Clinical trial NCT06731530: Corneal Biomechanics, Optical Properties and Anterior Segment Structural Features in Patients With Pseudoexfoliation
Official title: A Comparative Study of Anterior Segment Structural Features, Biomechanical Behaviour and Optical Properties of the Cornea in Patients With and Without Pseudoexfoliation Syndrome.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pseudoexfoliation Syndrome
Biomechanical Parameters
Corneal Densitometry
Keywords: pseudoexfoliation syndrome
biomechanical parameters
corneal transparency
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Papageorgiou General Hospital
First posted: 2024-12-12
Enrollment: 86
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be selected from patients who consult at the outpatient clinic of the 2nd Department of Ophthalmology, General Hospital Papageorgiou, Thessaloniki, Greece.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* age 60-80 years.
* unilateral or bilateral pseudophakia (cataract surgery undergone at Papageorgiou General Hospital, Thessaloniki, Greece).
* open anterior chamber angle (grade \> 2, van Herick method).

Exclusion Criteria:

* History of intraocular surgery other than uncomplicated cataract surgery (phakoemulsification).
* Cataract surgery within the last 3 months.
* History of ocular trauma.
* Use of contact lenses.
* Corneal pathology.
* Use of anti-VEGF medications.
* History of uveitis or active uveitis.
* Hypertension (IOP \> 21 mmHg) or glaucoma.
* Myopia or hyperopia greater than 3 diopters.
* Astigmatism greater than 1.5 diopters.
* Posterior capsular opacification grade 2, 3, or 4 based on the EPCO grading scale.
* Tear break-up time \<10 sec

Primary outcomes:
measure: Corneal optical density assessed by backscatter measurement
timeFrame: Baseline, during examination : approx. 1 hour
measure: Corneal optical density assessed by forward-scatter measurement
timeFrame: Baseline, during examination : approx. 1 hour
Secondary outcomes:
measure: Corneal biomechanics using Corvis Scheimpflug Technology
timeFrame: Baseline, during examination : approx. 1 hour
measure: Optical quality measured by HD-analyzer : Strehl ratio
timeFrame: Baseline, during examination : approx. 1 hour
measure: Optical quality measured by HD-analyzer : MTF cut-off
timeFrame: Baseline, during examination : approx. 1 hour
measure: Corneal biomechanics using Corvis Scheimpflug Technology : velocity
timeFrame: Baseline, during examination : approx. 1 hour
measure: Corneal biomechanics using Corvis Scheimpflug Technology : length
timeFrame: Baseline, during examination : approx. 1 hour
measure: Corneal biomechanics using Corvis Scheimpflug Technology : bIOP
timeFrame: Baseline, during examination : approx. 1 hour
Other outcomes:
measure: The level of agreement between the two optical density indicators (OSI, COD) after standardization
timeFrame: Baseline, during examination : approx. 1 hour
measure: Anterior chamber depth (mm)
timeFrame: Baseline, during examination : approx. 1 hour
measure: Endothelial cell density (cells/mm2)
timeFrame: Baseline, during examination : approx. 1 hour
measure: Corneal topography (D)
timeFrame: Baseline, during examination : approx. 1 hour
measure: Anterior chamber volume (mm3)
timeFrame: Baseline, during examination : approx. 1 hour
measure: Anterior chamber angle (°)
timeFrame: Baseline, during examination : approx. 1 hour
measure: Axial length (mm)
timeFrame: Baseline, during examination : approx. 1 hour
measure: Central corneal thickness (μm)
timeFrame: Baseline, during examination : approx. 1 hour
Locations:
city: Thessaloniki
country: Greece
facility: 2nd Department of Ophthalmology, Papageorgiou General Hospital
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Nikolaos Ziakas, Professor
role: STUDY_CHAIR
References: