Understanding keratoconus in children
The Collagen Factors of Rapid Progression of Keratoconus in Children: an Observational Cohort Study of the Physiological Parameter
Zhongshan Ophthalmic Center, Sun Yat-sen University · NCT06722937
This study looks at the signs and causes of keratoconus in children to see how it differs from adults and to better understand this eye condition that can affect vision.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 10 Years to 50 Years |
| Sex | All |
| Sponsor | Zhongshan Ophthalmic Center, Sun Yat-sen University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06722937 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the clinical features and mechanisms of keratoconus in children compared to adults. It focuses on understanding the characteristics of keratoconus in Chinese children and utilizes in vivo corneal laser confocal microscopy to observe corneal stromal cells at the cytological level. The study seeks to clarify the pathogenesis of this progressive corneal disease, which can lead to significant visual impairment if untreated.
Who should consider this trial
Good fit: Ideal candidates for this study are children and young adults aged 10 to 50 years diagnosed with keratoconus who can comply with follow-up examinations.
Not a fit: Patients with a history of contact lens wear in the last four weeks or those with other significant eye diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of keratoconus in pediatric patients, potentially enhancing treatment outcomes.
How similar studies have performed: While there is ongoing research on keratoconus, this specific focus on pediatric patients and their unique progression patterns is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Zhongshan Ophthalmic Center,Sun Yat-Sen University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Dan Li, MD
- Email: canotoday@foxmail.com
- Phone: +86 188 1149 6522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Keratoconus, keratoconus, pediatric, Corneal biomechanics, collagen