Clinical Trials Directory

Trials / Completed

CompletedNCT07129980

Refractive and Visual Outcomes With the ARGOS Biometer In Eyes With a History of Refractive Surgery: ARGOS Study

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Vance Thompson Vision · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The study is to evaluate the visual and refractive outcomes in eyes with prior myopic refractive surgery undergoing cataract surgery for intraocular lens (IOL) power calculations.

Detailed description

This was a prospective, single-site, study evaluating the accuracy of the ARGOS biometer in subjects with a history of myopic corneal refractive surgery including Laser-Assisted In Situ Keratomileusis (LASIK) and Photorefractive Keratectomy (PRK).

Conditions

Interventions

TypeNameDescription
DEVICEARGOS BiometerThe ARGOS biometer uses swept-source optical coherence tomography (SS-OCT) with a 1060 nm tunable laser to capture high-resolution B-scan images of the entire eye. This technology enables sum-of-segments (S-O-S) biometry, measuring each ocular component-corneal thickness, aqueous depth, lens thickness, and vitreous length-individually and summing these values to determine total axial length. SS-OCT provides deep tissue penetration while simultaneously capturing keratometry, white-to-white, and pupillometry data in a single scan. For keratometry measurements, the ARGOS uniquely employes SS-OCT-based telecentric keratometry, which involves projection of 16 infrared LEDs in a wider 3.0 mm ring pattern onto the cornea and calculates curvature from those reflections.

Timeline

Start date
2023-07-11
Primary completion
2025-07-03
Completion
2025-08-01
First posted
2025-08-19
Last updated
2025-08-24

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07129980. Inclusion in this directory is not an endorsement.