Clinical and Subclinical Keratoconus Cohort Study (NCT07553832) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical and Subclinical Keratoconus Cohort Study
China421 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range
4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
.1.4 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:
.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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Kmax
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Trial details
NCT IDNCT07553832
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
.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 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.
.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.