Comparison of Two Different Optical Biometric Systems

Assessment of Two Different Optical Biometric Systems, Based on Different Optical Technologies in Patients With Cataract or Presbyopia

Primary objective of this study is to evaluate and compare the measurements of two different optical biometrics systems in patients who will undergo cataract surgery or presbyopia surgery using intraocular lenses (IOL-PC).

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia; Intraocular Lens; Ocular Biometry
• Intervention / Treatment: Device: Argos (Alcon Laboratories, Inc.); Device: IOLMaster 500 (Carl Zeiss Meditec AG)

Detailed Description

This is a prospective study including patients visiting the outpatient Ophthalmology clinic of the University General Hospital of Alexandroupolis, who suffer from diagnosed cataract or presbyopia and are going to undergo implantation of intraocular lenses surgery. The patients will be fully informed about the procedure and the purpose of the study and a written informed consent will be provided by all participants. They will then undergo an ocular biometry examination using two optical biometric systems, Argos (Alcon Laboratories, Inc.) and IOLMaster 500 (Carl Zeiss Meditec AG). IOL Master 500 (Carl Zeiss Meditec AG) is a non-invasive optical biometer that uses partial coherence interferometry (PCI) with a wavelength of 780 nm to measure the AL of the eye. Argos (Alcon Laboratories, Inc.) is a novel non-invasive optical biometer that uses swept source optical coherence tomography (SS-OCT) with a wavelength of 1050 nm. The measurements of the two systems that will be compared are the axial length, the keratometry values, the anterior chamber depth (ACD), the horizontal corneal diameter (white to white [WTW]) and the lens power in diopters (D).

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandroupoli, Evros, Greece, 68100
      • Department of Ophthalmology, University Hospital of Alexandroupolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Adult patients with cataract and/or presbyopia.

Description

Inclusion Criteria:

• Patients with cataract and/or presbyopia who will undergo intraocular lens implantation.

Exclusion Criteria:

• Dense cataract that does not allow measurements to be taken with an optical biometrics system.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; 100 patients with diagnosed cataract or presbyopia who will undergo implantation of intraocular lenses surgery	Device: Argos (Alcon Laboratories, Inc.); An ocular biometry examination will be performed on the affected eyes using the Argos device.; Device: IOLMaster 500 (Carl Zeiss Meditec AG); An ocular biometry examination will be performed on the affected eyes using the IOL Master 500 device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	The measurement of the axial length of the affected eye using both devices	1 week
Keratometry values	The measurement of keratometry values K1: flat meridian of the anterior corneal surface and K2: steep meridian of the anterior corneal surface of the affected eye using both devices.	1 week
Lens power (D)	The power of the lens is calculated by each device as a function of biometric measurements	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior chamber depth (ACD)	The measurement of the anterior chamber depth (ACD) of the affected eye using both devices.	1 week
Horizontal corneal diameter (white to white [WTW])	The measurement of the horizontal corneal diameter of the affected eye using both devices.	1 week

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Investigators: Study Chair: Georgios Labiris, MD, PhD, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Publications and helpful links

General Publications

• Panagiotopoulou EK, Polychroniadis T, Bakirtzis M, Tsinopoulos I, Ziakas N, Labiris G. Level of Agreement of Intraocular Lens Power Measurements Between a Swept-Source OCT Biometer and a Partial Coherence Interferometer. J Clin Med. 2025 Jun 2;14(11):3903. doi: 10.3390/jcm14113903.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cataract; presbyopia; argos; iol master 500; optical biometric system
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Lens Diseases; Cataract; Presbyopia
• Other Study ID Numbers: ES9/Th3/05-05-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No