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

NCT06377007 | Completed

• 1 other identifier: WU66290
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Biometry; SS-OCT; IOLMaster700; Argos

Outcome Measures

Primary Outcomes (1)

• Mean absolute prediction error

  Mean absolute prediction error determining by the absolute disparity between the predicted spherical equivalent refraction derived from preoperative planning and the actual measured spherical equivalent refraction (manifest) from both devices (IOLMaster 700 and Argos)

  4 weeks

Secondary Outcomes (3)

• Proportion of eyes with absolute prediction error ≤ 0.25 D

  4 weeks

• Median absolute prediction error

  4 weeks

• Proportion of eyes within ±0.50 D of target refraction

  4 weeks

Study Arms (2)

IOLMaster 700

ACTIVE COMPARATOR

Patients allocated to this arm underwent biometric measurement with the IOLMaster 700 swept-source OCT biometer (Carl Zeiss Meditec AG). IOL power for the implanted TECNIS Monofocal one-piece IOL (model GCB00V) was calculated using the Barrett Universal II formula with total keratometry input (Barrett UII TK

Device: IOLMaster 700 (Carl Zeiss Meditec AG)

ARGOS

EXPERIMENTAL

Patients allocated to this arm underwent biometric measurement with the ARGOS swept-source OCT biometer, which uses segmental refractive indices for axial length measurement. IOL power for the implanted TECNIS Monofocal one-piece IOL (model GCB00V) was calculated using the standard Barrett Universal II formula with anterior keratometry input (Barrett UII K

Device: ARGOS (Movu/Santec; distributed by Alcon)

Interventions

IOLMaster 700 (Carl Zeiss Meditec AG) DEVICE

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.

IOLMaster 700

ARGOS (Movu/Santec; distributed by Alcon) DEVICE

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.

ARGOS

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 40-90 years presenting with visually significant age-related cataract scheduled for elective phacoemulsification with implantation of a TECNIS Monofocal one-piece IOL (model GCB00V).

You may not qualify if:

• Corneal astigmatism greater than 1.00 D on either device
• Central corneal thickness outside 490-600 µm
• Severe dry eye precluding reliable keratometry
• Rigid or soft contact lens wear within 2 months prior to evaluation
• Previous corneal refractive surgery or other corneal pathology
• Prior intraocular surgery (other than uneventful cataract surgery in the fellow eye)
• Clinically significant retinal pathology potentially affecting refractive outcome (e.g., epiretinal membrane, diabetic macular edema, advanced age-related macular degeneration)
• Intraoperative complications including posterior capsule rupture, vitreous loss, or zonular dehiscence
• Dense cataract that does not allow measurements with optical biometry
• Inability to attend follow-up

Sponsors & Collaborators

• Walailak University: lead

Study Sites (1)

Walailak University

Nakhon Si Thammarat, Changwat Nakhon Si Thammarat, 80160, Thailand

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

TH (1)