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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vance Thompson Vision Clinic, Prof. LLC

Sioux Falls, South Dakota, 57108, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing uncomplicated cataract surgery with a history of myopic corneal laser refractive surgery
Subjects electing to undergo implantation with a monofocal/non-toric IOL
Willing and able to comprehend informed consent and complete an 8-week visit.
Potential postoperative Corrected Distance Visual Acuity (CDVA) of 20/20 or better in each eye based on Investigator's medical opinion

Exclusion criteria

Concurrent or prior ocular surgery within the previous 12 months.
Ocular comorbidity that could reduce the potential postoperative CDVA based on the discretion of the operating surgeon
History of hyperopic laser corneal refractive surgery
History of radial keratotomy
Irregular corneal astigmatism or keratoconus 6. Eyes with intraoperative or postoperative complications 7. Eyes with BCDVA worse than 20/100 preoperatively 8. Subjects who are pregnant or plan to become pregnant during the course of the study.

Treatment and study plan

ARGOS Biometer

Device

The 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.

Other names: Swept Source Optical - Optical coherence tomography (SS-OCT)

Primary outcomes

Refractive Outcomes

Time frame: 12 weeks

To evaluate refractive outcomes in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations.
Visual Outcomes

Time frame: 12 weeks

To evaluate visual in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations.

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Aug 19, 2025
Registry last updated: Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed