Zhongshan Ophthalmic Center Sun Yat-Sen University
Guangzhou, Guangdong, 510060, China
NCT Number: NCT07553832
The pathogenesis of keratoconus remains unclear, and its natural course has yet to be fully understood. For non-progressive patients and post-surgical cases, clinical management primarily involves follow-up observation, with significant challenges in visual rehabilitation. This study aims to establish a prospective keratoconus cohort to identify risk factors, natural progression, and the efficacy of interventions. Additionally, it seeks to explore changes in ocular biometric parameters and other pathophysiological characteristics in keratoconus patients, investigate the relationship between keratoconus and systemic diseases or comorbidities, and assess refractive interventions and visual rehabilitation strategies for keratoconus patients.
Trial opening soon.
Get Notified4 year and older
All sexes
Observational
Guangzhou, Guangdong, 510060, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1.1.4 1.6≤BAD-D < 2.6 in Pantacam. 1.2 Patients aged 4 years or older. 1.3 informed consent was obtained from patients. If the patient was younger than 18 years of age, the patient and guardian provided written informed consent.
2.1 The contralateral eye was diagnosed with keratoconus, and the included eye met the following criteria: 2.1.1 BCVA≥1.0 2.1.2 No obvious abnormal signs under slit lamp; 2.1.3 BAD-D < 2.6 in Pantacam. 2.2 Age ≥ 4 years old. 2.3 informed consent was obtained from patients. If the patient was younger than 18 years of age, the patient and guardian provided written informed consent.
3.1 History of myopia and astigmatism, BCVA≤1.0 3.2 Slit-lamp examination reveals at least one sign: corneal thinning, conical protrusion, Vogts striae, Fleischers rings, or anterior stromal scarring.
3.3 abnormal corneal topography features, such as asymmetric bow tie, subtemporal steeping, abnormal thickness distribution, and reduced minimum thickness, with BAD-D≥2.6 in Pantacam.
3.4 Age ≥ 4 years old. 3.5 Informed consent was obtained from patients. If the patient was younger than 18 years of age, the patient and guardian provided written informed consent.
Exclusion criteria
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Corneal Topography Pentacam
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Visual Acuity Examination
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Belin/Ambrósio Deviation Display from Corneal Topography Pentacam
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Corneal endothelial cell counting
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Contact information is provided by the study sponsor or research team.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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