Comparison of Two Different Optical Biometric Systems

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Cataract, Presbyopia, Ocular Biometry, Intraocular Lens

Intervention / Treatment
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* Device: Argos (Alcon Laboratories, Inc.)
* Device: IOLMaster 500 (Carl Zeiss Meditec AG)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, presbyopia, argos, iol master 500, optical biometric system