
CT.gov ID
NCT05748275
Collaborator
(none)
80
Enrollment
1
Location
1.9
Actual Duration (Months)
42
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Argos
  • Diagnostic Test: IOLMaster 700

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers
Actual Study Start Date :
Jul 19, 2021
Actual Primary Completion Date :
Sep 15, 2021
Actual Study Completion Date :
Sep 15, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Mean absolute prediction error (D) [1 month postoperatively]

Secondary Outcome Measures

  1. Percentage of eyes with absolute prediction error 0.5 D or less [1 month postoperatively]

  2. Median absolute prediction error (D) [1 month postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Multack Eye Care Frankfort Illinois United States 60423

Sponsors and Collaborators

  • Multack Eye Care

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Multack Eye Care
ClinicalTrials.gov Identifier:
NCT05748275
Other Study ID Numbers:
  • 64989743
First Posted:
Feb 28, 2023
Last Update Posted:
Feb 28, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Feb 28, 2023