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NCT Number: NCT07553832

Clinical and Subclinical Keratoconus Cohort Study

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.

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Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

Location contact

Xiao Yang

CONTACT

[email protected]

13760766303

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Kmax

    Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

    Corneal Topography Pentacam

Secondary outcomes

  1. BCVA

    Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

    Visual Acuity Examination

  2. BAD-D

    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

Other outcomes

  1. Corneal Endothelial Cell Count

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

    Corneal endothelial cell counting

  2. Ocular Biometry Parameters

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  3. OCT Imaging Findings

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  4. Contrast Sensitivity

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  5. Ocular Surface Analysis

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Yang

CONTACT

[email protected]

13760766303

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Collaborators

  • Hainan Eye Hospital
  • The People's Hospital of Ningxia

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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