NCT05748275

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

Completed Results posted Last updated 19 September 2024

What this trial tests

trial testing Argos in Cataract in 80 participants. Completed in 15 September 2021.

Timeline

19 July 2021

Primary endpoint
15 September 2021

15 September 2021

Quick facts

Lead sponsor	Multack Eye Care
Status	Completed
Study type	OBSERVATIONAL
Enrollment	80
Start date	19 July 2021
Primary completion	15 September 2021
Estimated completion	15 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Argos
• IOLMaster 700

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Multack Eye Care

Who can join

Adults 50 to 85, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Absolute Prediction Error (D) Primary · 1 month postoperatively

Group	Value	95% CI
Argos	0.21	± 0.25
IOLMaster 700	0.25	± 0.24

Percentage of Eyes With Absolute Prediction Error 0.5 D or Less Secondary · 1 month postoperatively

Group	Value	95% CI
Argos	91
IOLMaster 700	88

Median Absolute Prediction Error (D) Secondary · 1 month postoperatively

Group	Value	95% CI
Argos	0.14	0.06 – 0.25
IOLMaster 700	0.19	0.09 – 0.29

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.