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

NCT07129980 | Completed FDA Device

• 1 other identifier: ARGO-IIT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract

Keywords

Biometry, IOL Calculations

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Study Arms (1)

Study Participants

Eligible participants were subjects with a history of prior myopic corneal refractive surgery as confirmed by preoperative corneal topography and imaging. All subjects included in the study underwent traditional cataract surgery with a 2.4 millimeter (mm) corneal incision and were implanted with a standard monofocal intraocular lens. Following the procedure, subjects returned at 8-12 weeks postoperative for a study visit in which a manifest refraction was performed.

Device: ARGOS Biometer

Interventions

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.

Also known as: Swept Source Optical - Optical coherence tomography (SS-OCT)

Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or females undergoing uncomplicated cataract surgery with a history of myopic corneal laser refractive surgery and subjects electing to undergo implantation with a monofocal/non-toric IOL

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (1)

Vance Thompson Vision Clinic, Prof. LLC

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• John Berdahl, MD

  Vance Thompson Vision Clinic Prof. LLC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: July 11, 2023
• Primary Completion: July 3, 2025
• Study Completion: August 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)