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| Name | Class |
|---|---|
| Papageorgiou General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentacam-AXL | Device | Pentacam-AXL (Oculus, Wetzlar, Germany) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal optical density assessed by backscatter measurement | Corneal optical density assessed by backscatter measurement (COD, corneal optical density) using Pentacam AXL (Oculus, Wetzlar, Germany) | Baseline, during examination : approx. 1 hour |
| Corneal optical density assessed by forward-scatter measurement | Corneal optical density assessed by forward-scatter measurement (OSI, objective scatter index) using HD Analyzer (Visiometrics, Terassa, Spain, Keeler) | Baseline, during examination : approx. 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal biomechanics using Corvis Scheimpflug Technology | 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. | Baseline, during examination : approx. 1 hour |
| Optical quality measured by HD-analyzer : Strehl ratio |
| Measure | Description | Time Frame |
|---|---|---|
| The level of agreement between the two optical density indicators (OSI, COD) after standardization | The level of agreement between the two optical density indicators : objective scatter index (OSI), corneal optical density (COD) after standardization. Value [no dimension] | Baseline, during examination : approx. 1 hour |
Inclusion Criteria:
Exclusion Criteria:
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Participants will be selected from patients who consult at the outpatient clinic of the 2nd Department of Ophthalmology, General Hospital Papageorgiou, Thessaloniki, Greece.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paraskevi Petridou, MD, MSc | Contact | 00306985565799 | evina_petridou@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikolaos Ziakas, Professor | Aristotle University Of Thessaloniki | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department of Ophthalmology, Papageorgiou General Hospital | Recruiting | Thessaloniki | 56429 | Greece |
Deidentified Individual Participant Data (IPD) that underline published results, along with related data dictionaries, will be available only to researchers who will provide a methodologically sound proposal, after acceptance of the proposed protocol by our Institution's IRB. Data requestors will need to sign a data access agreement. The study protocol and statistical analysis plan will also be available, if needed.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.
Available only to researchers who will provide a methodologically sound proposal, after acceptance of the proposed protocol by our Institution's IRB. Data requestors will need to sign a data access agreement.
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| HD Analyzer | Device | HD Analyzer (Visiometrics, Terassa, Spain, Keeler) |
|
| Corvis ST | Device | Corvis ST (Oculus, Germany) |
|
| OCT-A Angiovue | Device | OCT-A Angiovue (Optovue, Inc., Fremont, California, USA) |
|
| IOLMaster V.5.4 | Device | IOLMaster V.5.4 (Carl Zeiss., Meditec) |
|
| Topcon SP-1P | Device | Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan) |
|
| BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus examination | Other | BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus Examination |
|
Specific measurement variable: Total score of Strehl ratio; Value [no dimension]; |
| Baseline, during examination : approx. 1 hour |
| Optical quality measured by HD-analyzer : MTF cut-off | Specific measurement variable: Total score of Modulation transfer function (MTF) cut-off; Value [c/deg]; | Baseline, during examination : approx. 1 hour |
| Corneal biomechanics using Corvis Scheimpflug Technology : velocity | Velocity during the first and the second applanation of the cornea, measured using Corvis ST [m/s] | Baseline, during examination : approx. 1 hour |
| Corneal biomechanics using Corvis Scheimpflug Technology : length | First and second applanation length (mm) | Baseline, during examination : approx. 1 hour |
| Corneal biomechanics using Corvis Scheimpflug Technology : bIOP | Biomechanically corrected IOP (bIOP) (mmHg) | Baseline, during examination : approx. 1 hour |
| Anterior chamber depth (mm) |
Anterior chamber depth (mm) |
| Baseline, during examination : approx. 1 hour |
| Endothelial cell density (cells/mm2) | Endothelial cell density (cells/mm2) | Baseline, during examination : approx. 1 hour |
| Corneal topography (D) | Corneal topography (D) | Baseline, during examination : approx. 1 hour |
| Anterior chamber volume (mm3) | Anterior chamber volume (mm3) | Baseline, during examination : approx. 1 hour |
| Anterior chamber angle (°) | Anterior chamber angle (°) | Baseline, during examination : approx. 1 hour |
| Axial length (mm) | Axial length (mm) | Baseline, during examination : approx. 1 hour |
| Central corneal thickness (μm) | Central corneal thickness (μm) | Baseline, during examination : approx. 1 hour |
| ID | Term |
|---|---|
| D017889 | Exfoliation Syndrome |
| ID | Term |
|---|---|
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D066167 | Slit Lamp |
| ID | Term |
|---|---|
| D019721 | Ophthalmoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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