2nd Department of Ophthalmology, Papageorgiou General Hospital
Thessaloniki, 56429, Greece
Location status: Recruiting
NCT Number: NCT06731530
The purpose of this study is to assess the effect of pseudoexfoliation syndrome on corneal biomechanics, optical clarity of the cornea, and anterior segment structural features.
Interested in participating?
Request Info60 year–80 year
All sexes
Observational
Thessaloniki, 56429, Greece
Location status: Recruiting
A case group of patients with pseudoexfoliation syndrome will ungergo examinations to evaluate corneal optical properties (Pentacam-AXL, HD analyzer), biomechanics (Corvis ST) and anterior segment structural features (OCT-A Angiovue, Pentacam-AXL, IOLMaster V.5.4, Topcon SP-1P). The same examinations will be performed on a group of age-matched controls, and the results will be compared.
Corneal optical density will be assessed by backscatter measurement (COD, corneal optical density) using Pentacam AXL (Oculus, Wetzlar, Germany).
Corneal optical density will also be assessed by forward-scatter measurement (OSI, objective scatter index) using HD Analyzer (Visiometrics, Terassa, Spain, Keeler). The level of agreement between the two optical density indicators (OSI, COD) will be evaluated.
Corneal biomechanics measurements will be performed using Corvis Scheimpflug Technology. The main biomechanical parameter of the Corvis ST is DA (deformation amplitude). DA quantifies how the cornea deforms in response to an air puff and helps evaluate corneal stiffness and elasticity.
An additional objective is the study of structural parameters of the cornea as well as, more broadly, the anterior segment in pseudoexfoliation syndrome (PEX) patients, aiming to understand and describe the effects of PEX with the highest possible accuracy. Specifically, using the Pentacam-AXL (Oculus, Wetzlar, Germany), the IOLMaster V.5.4 (Carl Zeiss Meditec), the OCT-Angiography Angiovue (Optovue, Inc., Fremont, California, USA), and the specular microscope Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan), a comparative study will be conducted across a range of variables and maps: corneal topographic data, keratometric measurements, curvature radius data, pachymetric data, anterior chamber depth and volume, angle width, axial length, pupil diameter, and endothelial cell density. Some of these data, such as central corneal thickness, can be measured by two of the aforementioned devices. In this case, we will also attempt to evaluate the level of agreement between the two devices.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pentacam-AXL (Oculus, Wetzlar, Germany)
HD Analyzer (Visiometrics, Terassa, Spain, Keeler)
Corvis ST (Oculus, Germany)
OCT-A Angiovue (Optovue, Inc., Fremont, California, USA)
IOLMaster V.5.4 (Carl Zeiss., Meditec)
Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan)
BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus Examination
Time frame: Baseline, during examination : approx. 1 hour
Corneal optical density assessed by backscatter measurement (COD, corneal optical density) using Pentacam AXL (Oculus, Wetzlar, Germany)
Time frame: Baseline, during examination : approx. 1 hour
Corneal optical density assessed by forward-scatter measurement (OSI, objective scatter index) using HD Analyzer (Visiometrics, Terassa, Spain, Keeler)
Time frame: Baseline, during examination : approx. 1 hour
The main biomechanical parameter of the Corvis ST : DA (deformation amplitude). DA quantifies how the cornea deforms in response to an air puff and helps evaluate corneal stiffness and elasticity.
Time frame: Baseline, during examination : approx. 1 hour
Specific measurement variable: Total score of Strehl ratio; Value [no dimension];
Time frame: Baseline, during examination : approx. 1 hour
Specific measurement variable: Total score of Modulation transfer function (MTF) cut-off; Value [c/deg];
Time frame: Baseline, during examination : approx. 1 hour
Velocity during the first and the second applanation of the cornea, measured using Corvis ST [m/s]
Time frame: Baseline, during examination : approx. 1 hour
First and second applanation length (mm)
Time frame: Baseline, during examination : approx. 1 hour
Biomechanically corrected IOP (bIOP) (mmHg)
Time frame: Baseline, during examination : approx. 1 hour
The level of agreement between the two optical density indicators : objective scatter index (OSI), corneal optical density (COD) after standardization. Value [no dimension]
Time frame: Baseline, during examination : approx. 1 hour
Anterior chamber depth (mm)
Time frame: Baseline, during examination : approx. 1 hour
Endothelial cell density (cells/mm2)
Time frame: Baseline, during examination : approx. 1 hour
Corneal topography (D)
Time frame: Baseline, during examination : approx. 1 hour
Anterior chamber volume (mm3)
Time frame: Baseline, during examination : approx. 1 hour
Anterior chamber angle (°)
Time frame: Baseline, during examination : approx. 1 hour
Axial length (mm)
Time frame: Baseline, during examination : approx. 1 hour
Central corneal thickness (μm)
Contact information is provided by the study sponsor or research team.
Aristotle University Of Thessaloniki
Other
A Comparative Study of Anterior Segment Structural Features, Biomechanical Behaviour and Optical Properties of the Cornea in Patients With and Without Pseudoexfoliation Syndrome.
Acronym: CorPEX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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