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Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION)

NCT06377007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-05-15

No results posted yet for this study

Summary

This prospective, single-centre, randomized, parallel-group comparative clinical study evaluated the refractive prediction accuracy of two swept-source optical coherence tomography (SS-OCT) biometers in a Thai cataract surgery cohort. The ARGOS biometer applies segmental refractive indices to individual ocular segments, whereas the IOLMaster 700 applies an equivalent refractive index to the whole eye. Each device is conventionally paired with a different keratometry-formula combination: ARGOS with the standard Barrett Universal II (Barrett UII K), and IOLMaster 700 with the Barrett Universal II using total keratometry (Barrett UII TK). The study compared these two device-formula pairings as they are used in routine clinical practice. Both biometers were performed on every eye on the same day, enabling a within-subject paired comparison of biometric agreement and refractive prediction error at one month after phacoemulsification cataract surgery with implantation of a TECNIS Monofocal one-piece IOL (model GCB00V)

Conditions

  • Cataract

Interventions

DEVICE

IOLMaster 700 (Carl Zeiss Meditec AG)

Preoperative biometric measurement using the IOLMaster 700 (software version 1.90.10). IOL power was calculated using the Barrett Universal II TK formula and used for power selection in this arm.

DEVICE

ARGOS (Movu/Santec; distributed by Alcon)

Preoperative biometric measurement using the ARGOS (software version A2.4). IOL power was calculated using the Barrett Universal II K formula and used for power selection in this arm.

Sponsors & Collaborators

  • Walailak University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06377007 on ClinicalTrials.gov