Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase
Observational
Started
2023-04-14
Last updated
2024-12-09
Condition(s) studied
Keratoconus
Investigational drug(s) / intervention(s)
Observation
Observation: Observe the clinical natural changes of eye parameters of the subjects.
Study 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.
Eligibility
Sex
ALL
Min age
10 Years
Max age
50 Years
Healthy volunteers
Accepted
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 outcome measure(s)
Thinnest corneal thickness — 1 year Measurement of the thinnest point corneal thickness using the Three-Dimensional Anterior Segment Analyzer.
Kmax — 1 year Measurement of the maximum keratometry from the anterior corneal surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
ISV — 1 year Measurement of the index of surface variance of corneal front surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
IVA — 1 year Measurement of the index of vertical asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
IHA — 1 year Measurement of the index of height asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
IHD — 1 year Measurement of the index of height decentration the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
CBI — 1 year Measurement of the corvis biomechanical index of cornea using the Corneal Biomechanical Analyzer.
TBI — 1 year Measurement of the tomographical biomechanical index of cornea using the Corneal Biomechanical Analyzer.
SPA1 — 1 year Measurement of the stiffness parameter at the first applanation of cornea using the Corneal Biomechanical Analyzer.
SSI — 1 year Measurement of the stress-strain index of cornea using the Corneal Biomechanical Analyzer.
Corneal stromal cell density — 1 year Measurement of the corneal stromal cell density using in vivo corneal confocal microscopy.
Mutations in collagen related genes — 1 year The expressions and mutations in collagen related genes(COL4A3, COL4A4 COL5A1, COL6A2, TGFBI, LOX, MMP9, TIMP1) using the DNA Sequencing Technology.
Trial sites (1)
Facility
City
Region
Status
Zhongshan Ophthalmic Center,Sun Yat-Sen University
Guangzhou
Guangdong
Recruiting
More Zhongshan Ophthalmic Center, Sun Yat-sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.