An observational study in Keratoconus, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational
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.
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 421 is above the median of 130 across 97 observational studies indexed under Keratoconus.
Browse Keratoconus studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
subclinical keratoconus and keratoconus
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 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.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
keratoconus patient
Kmax
Corneal Topography Pentacam
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
BCVA
Visual Acuity Examination
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
BAD-D
Belin/Ambrósio Deviation Display from Corneal Topography Pentacam
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Corneal Endothelial Cell Count
Corneal endothelial cell counting
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Ocular Biometry Parameters
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
OCT Imaging Findings
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Contrast Sensitivity
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Ocular Surface Analysis
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Zhongshan Ophthalmic Center, Sun Yat-sen University →