Comparison of Two Different Optical Biometric Systems

Recruiting

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

• Registration Number: NCT05411341
• Lead Sponsor: Democritus University of Thrace

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).

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 Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Study Start: 2023-07-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2024-07-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	IOLMaster 500 (Carl Zeiss Meditec AG)	100 patients with diagnosed cataract or presbyopia who will undergo implantation of intraocular lenses surgery
Study Group	Argos (Alcon Laboratories, Inc.)	100 patients with diagnosed cataract or presbyopia who will undergo implantation of intraocular lenses surgery

Primary Outcome Measures

Name	Time	Method
Lens power (D)	1 week	The power of the lens is calculated by each device as a function of biometric measurements
Axial length	1 week	The measurement of the axial length of the affected eye using both devices
Keratometry values	1 week	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Ophthalmology, University Hospital of Alexandroupolis; 🇬🇷 Alexandroupolis, Evros, Greece