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NCT Number: NCT06731530

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

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Department of Ophthalmology, Papageorgiou General Hospital

Thessaloniki, 56429, Greece

Location status: Recruiting

Location contact

Paraskevi Petridou, MD, MSc

CONTACT

[email protected]

00306985565799

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pentacam-AXL

Device

Pentacam-AXL (Oculus, Wetzlar, Germany)

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

Primary outcomes

  1. Corneal optical density assessed by backscatter measurement

    Time frame: Baseline, during examination : approx. 1 hour

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

  2. Corneal optical density assessed by forward-scatter measurement

    Time frame: Baseline, during examination : approx. 1 hour

    Corneal optical density assessed by forward-scatter measurement (OSI, objective scatter index) using HD Analyzer (Visiometrics, Terassa, Spain, Keeler)

Secondary outcomes

  1. Corneal biomechanics using Corvis Scheimpflug Technology

    Time frame: Baseline, during examination : approx. 1 hour

    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.

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

    Time frame: Baseline, during examination : approx. 1 hour

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

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

    Time frame: Baseline, during examination : approx. 1 hour

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

  4. Corneal biomechanics using Corvis Scheimpflug Technology : velocity

    Time frame: Baseline, during examination : approx. 1 hour

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

  5. Corneal biomechanics using Corvis Scheimpflug Technology : length

    Time frame: Baseline, during examination : approx. 1 hour

    First and second applanation length (mm)

  6. Corneal biomechanics using Corvis Scheimpflug Technology : bIOP

    Time frame: Baseline, during examination : approx. 1 hour

    Biomechanically corrected IOP (bIOP) (mmHg)

Other outcomes

  1. The level of agreement between the two optical density indicators (OSI, COD) after standardization

    Time frame: Baseline, during examination : approx. 1 hour

    The level of agreement between the two optical density indicators : objective scatter index (OSI), corneal optical density (COD) after standardization. Value [no dimension]

  2. Anterior chamber depth (mm)

    Time frame: Baseline, during examination : approx. 1 hour

    Anterior chamber depth (mm)

  3. Endothelial cell density (cells/mm2)

    Time frame: Baseline, during examination : approx. 1 hour

    Endothelial cell density (cells/mm2)

  4. Corneal topography (D)

    Time frame: Baseline, during examination : approx. 1 hour

    Corneal topography (D)

  5. Anterior chamber volume (mm3)

    Time frame: Baseline, during examination : approx. 1 hour

    Anterior chamber volume (mm3)

  6. Anterior chamber angle (°)

    Time frame: Baseline, during examination : approx. 1 hour

    Anterior chamber angle (°)

  7. Axial length (mm)

    Time frame: Baseline, during examination : approx. 1 hour

    Axial length (mm)

  8. Central corneal thickness (μm)

    Time frame: Baseline, during examination : approx. 1 hour

    Central corneal thickness (μm)

Study contacts

Contact information is provided by the study sponsor or research team.

Paraskevi Petridou, MD, MSc

CONTACT

[email protected]

00306985565799

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Papageorgiou General Hospital

Registry information

Official study title

A Comparative Study of Anterior Segment Structural Features, Biomechanical Behaviour and Optical Properties of the Cornea in Patients With and Without Pseudoexfoliation Syndrome.

Acronym: CorPEX

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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