Corneal Biomechanics, Optical Properties and Anterior Segment Structural Features in Patients With Pseudoexfoliation
CorPEX
A Comparative Study of Anterior Segment Structural Features, Biomechanical Behaviour and Optical Properties of the Cornea in Patients With and Without Pseudoexfoliation Syndrome.
1 other identifier
observational
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2024
CompletedFirst Posted
Study publicly available on registry
December 12, 2024
CompletedStudy Start
First participant enrolled
December 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedDecember 27, 2024
December 1, 2024
5 months
November 19, 2024
December 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (6)
Corneal biomechanics using Corvis Scheimpflug Technology
Baseline, during examination : approx. 1 hour
Optical quality measured by HD-analyzer : Strehl ratio
Baseline, during examination : approx. 1 hour
Optical quality measured by HD-analyzer : MTF cut-off
Baseline, during examination : approx. 1 hour
Corneal biomechanics using Corvis Scheimpflug Technology : velocity
Baseline, during examination : approx. 1 hour
Corneal biomechanics using Corvis Scheimpflug Technology : length
Baseline, during examination : approx. 1 hour
- +1 more secondary outcomes
Other Outcomes (8)
The level of agreement between the two optical density indicators (OSI, COD) after standardization
Baseline, during examination : approx. 1 hour
Anterior chamber depth (mm)
Baseline, during examination : approx. 1 hour
Endothelial cell density (cells/mm2)
Baseline, during examination : approx. 1 hour
- +5 more other outcomes
Study Arms (2)
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)
Interventions
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
Eligibility Criteria
Participants will be selected from patients who consult at the outpatient clinic of the 2nd Department of Ophthalmology, General Hospital Papageorgiou, Thessaloniki, Greece.
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
2nd Department of Ophthalmology, Papageorgiou General Hospital
Thessaloniki, 56429, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nikolaos Ziakas, Professor
Aristotle University Of Thessaloniki
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Ophthalmology
Study Record Dates
First Submitted
November 19, 2024
First Posted
December 12, 2024
Study Start
December 13, 2024
Primary Completion
May 1, 2025
Study Completion
May 1, 2025
Last Updated
December 27, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.
- Access Criteria
- 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.
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.