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COMPLETED
NCT06377007
NA

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

Sponsor: Walailak University

View on ClinicalTrials.gov

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)

Official title: Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION): A Non-Inferiority Randomized Clinical Trials

Key Details

Gender

All

Age Range

40 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2024-05-01

Completion Date

2025-01-31

Last Updated

2026-05-15

Healthy Volunteers

No

Conditions

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.

Locations (1)

Walailak University

Nakhon Si Thammarat, Changwat Nakhon Si Thammarat, Thailand