Comparison of Two Different Optical Biometric Systems

NCT ID: NCT05411341

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-08-31

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).

Conditions

Cataract; Presbyopia; Ocular Biometry; Intraocular Lens

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Group

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

Argos (Alcon Laboratories, Inc.)

Intervention Type: DEVICE

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

IOLMaster 500 (Carl Zeiss Meditec AG)

Intervention Type: DEVICE

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

Interventions

Argos (Alcon Laboratories, Inc.)

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

Intervention Type: DEVICE

IOLMaster 500 (Carl Zeiss Meditec AG)

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Democritus University of Thrace

OTHER

Sponsor Role: lead

Responsible Party

Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios Labiris, MD, PhD

Role: STUDY_CHAIR

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

Locations

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Georgios Labiris, MD, PhD

Role: CONTACT

labiris@usa.net

00302551030405

Eirini - Kanella Panagiotopoulou, MD

Role: CONTACT

eipanagi@med.duth.gr

00306978730858

Facility Contacts

Georgios Labiris, MD, PhD

Role: primary

glampiri@med.duth.gr

0030 2551030405

Eleftheria Chalkia

Role: backup

echalkia@med.duth.gr

00302551030405

Other Identifiers

ES9/Th3/05-05-2022

Identifier Type: -

Identifier Source: org_study_id