Corneal Biomechanics, Optical Properties and Anterior Segment Structural Features in Patients With Pseudoexfoliation
NCT ID: NCT06731530
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
86 participants
OBSERVATIONAL
2024-12-13
2025-05-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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PEX group (patients WITH pseudoexfoliation syndrome)
right or left eye of pseudophakic patients diagnosted with PEX syndrome pre-operatively (PEX positive, as recorded in the pre-operative medical file)
Pentacam-AXL
Pentacam-AXL (Oculus, Wetzlar, Germany)
HD Analyzer
HD Analyzer (Visiometrics, Terassa, Spain, Keeler)
Corvis ST
Corvis ST (Oculus, Germany)
OCT-A Angiovue
OCT-A Angiovue (Optovue, Inc., Fremont, California, USA)
IOLMaster V.5.4
IOLMaster V.5.4 (Carl Zeiss., Meditec)
Topcon SP-1P
Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan)
BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus examination
BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus Examination
Control group (patients WITHOUT pseudoexfoliation syndrome)
right or left eye of pseudophakic patients without a pre-operative diagnosis of pseudoexfoliation syndrome (PEX negative, as recorded in the pre-operative medical file)
Pentacam-AXL
Pentacam-AXL (Oculus, Wetzlar, Germany)
HD Analyzer
HD Analyzer (Visiometrics, Terassa, Spain, Keeler)
Corvis ST
Corvis ST (Oculus, Germany)
OCT-A Angiovue
OCT-A Angiovue (Optovue, Inc., Fremont, California, USA)
IOLMaster V.5.4
IOLMaster V.5.4 (Carl Zeiss., Meditec)
Topcon SP-1P
Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan)
BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus examination
BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus Examination
Interventions
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Pentacam-AXL
Pentacam-AXL (Oculus, Wetzlar, Germany)
HD Analyzer
HD Analyzer (Visiometrics, Terassa, Spain, Keeler)
Corvis ST
Corvis ST (Oculus, Germany)
OCT-A Angiovue
OCT-A Angiovue (Optovue, Inc., Fremont, California, USA)
IOLMaster V.5.4
IOLMaster V.5.4 (Carl Zeiss., Meditec)
Topcon SP-1P
Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan)
BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus examination
BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus Examination
Eligibility Criteria
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Inclusion Criteria
* unilateral or bilateral pseudophakia (cataract surgery undergone at Papageorgiou General Hospital, Thessaloniki, Greece).
* open anterior chamber angle (grade \> 2, van Herick method).
Exclusion Criteria
* 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
60 Years
80 Years
ALL
Yes
Sponsors
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Papageorgiou General Hospital
OTHER
Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Nikolaos Ziakas
Professor of Ophthalmology
Principal Investigators
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Nikolaos Ziakas, Professor
Role: STUDY_CHAIR
Aristotle University Of Thessaloniki
Locations
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2nd Department of Ophthalmology, Papageorgiou General Hospital
Thessaloniki, , Greece
Countries
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Central Contacts
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Facility Contacts
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Paraskevi Petridou, MD, MSc
Role: primary
Other Identifiers
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36661
Identifier Type: -
Identifier Source: org_study_id