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New study aims to unlock mysteries of keratoconus progression

NCT ID NCT07553832

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 421 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

4 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Zhongshan Ophthalmic Center Sun Yat-Sen University

    Guangzhou, Guangdong, 510060, China

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