Skip to content

The Collagen Factors of Rapid Progression of Keratoconus in Children.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06722937
Acronym
KCLD
Enrollment
160
Registered
2024-12-09
Start date
2023-04-14
Completion date
2025-04-13
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

keratoconus, pediatric, Corneal biomechanics, collagen

Brief summary

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.

Detailed description

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.

Interventions

OTHERObservation

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

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* ① Patients with keratoconus who visit the refractive clinic. 1. The height of the posterior corneal surface is greater than 16 microns under the Pentacam corneal topography. 2. ARTAve \< 424 microns, ARTMax \< 339 microns. 3. 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.

Design outcomes

Primary

MeasureTime frameDescription
Mutations in collagen related genes1 yearThe expressions and mutations in collagen related genes(COL4A3, COL4A4 COL5A1, COL6A2, TGFBI, LOX, MMP9, TIMP1) using the DNA Sequencing Technology.
TBI1 yearMeasurement of the tomographical biomechanical index of cornea using the Corneal Biomechanical Analyzer.
SPA11 yearMeasurement of the stiffness parameter at the first applanation of cornea using the Corneal Biomechanical Analyzer.
SSI1 yearMeasurement of the stress-strain index of cornea using the Corneal Biomechanical Analyzer.
Corneal stromal cell density1 yearMeasurement of the corneal stromal cell density using in vivo corneal confocal microscopy.
CBI1 yearMeasurement of the corvis biomechanical index of cornea using the Corneal Biomechanical Analyzer.
Thinnest corneal thickness1 yearMeasurement of the thinnest point corneal thickness using the Three-Dimensional Anterior Segment Analyzer.
Kmax1 yearMeasurement of the maximum keratometry from the anterior corneal surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
ISV1 yearMeasurement of the index of surface variance of corneal front surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
IVA1 yearMeasurement of the index of vertical asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
IHA1 yearMeasurement of the index of height asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
IHD1 yearMeasurement of the index of height decentration the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.

Secondary

MeasureTime frameDescription
Spherical power1 yearMeasurement of myopic refraction of eye using subjective refraction methods.
Cylindrical power1 yearMeasurement of astigmatism of eye using subjective refraction methods.
Axial length1 yearMeasurement of axial length of eye using IOL-Master 700.
Frame best corrected visual acuity1 yearMeasurement of best-corrected visual acuity of eye using visual charts.

Countries

China

Contacts

Primary ContactDan Li, MD
canotoday@foxmail.com+86 188 1149 6522
Backup ContactJunwen Zeng, PhD
zeng_zoc@163.com+86 136 0286 0456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026