New study aims to unlock mysteries of keratoconus progression
NCT ID NCT07553832
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will follow 421 people with keratoconus, a condition that thins and bulges the cornea, to learn how it progresses and what factors increase risk. Researchers will use eye exams and imaging to track changes over time. The goal is to improve how doctors manage the disease and help patients see better.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 421 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
subclinical keratoconus and keratoconus
- Ages
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4 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: 1. 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. 2. 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. 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: 1. Patients with a history of ocular surgery and significant corneal scarring. 2. Patients who could not understand or cooperate with the examination and follow-up.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongshan Ophthalmic Center Sun Yat-Sen University
Guangzhou, Guangdong, 510060, China
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Other studies related to the condition(s) this trial covers.
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