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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-80
SponsorAristotle University Of Thessaloniki

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

Participants will be selected from patients who consult at the outpatient clinic of the 2nd Department of Ophthalmology, General Hospital Papageorgiou, Thessaloniki, Greece.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: PEX group (patients WITH pseudoexfoliation syndrome)7 interventions
Group B: Control group (patients WITHOUT pseudoexfoliation syndrome)7 interventions

Trial outcomes

Primary outcomes

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)

Time frame
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)

Time frame
Baseline, during examination : approx. 1 hour

Secondary outcomes

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.

Time frame
Baseline, during examination : approx. 1 hour
2

Optical quality measured by HD-analyzer : Strehl ratio

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

Time frame
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 \[c/deg\];

Time frame
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 \[m/s\]

Time frame
Baseline, during examination : approx. 1 hour

Other outcomes

1

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 \[no dimension\]

Time frame
Baseline, during examination : approx. 1 hour
2

Anterior chamber depth (mm)

Anterior chamber depth (mm)

Time frame
Baseline, during examination : approx. 1 hour
3

Endothelial cell density (cells/mm2)

Endothelial cell density (cells/mm2)

Time frame
Baseline, during examination : approx. 1 hour
4

Corneal topography (D)

Corneal topography (D)

Time frame
Baseline, during examination : approx. 1 hour

Sponsors and contacts

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Aristotle University Of Thessaloniki

Lead sponsor

Papageorgiou General Hospital

Collaborator