Comparison of Two Different Optical Biometric Systems

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411341
• Other study ID #: ES9/Th3/05-05-2022
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2024
• Source: Democritus University of Thrace
• Contact: Georgios Labiris, MD, PhD
• Phone: 00302551030405
• Email: labiris[@]usa.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Intraocular Lens
• Presbyopia

Intervention

Device:
• Argos (Alcon Laboratories, Inc.)
An ocular biometry examination will be performed on the affected eyes using the Argos device.
• IOLMaster 500 (Carl Zeiss Meditec AG)
An ocular biometry examination will be performed on the affected eyes using the IOL Master 500 device.

Locations

Country	Name	City	State
Greece	Department of Ophthalmology, University Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length	The measurement of the axial length of the affected eye using both devices	1 week
Primary	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
Primary	Lens power (D)	The power of the lens is calculated by each device as a function of biometric measurements	1 week
Secondary	Anterior chamber depth (ACD)	The measurement of the anterior chamber depth (ACD) of the affected eye using both devices.	1 week
Secondary	Horizontal corneal diameter (white to white [WTW])	The measurement of the horizontal corneal diameter of the affected eye using both devices.	1 week