AzTrials
AzTrials

Pseudoexfoliation SyndromeCorPEXNCT06731530

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

An observational study of Pseudoexfoliation Syndrome and Biomechanical Parameters, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
What is being tested?
Pentacam-AXL, HD Analyzer and Corvis ST
Type of treatment
Medical device
How many people
86 participants
Where
1 siteGreece
Study dates
13 Dec 2024to May 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Paraskevi Petridou, MD, MSc contact

00306985565799

evina_petridou@hotmail.com

Greece1 site, 1 recruiting

  • 2nd Department of Ophthalmology, Papageorgiou General Hospital

    Thessaloniki, 56429

    Paraskevi Petridou, MD, MSc, 00306985565799, evina_petridou@hotmail.com

    Recruiting

Other trials in Greece

About this study

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.

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.

Read the 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.

Being tested
Pentacam-AXL, HD Analyzer, Corvis ST, OCT-A Angiovue, IOLMaster V.5.4
Keywords
pseudoexfoliation syndrome, biomechanical parameters, corneal transparency
Medical subject headings
Exfoliation Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pentacam-AXLDevice

    Pentacam-AXL (Oculus, Wetzlar, Germany)

  • HD AnalyzerDevice

    HD Analyzer (Visiometrics, Terassa, Spain, Keeler)

  • Corvis STDevice

    Corvis ST (Oculus, Germany)

  • OCT-A AngiovueDevice

    OCT-A Angiovue (Optovue, Inc., Fremont, California, USA)

  • IOLMaster V.5.4Device

    IOLMaster V.5.4 (Carl Zeiss., Meditec)

  • Topcon SP-1PDevice

    Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan)

  • BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus examinationOther

    BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus Examination

Study groups in NCT06731530
Study groupRoleWhat they receive
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)
Receives: Device: Pentacam-AXL; Device: HD Analyzer; Device: Corvis ST; Device: OCT-A Angiovue; Device: IOLMaster V.5.4; Device: Topcon SP-1P; Other: 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)
Receives: Device: Pentacam-AXL; Device: HD Analyzer; Device: Corvis ST; Device: OCT-A Angiovue; Device: IOLMaster V.5.4; Device: Topcon SP-1P; Other: BCVA (ETDRS), Slit lamp examination, Goldmann Applanation Tonometry, Fundus examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Corneal optical density assessed by backscatter measurement

    Corneal optical density assessed by backscatter measurement (COD, corneal optical density) using Pentacam AXL (Oculus, Wetzlar, Germany)

    Measured: Baseline, during examination : approx. 1 hour

  2. 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)

    Measured: Baseline, during examination : approx. 1 hour

Secondary outcomes (6)

  1. 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.

    Measured: Baseline, during examination : approx. 1 hour

  2. Optical quality measured by HD-analyzer : Strehl ratio

    Specific measurement variable: Total score of Strehl ratio; Value [no dimension];

    Measured: Baseline, during examination : approx. 1 hour

  3. Optical quality measured by HD-analyzer : MTF cut-off

    Specific measurement variable: Total score of Modulation transfer function (MTF) cut-off; Value [c/deg];

    Measured: Baseline, during examination : approx. 1 hour

  4. Corneal biomechanics using Corvis Scheimpflug Technology : velocity

    Velocity during the first and the second applanation of the cornea, measured using Corvis ST [m/s]

    Measured: Baseline, during examination : approx. 1 hour

  5. Corneal biomechanics using Corvis Scheimpflug Technology : length

    First and second applanation length (mm)

    Measured: Baseline, during examination : approx. 1 hour

  6. Corneal biomechanics using Corvis Scheimpflug Technology : bIOP

    Biomechanically corrected IOP (bIOP) (mmHg)

    Measured: Baseline, during examination : approx. 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start13 Dec 2024
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731530
Sponsor's protocol ID
36661
Acronym
CorPEX
Status last verified
Dec 2024
First submitted
19 Nov 2024
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Pseudoexfoliation Syndrome and Biomechanical Parameters, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paraskevi Petridou, MD, MSc (00306985565799, evina_petridou@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Corneal optical density assessed by backscatter measurement (time frame: Baseline, during examination : approx. 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06731530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in