Comparison of Two Different Optical Biometric Systems

NCT05411341 | Completed

• 1 other identifier: ES9/Th3/05-05-2022
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cataract; Presbyopia; Ocular Biometry; Intraocular Lens

Keywords

cataract; presbyopia; argos; iol master 500; optical biometric system

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Anterior chamber depth (ACD)

  1 week

• Horizontal corneal diameter (white to white [WTW])

  1 week

Study Arms (1)

Study Group

100 patients with diagnosed cataract or presbyopia who will undergo implantation of intraocular lenses surgery

Device: Argos (Alcon Laboratories, Inc.); Device: IOLMaster 500 (Carl Zeiss Meditec AG)

Interventions

Argos (Alcon Laboratories, Inc.) DEVICE

An ocular biometry examination will be performed on the affected eyes using the Argos device.

Study Group

IOLMaster 500 (Carl Zeiss Meditec AG) DEVICE

An ocular biometry examination will be performed on the affected eyes using the IOL Master 500 device.

Study Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with cataract and/or presbyopia.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (1)

• 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.

  PMID: 40507667 RESULT

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Georgios Labiris, MD, PhD

  Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) of Democritus University of Thrace

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: July 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

GR (1)