Evaluation of the Keratoconic Cornea After Corneal Collagen Cross Linking.

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Brief Title

Evaluation of the Keratoconic Cornea After Corneal Collagen Cross Linking.

Official Title

The Role of Anterior Segment Optical Coherence Tomography in Evaluation of the Keratoconic Cornea After Corneal Collagen Cross Linking.

Brief Summary

      Aim of work:

        -  To detect abnormal corneal thinning in keratoconus using pachymetry maps measured by
           high-speed anterior segment optical coherence tomography (OCT).

        -  To evaluate the visualization and depth of the demarcation line with anterior segment
           optical coherence tomography (AS-OCT) after corneal collagen cross-linking (CXL).

        -  To compare the depth of demarcation line between epithelial-on (Epi-on) and
           epithelial-off (Epi-off) corneal collagen cross-linking.
    

Detailed Description

      Keratoconus is a bilateral, asymmetric, progressive, non-inflammatory corneal ectatic
      disorder that is characterized by progressive thinning, steepening and potential scaring.
      Usually it affects the inferior or central cornea that becomes thinner and bulges forward in
      a cone-shaped fashion, inducing irregular astigmatism and myopia and reducing the quality of
      vision. Approximately 50% of clinically normal fellow eyes will progress to KC within 16
      years. The greatest risk is during the first 6 years of the onset.

      Annual incidence of KC also varies greatly from 0.002% , to 0.23% of 100,000 population per
      year. Most of the western studies support the lower figure of 0.002% , while in the
      Middle-East it is about 0.02 per year. In the middle-East, there is about ten-fold higher
      incidence (0.02% compared to 0.002%), and ten-fold higher prevalence (2.34% compared to
      0.23%), as compared to Western counries.

      Management of keratoconus depends on a variety of factors including visual acuity, the degree
      of corneal thinning and steepening. Rigid gas permeable contact lenses (RGPs) have been tried
      to correct corneal irregularity and astigmatism in keratoconus but they don't stop
      keratoconus progression. Corneal collagen cross linking (CXL) is now considered as the
      treatment of choice in mild to moderate cases of keratoconus and is proven to halt the
      disease progression. The implantation of intrastromal corneal ring segments (e.g. INTACS,
      Ferrara & Keraring) has been indicated for cases with moderate keratoconus to flatten the
      steep irregular corneas. Advanced cases of keratoconus with marked deterioration of vision or
      corneal scarring may be good candidates for deep anterior lamellar or penetrating
      Keratoplasty (DALK or PKP).

      Collagen cross-linking (CXL) is a relatively new conservative approach for progressive
      corneal ectasia, which is able to strengthen corneal tissue reforming new covalent bonds.
      This strategy is based on the underlying pathology of the disease. Corneal collagen cross
      linking (CXL) idea was based on the fact that a photosensitizer substance like riboflavin
      (vitamin B2) can interact with ultraviolet irradiation (Ultraviolet-A) to strengthen the
      corneal tissue inter and intrafibrillar collagen bonds thus preventing further thinning,
      corneal protrusion and reduces corneal irregular astigmatism.

      Epithelial debridement enhances riboflavin corneal penetration that allows absorption of wide
      range of light spectrum wave lengths including ultra violet A.

      The idea of trans-epithelial delivery (Epi-on technique) of riboflavin into the corneal
      tissue was hindered by the fact that riboflavin can't penetrate intact corneal epithelium.
      The addition of certain molecules such as trometamol allows penetration of riboflavin into
      the corneal stroma that markedly reduces the possible complications of removing of the
      corneal epithelium (Epi-off technique) such as persistent epithelial defects, scarring and
      serious infectious keratitis. Another advantage of trans-epithelial CXL that it reduces the
      cytotoxic effects of ultraviolet irradiation on corneal endothelium and intraocular
      structures especially in thin corneas less than 400 um.

      Recently, CXL techniques were developed to minimize ultraviolet exposure and shorten the time
      of the procedure on basis of photochemical reciprocity in which increased irradiation
      intensity with reduced intervals achieve the same effect of the conventional cross linking
      techniques.

