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
NCT Number: NCT06722937
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.
Interested in participating?
Request Info10 year–50 year
All sexes
Observational
Guangzhou, Guangdong, China
Location status: Recruiting
Dan Li, MD
SUB_INVESTIGATOR
Junwen Zeng, PhD
PRINCIPAL_INVESTIGATOR
Yanjie Yan
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
⑤ severe eye diseases affecting imaging such as dry eye, conjunctivitis and pterygium.
⑥ Any systemic disease affecting eye morphology and refractive interstitium.
Observe the clinical natural changes of eye parameters of the subjects.
Time frame: 1 year
Measurement of the thinnest point corneal thickness using the Three-Dimensional Anterior Segment Analyzer.
Time frame: 1 year
Measurement of the maximum keratometry from the anterior corneal surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
Time frame: 1 year
Measurement of the index of surface variance of corneal front surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
Time frame: 1 year
Measurement of the index of vertical asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
Time frame: 1 year
Measurement of the index of height asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
Time frame: 1 year
Measurement of the index of height decentration the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
Time frame: 1 year
Measurement of the corvis biomechanical index of cornea using the Corneal Biomechanical Analyzer.
Time frame: 1 year
Measurement of the tomographical biomechanical index of cornea using the Corneal Biomechanical Analyzer.
Time frame: 1 year
Measurement of the stiffness parameter at the first applanation of cornea using the Corneal Biomechanical Analyzer.
Time frame: 1 year
Measurement of the stress-strain index of cornea using the Corneal Biomechanical Analyzer.
Time frame: 1 year
Measurement of the corneal stromal cell density using in vivo corneal confocal microscopy.
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.
Time frame: 1 year
Measurement of best-corrected visual acuity of eye using visual charts.
Time frame: 1 year
Measurement of myopic refraction of eye using subjective refraction methods.
Time frame: 1 year
Measurement of astigmatism of eye using subjective refraction methods.
Time frame: 1 year
Measurement of axial length of eye using IOL-Master 700.
Contact information is provided by the study sponsor or research team.
Dan Li, MD
CONTACT
Junwen Zeng, PhD
CONTACT
Zhongshan Ophthalmic Center, Sun Yat-sen University
Other
The Collagen Factors of Rapid Progression of Keratoconus in Children: an Observational Cohort Study of the Physiological Parameter
Acronym: KCLD
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.
Published trials that share one or more normalized conditions with this study.
NCT07629557
Corneal Diseases, Eye Diseases
Westerville, Ohio, United States
View Trial DetailsNCT03030755
Cornea; Ectasia, Corneal Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT03923101
Corneal Diseases, Eye Diseases
Homburg, Saarland, Germany
View Trial DetailsNCT02138669
Corneal Diseases, Eye Diseases
Dallas, Texas, United States
View Trial Details