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Not yet recruitingNCT07553832Updated Apr 28, 2026

Clinical and Subclinical Keratoconus Cohort Study

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
421
Ages
4 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Keratoconus

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03

In context

Keratoconus

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

subclinical keratoconus and keratoconus

Eligibility criteria

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 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.
Terms in these criteria, in plain language(1)

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.

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
421 participants (estimated)
Patient registry
No

Groups and cohorts

  • keratoconus

    keratoconus patient

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What researchers measure

Primary outcomes

  1. Kmax

    Corneal Topography Pentacam

    Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Secondary outcomes

  1. BCVA

    Visual Acuity Examination

    Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  2. 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

Other outcomes

  1. Corneal Endothelial Cell Count

    Corneal endothelial cell counting

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  2. Ocular Biometry Parameters

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  3. OCT Imaging Findings

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  4. Contrast Sensitivity

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  5. Ocular Surface Analysis

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07553832
Collaborators
Hainan Eye Hospital, The People's Hospital of Ningxia
Responsible party
Sponsor
First posted
Apr 28, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Apr 28, 2026

Study contacts

Xiao Yang
Contact
yangx_zoc@163.com
13760766303

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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