Clinical and Subclinical Keratoconus Cohort Study

Обзор

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.

Первичные конечные точки

• Kmax [Срок оценки: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]

Вторичные конечные точки (2)

• BCVA [Срок оценки: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
• BAD-D [Срок оценки: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]

Критерии участия

Критерии включения

• Inclusion criteria for suspected keratoconus 1.1 Both eyes did not meet the diagnostic criteria for keratoconus, and the included eyes met the criteria 1.1.1 BCVA≥1.0 1.1.2 No obvious abnormal signs under slit lamp; 1.1.3 At least one abnormal corneal topography feature: abnormal anterior corneal surface (KISA>60%); Asymmetric collar with or without meridional tilt (I-S >1.4D); Abnormal increase of corneal curvature (Km>47.2D); The posterior surface of the cornea was abnormally elevated (PTE>11μm).

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.

• Inclusion criteria for subclinical keratoconus:

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.

• Keratoconus inclusion criteria:

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.

Критерии исключения

• Patients with a history of ocular surgery and significant corneal scarring.
• Patients who could not understand or cooperate with the examination and follow-up.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhongshan Ophthalmic Center Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT07553832 · 2025KYPJ038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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