NCT04299399

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

March 3, 2020

Last Update Submit

March 3, 2020

Conditions

Conjunctivitis, AllergicKeratoconus

Keywords

Allergic conjunctivitisCorneal biomechanicsKeratoconus

Outcome Measures

Primary Outcomes (1)

  • Corneal biomechanics

    The corneal biomechanics parameters are measure by Corvis ST, including A1 Time, A1 Velocity, A2 Time, A2 Velocity, HC Time, PD, DA, SP-A1, CBI, TBI and so on.

    Baseline in all groups and after 3m medication in VKC group

Secondary Outcomes (7)

  • Eye rubbing frequency

    Baseline in SAC and VKC group, and after 3m medication in VKC group

  • Ocular allergic symptom scores

    Baseline in SAC and VKC group, and after 3m medication in VKC group

  • Ocular sign scores

    Baseline in SAC and VKC group, and after 3m medication in VKC group

  • Morphological parameters of corneal topography

    Baseline in all groups and after 3m medication in VKC group

  • Corneal epithelial thickness

    Baseline in all groups and after 3m medication in VKC group

  • +2 more secondary outcomes

Study Arms (4)

nomal

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.

seasonal allergic conjunctivitis(SAC)

Eye rubbing frequency, ocular allergy symptom scores, physical sign scores, corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured, and comparative analysis of corneal biomechanics with other groups and correlation analysis of corneal biomechanical parameters and other measurement indicators will be performed.

vernal keratoconjunctivitis (VKC)

At first visit, eye rubbing frequency, ocular allergy symptom scores, physical sign scores, corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured. All patients will adopt a unified medication regimen: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 will be replaced with 0.02% flumirone eye drops twice daily, and rest of the medication will remain unchanged. The same ophthalmological examinations will be performed again after 3 month medication.

keratoconus

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

Eligibility Criteria

Age7 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The patients of Zhongshan ophthalmic center and healthy volunteers recruited.

You may qualify if:

  • No abnormalities are found by slit lamp and Pentacam.
  • Diopters: diopter of spherical: -6.0D\~+3.0D, diopter of cylinder: -2.0D\~+2.0D, spherical equivalent: -6.0D\~+3.0D
  • Best corrected visual acuity ≥ 1.0

You may not qualify if:

  • Patients diagnosed with other eye diseases other than refractive error.
  • With a history of eye surgery or trauma.
  • With systemic diseases such as immune diseases and connective tissue diseases.
  • With a family history of keratoconus and glaucoma.
  • Wear soft contact lens within 2 weeks or rigid contact lens within 1 month.
  • SAC group
  • Symptoms: Itching, foreign body sensation, increased discharge in conjunctival sac. And children may mainly show an increase in blinking frequency.
  • Signs: conjunctival hyperemia, swelling, tarsal papillae.
  • Medical history: seasonal onset
  • Diopters: diopter of spherical: -6.0D\~+3.0D, diopter of cylinder: -2.0D\~+2.0D, spherical equivalent: -6.0D\~+3.0D
  • Best corrected visual acuity ≥ 0.8
  • Corneal scar.
  • Other active inflammatory diseases of the eye.
  • With a history of eye surgery or trauma.
  • With systemic diseases such as immune diseases and connective tissue diseases.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, 510060, China

RECRUITING

Related Publications (2)

  • Wang Q, Yu F, Feng Z, Li W, Li N, Du X, Zhao X, Li S, Yuan J. Changes in Anterior and Posterior Corneal Elevation in Patients With Allergic Conjunctivitis. Front Med (Lausanne). 2021 Nov 24;8:788302. doi: 10.3389/fmed.2021.788302. eCollection 2021.

    PMID: 34901095DERIVED

  • Wang Q, Deng Y, Li S, Du X, Zhao X, Zhang T, Yuan J. Corneal biomechanical changes in allergic conjunctivitis. Eye Vis (Lond). 2021 May 3;8(1):17. doi: 10.1186/s40662-021-00241-7.

    PMID: 33934706DERIVED

MeSH Terms

Conditions

Conjunctivitis, AllergicKeratoconus

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesCorneal Diseases

Study Officials

  • Jin Yuan, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian wang, MD

CONTACT

86-018843014719419059130@qq.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 6, 2020

Study Start

November 10, 2019

Primary Completion

May 31, 2021

Study Completion

June 30, 2021

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)