Corneal Biomechanical Changes of Allergic Conjunctivitis

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Brief Title

Corneal Biomechanical Changes of Allergic Conjunctivitis

Official Title

Corneal Biomechanical Changes and Related Risk Prediction in Allergic Conjunctivitis

Brief Summary

      By measuring and comparing the corneal biomechanical parameters of normal people, patients
      with allergic conjunctivitis, keratoconus, whether allergic conjunctivitis causes changes in
      corneal biomechanics can be explored, and sensitive mechanical indicators of allergic
      conjunctivitis can be identified. Furthermore, through rubbing frequency, ocular allergic
      symptom scores and physical sign scores observation, corneal morphological parameters,
      corneal epithelial thickness, tear inflammatory cytokines levels, and conjunctival
      microvascular parameters measurements, related factors affecting corneal biomechanics in
      patients with allergic conjunctivitis can be identified. Otherwise, by comparing corneal
      biomechanical changes in vernal keratoconjunctivitis before and after drug treatment,
      biomechanical change tendency during treatment can be clarified.
    

Detailed Description

      The current study involves 3 parts. The first part aims to explore whether allergic
      conjunctivitis causes changes in corneal biomechanics and to identify sensitive mechanical
      indicators of allergic conjunctivitis. This part is a cross-sectional study. Four groups are
      included: normal group, vernal keratoconjunctivitis (VKC) group, seasonal allergic
      conjunctivitis (SAC) group and keratoconus (KC) group, with 25 eyes in each group (in normal
      group one eye is randomly selected , and in VKC group, SAC group and KC group the more severe
      one is selected). Patients in all groups meet inclusion criteria and voluntarily join this
      study with informed consents. Medical history is collected, including basic information,
      allergic history and course of disease. Corneal biomechanics is measured by Corvis ST. The
      difference of corneal biomechanics among groups is analyzed to determine corneal
      biomechanical changes of AC and to find sensitive mechanical indicators of AC.

      The second part aims to identify related factors affecting corneal biomechanics in patients
      with allergic conjunctivitis. This part is also a cross-sectional study. Four groups are
      included: normal group, VKC group, SAC group and KC group, with 25 eyes in each group.
      Medical history is collected, including basic information, allergic history and course of
      disease. Eye rubbing frequency, ocular allergic symptom scores and physical sign scores are
      measured and recorded in VKC group and SAC group. Corneal biomechanics measured by Corvis ST,
      corneal morphological parameters measured by Pentacam, corneal epithelial thickness measured
      by Optovue OCT, tear cytokine levels measured by Milliplex kit and conjunctival microvascular
      parameters measured by functional slit lamp are performed in all patients. Correlation
      analysis of corneal biomechanical parameters and other measurement indicators in VKC group
      and SAC group is performed to determine the relevant influencing factors of corneal
      biomechanics in AC.

      The third part aims to determine corneal biomechanical change tendency during treatment in
      VKC. This part is a prospective case-control study. 25 patients with 25 eyes (the more severe
      eye is selected) are included. Medical history is collected, including basic information,
      allergic history and course of disease. Eye rubbing frequency, ocular allergic symptom scores
      and physical sign scores are measured and recorded in VKC group and SAC group. Corneal
      biomechanics measured by Corvis ST, corneal morphological parameters measured by Pentacam,
      corneal epithelial thickness measured by Optovue OCT, tear cytokine levels measured by
      Milliplex kit and conjunctival microvascular parameters measured by functional slit lamp are
      performed in all patients before drug treatment. And all the patients adopt a unified
      medication regimen. The same ophthalmological examinations are performed again after 3 month
      medication. Based on the analysis of the difference between the two measurements before and
      after the drug treatment, corneal biomechanical change tendency during treatment in VKC is
      clarified and the potential mechanical parameter needed to be monitored during follow-up is
      identified. The specific therapeutic regimen is as follows: 0.1% tacrolimus eye drops four
      times daily; 0.1% flumirone eye drops twice daily; azelastine hydrochloride eye drops four
      times daily; hyaluronic acid sodium eye drops four times daily. After 1M, 0.1% flumilone eye
      drops is replaced with 0.02% flumirone eye drops twice daily, and the rest of the medication
      remaines unchanged.
    


