NCT06722937 The Collagen Factors of Rapid Progression of Keratoconus in Children.
| NCT ID | NCT06722937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhongshan Ophthalmic Center, Sun Yat-sen University |
| Condition | Keratoconus |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2023-04-14 |
| Primary Completion | 2025-04-13 |
Trial Parameters
Eligibility Fast-Check
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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.
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 sy