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NCT Number: NCT06722937

The Collagen Factors of Rapid Progression of Keratoconus in Children.

The purpose of this observational study was to understand the differences in clinical features and mechanisms of keratoconus between children and adults. The main questions it aimed to answer as follows: (1) to understand the characteristics of keratoconus in Chinese children. (2) to observe corneal stromal cells at the cytological level using in vivo corneal laser confocal microscopy and explore the pathogenesis.

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Key information

Age range

10 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center,Sun Yat-Sen University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Dan Li, MD

SUB_INVESTIGATOR

Junwen Zeng, PhD

PRINCIPAL_INVESTIGATOR

Yanjie Yan

CONTACT

[email protected]

+86 20 6661 0729

About this study

Keratoconus is a progressive and asymmetric corneal dilation disease, in which the cornea presents as a conical protrusion, leading to irregular astigmatism, progressive myopia, corneal thinning, and subsequent visual impairment. If left untreated, acute corneal edema may occur in the late stage, resulting in a sharp decline in vision. This disease is a binocular disease and can occur unilaterally first. The incidence rate of the general population is 1/2000. Most of the diseases described in the literature began in adolescence, and about 90% of the patients were diagnosed at the age of 10. Some literature reported that the youngest patient was 4 years old, and the disease generally remained stable until about 40 years old.

Currently, research on pediatric keratoconus mainly includes the prevalence and morphological characteristics, as well as the progression of corneal collagen cross-linking surgery. The younger onset age of KC is often associated with rapid progression and late stage disease diagnosis. Scholars have observed that 88% of children develop KC after one year of diagnosis, and advocate for early corneal collagen cross-linking treatment for these children's eyes. However, the reasons for the onset and progression of keratoconus in children at a young age are not yet clear.

Due to the young age of onset and unclear reasons for the progression of pediatric keratoconus in clinical practice, as well as insufficient research on pediatric keratoconus in recent years, the clinical characteristics of pediatric keratoconus are still lacking, and the pathogenesis of pediatric keratoconus is still unclear. Therefore, this study aims to compare pediatric keratoconus with adult keratoconus, extract the characteristics of pediatric keratoconus, and use a live corneal laser confocal microscope to observe the stromal cellular structure inside pediatric keratoconus, in order to provide some clinical reference for the pathological understanding of pediatric keratoconus.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ① Patients with keratoconus who visit the refractive clinic.
  • The height of the posterior corneal surface is greater than 16 microns under the Pentacam corneal topography.
  • ARTAve < 424 microns, ARTMax < 339 microns.
  • Clinical non-inflammatory or traumatic corneal thinning and corneal astigmatism.
  • Aged between 10 and 50 years old, no gender restrictions.
  • Agree to accept and complete follow-up examinations on time. ④ I and my guardian understand and agree to participate in this clinical trial and sign the informed consent form.

Exclusion criteria

  • ① There is a history of contact lens wearing in the last four weeks.
  • poor fixation and can not cooperate with the examination. ③ History of eye trauma and surgery (including corneal collagen cross-linking surgery).
  • History of other related eye diseases: corneal disease, glaucoma, retinal choroid disease, etc..

⑤ severe eye diseases affecting imaging such as dry eye, conjunctivitis and pterygium.

⑥ Any systemic disease affecting eye morphology and refractive interstitium.

Treatment and study plan

observation

Other

Observe the clinical natural changes of eye parameters of the subjects.

Primary outcomes

  1. Thinnest corneal thickness

    Time frame: 1 year

    Measurement of the thinnest point corneal thickness using the Three-Dimensional Anterior Segment Analyzer.

  2. Kmax

    Time frame: 1 year

    Measurement of the maximum keratometry from the anterior corneal surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.

  3. ISV

    Time frame: 1 year

    Measurement of the index of surface variance of corneal front surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.

  4. IVA

    Time frame: 1 year

    Measurement of the index of vertical asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.

  5. IHA

    Time frame: 1 year

    Measurement of the index of height asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.

  6. IHD

    Time frame: 1 year

    Measurement of the index of height decentration the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.

  7. CBI

    Time frame: 1 year

    Measurement of the corvis biomechanical index of cornea using the Corneal Biomechanical Analyzer.

  8. TBI

    Time frame: 1 year

    Measurement of the tomographical biomechanical index of cornea using the Corneal Biomechanical Analyzer.

  9. SPA1

    Time frame: 1 year

    Measurement of the stiffness parameter at the first applanation of cornea using the Corneal Biomechanical Analyzer.

  10. SSI

    Time frame: 1 year

    Measurement of the stress-strain index of cornea using the Corneal Biomechanical Analyzer.

  11. Corneal stromal cell density

    Time frame: 1 year

    Measurement of the corneal stromal cell density using in vivo corneal confocal microscopy.

  12. Mutations in collagen related genes

    Time frame: 1 year

    The expressions and mutations in collagen related genes(COL4A3, COL4A4 COL5A1, COL6A2, TGFBI, LOX, MMP9, TIMP1) using the DNA Sequencing Technology.

Secondary outcomes

  1. Frame best corrected visual acuity

    Time frame: 1 year

    Measurement of best-corrected visual acuity of eye using visual charts.

  2. Spherical power

    Time frame: 1 year

    Measurement of myopic refraction of eye using subjective refraction methods.

  3. Cylindrical power

    Time frame: 1 year

    Measurement of astigmatism of eye using subjective refraction methods.

  4. Axial length

    Time frame: 1 year

    Measurement of axial length of eye using IOL-Master 700.

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Li, MD

CONTACT

[email protected]

+86 188 1149 6522

Junwen Zeng, PhD

CONTACT

[email protected]

+86 136 0286 0456

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

The Collagen Factors of Rapid Progression of Keratoconus in Children: an Observational Cohort Study of the Physiological Parameter

Acronym: KCLD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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