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

NCT05748275 | Completed Results

• 1 other identifier: 64989743
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Mean Absolute Prediction Error (D)

  1 month postoperatively

Secondary Outcomes (2)

• Percentage of Eyes With Absolute Prediction Error 0.5 D or Less

  1 month postoperatively

• Median Absolute Prediction Error (D)

  1 month postoperatively

Study Arms (2)

Argos, Then IOLMaster 700

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

Diagnostic Test: Argos; Diagnostic Test: IOLMaster 700

IOLMaster 700, Then Argos

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

Diagnostic Test: Argos; Diagnostic Test: IOLMaster 700

Interventions

Argos DIAGNOSTIC_TEST

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

Argos, Then IOLMaster 700; IOLMaster 700, Then Argos

IOLMaster 700 DIAGNOSTIC_TEST

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

Argos, Then IOLMaster 700; IOLMaster 700, Then Argos

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults presenting with clinically significant cataracts.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Multack Eye Care: lead

Study Sites (1)

Multack Eye Care

Frankfort, Illinois, 60423, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Dr Sam Multack
• Organization: Multack Eye Care

smultack@mecvision.com

815-889-3333

Study Officials

• Sam Multack, D.O.

  Multack Eye Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 28, 2023
• Study Start: July 19, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)