Comparison of Two Different Optical Biometric Systems
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Study Group 100 patients with diagnosed cataract or presbyopia who will undergo implantation of intraocular lenses surgery |
Device: Argos (Alcon Laboratories, Inc.)
An ocular biometry examination will be performed on the affected eyes using the Argos device.
Device: IOLMaster 500 (Carl Zeiss Meditec AG)
An ocular biometry examination will be performed on the affected eyes using the IOL Master 500 device.
|
Outcome Measures
Primary Outcome Measures
- 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.
- Lens power (D) [1 week]
The power of the lens is calculated by each device as a function of biometric measurements
Secondary Outcome Measures
- Anterior chamber depth (ACD) [1 week]
The measurement of the anterior chamber depth (ACD) of the affected eye using both devices.
- Horizontal corneal diameter (white to white [WTW]) [1 week]
The measurement of the horizontal corneal diameter of the affected eye using both devices.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Ophthalmology, University Hospital of Alexandroupolis | Alexandroupolis | Evros | Greece | 68100 |
Sponsors and Collaborators
- Democritus University of Thrace
Investigators
- Study Chair: Georgios Labiris, MD, PhD, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ES9/Th3/05-05-2022