      Corneal collagen cross linking induces stromal collagen fiber shrinkage. Ultraviolet A
      exposure enhances covalent bond formation between collagen fibers especially in the anterior
      stroma where 65% of ultraviolet irradiation is absorbed within first 250 um thus a
      hyperrefelctive transitional area can be detected between the anterior cross linked and the
      posterior untreated corneal stromal tissue referred to as a demarcation line that is usually
      evident 1 - 6 months after CXL procedure.

      A comprehensive slit lamp examination could detect the demarcation line; however anterior
      segment ocular coherence tomography (AS-OCT) is a more sensitive tool to assess the extent
      and depth of a stromal demarcation line that is deeper centrally than peripherally due to the
      natural corneal curvature.

      Several studies confirm the effectiveness and safety of conventional cross-linking procedure,
      which is also known as "Dresden protocol", in which the interaction between 0.1% riboflavin
      molecules absorbed in corneal tissue and UV-A rays delivered at 3 mW/cm2 for 30 minutes (5.4
      J/cm2 energy dose) releases reactive oxygen species that promote the formation of "molecular
      bridges" between and within collagen fibers.

      Corneal cross-linking causes a dose-dependent keratocytes damage. Wollensak et al. described
      cellular apoptosis to a depth of 300 µm radiating with UV- A at 3 mW/cm2. Histopathological
      studies showed an already complete keratocyte apoptosis limited to the anterior stroma within
      24 hours. Some authors characterized the corneal stromal DL as a clinical sign to evaluate
      the depth of the CXL treatment.

      Some studies hypothesize the role of the DL after CXL depth as representative of CXL
      effectiveness. Recently, the essential debate focused on whether the depth of the corneal
      stromal DL is indeed a true indicator of CXL efficacy. The main question is whether "the
      deeper, the better" principle can be applied to CXL.

      In recent years, anterior segment optical coherence tomography (AS-OCT) and confocal
      microscopy have been used as tools to assess the depth of DL and consequently the depth of
      the cross-linking effect. By using the AS-OCT, the stromal DL is detected within an enhanced
      image of the cornea in the horizontal meridian. The image is captured when the corneal reflex
      is visible, and the depth of DL is measured using the caliper tool provided by the
      manufacturer. Doors et al described the best visibility of corneal stromal DL using AS-OCT at
      1 month after CXL treatment, with an average DL depth of 313 µm; Yam et al measured the depth
      of DL at 6 months highlighting that the severity of ectasia and age may cause a worse DL
      visibility.
    


Study Type

Interventional


Primary Outcome

Demarcation line (DL) depth

Secondary Outcome

 Change in visual acuity

Condition

Keratoconus

Intervention

Accelerated corneal collagen cross linking

Study Arms / Comparison Groups

 Group 1 (Epithelium-off accelerated CXL)
Description:  patients with corneal thickness > 400 µm (thinnest location) were assigned into Epi-off accelerated CXL procedure

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

Procedure

Estimated Enrollment

44

Start Date

October 1, 2016

Completion Date

May 30, 2019

Primary Completion Date

April 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with progressive keratoconus (maximum K-reading between 46 diopters and 56
             diopters), clear cornea and corneal pachymetry > 380um.

        Exclusion Criteria:

          -  Corneal scarring.

          -  Advanced keratoconus (k-max > 56 D).

          -  Corneal pachymetry (thinnest location) < 380 µm.

          -  Epithelial healing disorders e.g.

          -  Recurrent corneal erosion syndrome.

          -  History of diseases that may delay corneal healing or predispose the eye for future
             complications (e.g. rheumatic disorders, glaucoma, uveitis, chemical burn, corneal
             dystrophy).

          -  History suggestive of herpetic keratitis because the UVR can activate herpes virus.

          -  Post-LASIK ectasia and/or previous corneal surgeries e.g. intrastromal corneal ring
             segments (INTACS).

          -  Pregnancy and breast-feeding.
      

Gender

All

Ages

15 Years - 36 Years

Accepts Healthy Volunteers

No

Contacts

Kamel Abdelnaser, MD, 00201064848401, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT03879421

Organization ID

TROASOCTIEOTKCACCCL


Responsible Party

Sponsor-Investigator

Study Sponsor

Reham Mahmoud Abdelrahman


Study Sponsor

Kamel Abdelnaser, MD, Study Chair, Assiut University


Verification Date

March 2019