The Collagen Factors of Rapid Progression of Keratoconus in Children.

NCT06722937 | Recruiting DMC

• 1 other identifier: 2023KYPJ328
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus

Keywords

keratoconus; pediatric; Corneal biomechanics; collagen

Outcome Measures

Primary Outcomes (12)

• Thinnest corneal thickness

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

  1 year

• Kmax

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

  1 year

• ISV

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

  1 year

• IVA

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

  1 year

• IHA

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

  1 year

• IHD

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

  1 year

• CBI

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

  1 year

• TBI

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

  1 year

• SPA1

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

  1 year

• SSI

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

  1 year

• Corneal stromal cell density

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

  1 year

• Mutations in collagen related genes

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

  1 year

Secondary Outcomes (4)

• Frame best corrected visual acuity

  1 year

• Spherical power

  1 year

• Cylindrical power

  1 year

• Axial length

  1 year

Study Arms (4)

Keratoconus group of children

Other: Observation

Keratoconus group of adult

Other: Observation

Control group of children

Other: Observation

Control group of adult

Other: Observation

Interventions

Observation OTHER

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

Control group of adult; Control group of children; Keratoconus group of adult; Keratoconus group of children

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center,Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Related Links

• Registration information of this study in China

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood DNA sequencing analysis

MeSH Terms

Conditions

Keratoconus

Interventions

Observation

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Dan Li, MD

CONTACT

+86 188 1149 6522; canotoday@foxmail.com

Junwen Zeng, PhD

CONTACT

+86 136 0286 0456; zeng_zoc@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 9, 2024
• Study Start: April 14, 2023
• Primary Completion: April 13, 2025
• Study Completion: April 13, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD and supporting information will be permanently available (start date) on December 30, 2025.
• Access Criteria: Any non-commercial scholars and institutions can apply to access the IPD and supporting information.

Locations

CN (1)