Assessment of Corneal Stiffness in Keratoconus After Crosslinking by Corvis ST and OCT.

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Brief Title

Assessment of Corneal Stiffness in Keratoconus After Crosslinking by Corvis ST and OCT.

Official Title

Assessment of Corneal Stiffness Parameters in Keratoconus After Corneal Collagen Cross Linking Using Dynamic Scheimpflug Technology and Anterior Segment Optical Coherence Tomography.

Brief Summary

      Objectives:

        -  Measurement of corneal stiffness parameters { Deformation Amlitude (DAR1), Integrated
           radius, Stress parameter (SP A1), Stress strain index (SSI) and Corvis biomechanical
           index (CBI) } in keratoconic corneas before and after 3 and 6 months CXL using Corvis
           ST.

        -  Measurement of demarcation line depth using anterior segment OCT and correlate between
           corneal stiffness following CXL and demarcation line depth.
    

Detailed Description

      Background and Rationale:

      Keratoconus is a progressive corneal degeneration resulting from noninflammatory thinning of
      the corneal stroma. Visual impairment typically commences in adolescence and progresses
      thereafter. Further increase in myopia, irregular astigmatism, and subepithelial scarring
      leads to visual impairment. Treatment modalities are based on refractive correction with
      spectacles or contact lenses to correct astigmatism and restore visual acuity. Such
      modalities do not stop ectatic progression and further visual deterioration, which ultimately
      necessitates corneal transplantation in 10% to 20% of patients.

      Corneal collagen cross-linking (CXL) has emerged as a promising techniq;ue to slow or halt
      the progression of keratoconus. CXL leads to an increase in intra and interfibrillar covalent
      bonds by photosensitized oxidation and causes a biomechanical stabilization of the cornea.

      Corneal visualization using dynamic Scheimpflug technology (Corvis ST, Oculus Optikger€ate
      GmbH) allows in vivo measurement of the corneal biomechanical deformation response to an
      applied air puff and is useful for evaluating the biomechanical response parameters of the
      cornea. It captures the dynamic corneal deformation caused by an air puff using an ultrahigh-
      speed camera that operates at a speed of greater than 4300 frames per second to capture a
      series of 140 sequential horizontal Scheimpflug images of the temporal-nasal cross section of
      the cornea. The consistency of the air puff has been shown and the spatial and temporal
      profiles have been characterized to allow calculation of the load on the cornea within the
      imaging window.

      The Corvis ST enables the measurement of several parameters by analyzing the timing and
      patterns of deformation at the highest concavity as well as applanation during inward
      deformation (loading) and outward recovery (unloading). The original parameters have been
      reported to be influenced most strongly by intraocular pressure (IOP) as well as age and
      central corneal thickness (CCT). Recently, new corneal biomechanical parameters were
      introduced, including the Deformation Amplitude ratio at 1.0 mm (DAR1), Deformation Amplitude
      ratio at 2.0 mm (DAR2), Integrated radius, Stiffness Parameter at first applanation (SP A1),
      Ambrosio's Relational Thickness (ARTH) , Corbic Biomechanical index (CBI) and biomechanically
      corrected IOP (bIOP).

      Laboratory studies have shown that the effective depth of CXL is confined to the anterior 300
      μm of the cornea. Moreover, a stromal demarcation line between treated and untreated stroma
      was visible biomicroscopically at a depth of approximately 300 μm over the entire cornea
      after CXL treatment. This demarcation line was also evident on optical coherence tomography
      (OCT). The depth of this line has been postulated as an indirect measurement of cross-linking
      effectiveness.
    


Study Type

Interventional


Primary Outcome

Measuring changes in corneal stiffness parameters in keratoconus after CXL by Corvis ST which measures corneal stiffness parameters.


Condition

Keratoconus

Intervention

Corvis ST (dynamic Scheimpflug technology)


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

55

Start Date

January 1, 2022

Completion Date

February 1, 2023

Primary Completion Date

January 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with documented progressive keratoconus within one year include any of the
             following:

        A. ≥ 1.00 diopter increase in maximal keratometry (Kmax). B. ≥ 1.00 diopter increase in the
        manifest cylinder. C. ≥ 0.75 diopter increase in average of Kmax and Kmin (Kmean). D. ≥ 2%
        decrease in central thickness. E. ≥ 1.50 diopter increase in the central K power from
        baseline. F. ≥ 1.0 diopter increase in manifest spherical equivalent change (MRSE).

          -  All patients have minimal corneal stromal thickness 400 μm before UVA irradiation.

        Exclusion Criteria:

          -  Patients with corneal rings.

          -  Advanced keratoconus with corneal scarring.

          -  History of herpetic keratitis and severe corneal infection.

          -  Pregnancy or breastfeeding.

          -  The use of rigid contact lens¬es for more than 4 weeks before the baseline evaluation.
      

Gender

All

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mohamed Fakhry, MD, 01222536367, [email protected]



Administrative Informations


NCT ID

NCT05161052

Organization ID

MD-80-2021


Responsible Party

Principal Investigator

Study Sponsor

Cairo University


Study Sponsor

Mohamed Fakhry, MD, Principal Investigator, Cairo University


Verification Date

December 2021