Study Type

Observational


Primary Outcome

Corneal biomechanics

Secondary Outcome

 Eye rubbing frequency

Condition

Conjunctivitis, Allergic


Study Arms / Comparison Groups

 nomal
Description:  Corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured, and comparative analysis of biomechanics with other groups will be performed.

Publications

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

Recruitment Information



Estimated Enrollment

100

Start Date

November 10, 2019

Completion Date

June 30, 2021

Primary Completion Date

May 31, 2021

Eligibility Criteria

        Normal group

        Inclusion Criteria:

          1. No abnormalities are found by slit lamp and Pentacam.

          2. Diopters: diopter of spherical: -6.0D~+3.0D, diopter of cylinder: -2.0D~+2.0D,
             spherical equivalent: -6.0D~+3.0D

          3. Best corrected visual acuity ≥ 1.0

        Exclusion Criteria:

          1. Patients diagnosed with other eye diseases other than refractive error.

          2. With a history of eye surgery or trauma.

          3. With systemic diseases such as immune diseases and connective tissue diseases.

          4. With a family history of keratoconus and glaucoma.

          5. Wear soft contact lens within 2 weeks or rigid contact lens within 1 month.

        SAC group

        Inclusion Criteria:

          1. Symptoms: Itching, foreign body sensation, increased discharge in conjunctival sac.
             And children may mainly show an increase in blinking frequency.

          2. Signs: conjunctival hyperemia, swelling, tarsal papillae.

          3. Medical history: seasonal onset

          4. Diopters: diopter of spherical: -6.0D~+3.0D, diopter of cylinder: -2.0D~+2.0D,
             spherical equivalent: -6.0D~+3.0D

          5. Best corrected visual acuity ≥ 0.8

        Exclusion Criteria:

          1. Corneal scar.

          2. Other active inflammatory diseases of the eye.

          3. With a history of eye surgery or trauma.

          4. With systemic diseases such as immune diseases and connective tissue diseases.

          5. Wear soft contact lens within 2 weeks or rigid contact lens within 1 month.

          6. Unable to fixate and cooperate.

        VKC group

        Inclusion Criteria:

          1. Symptoms: Itching, foreign body sensation, increased discharge in conjunctival sac.
             And children may mainly show an increase in blinking frequency.

          2. Signs: giant papillae on the upper tarsal conjunctiva and gelatinous infiltration of
             the limbus.

          3. Diopters: diopter of spherical: -6.0D~+3.0D, diopter of cylinder: -2.0D~+2.0D,
             spherical equivalent: -6.0D~+3.0D

          4. Best corrected visual acuity ≥ 0.8

        Exclusion Criteria:

        The same as SAC group.

        Keratoconus group

        Inclusion Criteria:

          1. With a history of myopia and astigmatism

          2. Best corrected visual acuity <1.0

          3. At least 1 positive sign of the following is found by slit lamp examination: thinning
             of the corneal stroma, a cone-shaped ectatic protrusion of the cornea, Fleischer ring
             and Vogt striae.

          4. Typical signs of corneal topography: central corneal power value of the anterior
             surface >47D, central inferior/superior dioptric asymmetry >3D (within 3mm), central
             dioptric asymmetry between two eyes >1D.

        Exclusion Criteria:

        The same as SAC group.
      

Gender

All

Ages

7 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jin Yuan, PhD, 86-018843014719, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04299399

Organization ID

2019045


Responsible Party

Principal Investigator

Study Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University


Study Sponsor

Jin Yuan, PhD, Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University


Verification Date

March 2020