NCT06731530

Corneal Biomechanics, Optical Properties and Anterior Segment Structural Features in Patients With Pseudoexfoliation

A Comparative Study of Anterior Segment Structural Features, Biomechanical Behaviour and Optical Properties of the Cornea in Patients With and Without Pseudoexfoliation Syndrome.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 86 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Pseudoexfoliation Syndrome
• Biomechanical Parameters
• Corneal Densitometry

Interventions

Type	Name	Description
DEVICE	Pentacam-AXL	Pentacam-AXL (Oculus, Wetzlar, Germany)
DEVICE	HD Analyzer	HD Analyzer (Visiometrics, Terassa, Spain, Keeler)
DEVICE	Corvis ST	Corvis ST (Oculus, Germany)
DEVICE	OCT-A Angiovue	OCT-A Angiovue (Optovue, Inc., Fremont, California, USA)
DEVICE	IOLMaster V.5.4	IOLMaster V.5.4 (Carl Zeiss., Meditec)
DEVICE	Topcon SP-1P	Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan)
OTHER	BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus examination	BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus Examination

Timeline

• Start date: 2024-12-13
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-12-12
• Last updated: 2024-12-27

Locations

1 site across 1 country: Greece