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

Vance Thompson Vision20 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cataract

Interventions

ARGOS BiometerDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vance Thompson Vision Clinic, Prof. LLC

Sioux Falls, South Dakota, United States

Outcomes

Primary Outcomes

Refractive Outcomes

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

Time frame: 12 weeks

Visual Outcomes

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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