KeratoconusNCT07553832
Clinical and Subclinical Keratoconus Cohort Study
An observational study of Keratoconus, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Keratoconus
- How many people
- 421 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: subclinical keratoconus and keratoconus
Who may be able to join
- 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.
Who cannot join
- Patients with a history of ocular surgery and significant corneal scarring.
- Patients who could not understand or cooperate with the examination and follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Ophthalmic Center Sun Yat-Sen University
Guangzhou, Guangdong, 510060
Xiao Yang, 13760766303, yangx_zoc@163.com
About this 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.
- Conditions
- Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| keratoconus | keratoconus patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kmax
Corneal Topography Pentacam
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary outcomes (2)
BCVA
Visual Acuity Examination
Measured: 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
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 421 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hainan Eye Hospital, The People's Hospital of Ningxia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553832
- Sponsor's protocol ID
- 2025KYPJ038
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Subclinical Keratoconus Cohort Study
- ClinicalTrials.gov ID
- NCT07553832
- Acronym / sponsor ID
- 2025KYPJ038
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 421 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Hainan Eye Hospital, The People's Hospital of Ningxia
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| keratoconus | – | –keratoconus patient |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subclinical keratoconus and keratoconus
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (2 listed)
- Patients with a history of ocular surgery and significant corneal scarring.
- Patients who could not understand or cooperate with the examination and follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kmax
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Corneal Topography Pentacam
2 secondary outcomes
BCVA
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
BAD-D
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Keratoconus
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Yang (13760766303, yangx_zoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kmax (time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.