Clinical trial NCT06722937: The Collagen Factors of Rapid Progression of Keratoconus in Children.
Official title: The Collagen Factors of Rapid Progression of Keratoconus in Children: an Observational Cohort Study of the Physiological Parameter
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Keratoconus
Keywords: keratoconus
pediatric
Corneal biomechanics
collagen
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 160
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consistently enrolled subjects aged between 10 and 50 years old with keratoconus and myopic astigmatism who visited the refractive clinic from April 2023 to April 2024

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Thinnest corneal thickness
timeFrame: 1 year
measure: Kmax
timeFrame: 1 year
measure: ISV
timeFrame: 1 year
measure: IVA
timeFrame: 1 year
measure: IHA
timeFrame: 1 year
measure: IHD
timeFrame: 1 year
measure: CBI
timeFrame: 1 year
measure: TBI
timeFrame: 1 year
measure: SPA1
timeFrame: 1 year
measure: SSI
timeFrame: 1 year
measure: Corneal stromal cell density
timeFrame: 1 year
measure: Mutations in collagen related genes
timeFrame: 1 year
Secondary outcomes:
measure: Frame best corrected visual acuity
timeFrame: 1 year
measure: Spherical power
timeFrame: 1 year
measure: Cylindrical power
timeFrame: 1 year
measure: Axial length
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center,Sun Yat-Sen University
state: Guangdong
Study officials:
References: