Clinical and Subclinical Keratoconus Cohort Study

NCT07553832 | Not Yet Recruiting

• 1 other identifier: 2025KYPJ038
• Study Type: observational
• Target: 421
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• Kmax

  Corneal Topography Pentacam

  Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Secondary Outcomes (2)

• BCVA

  Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

• BAD-D

  Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Other Outcomes (5)

• Corneal Endothelial Cell Count

  Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

• Ocular Biometry Parameters

  Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

• OCT Imaging Findings

  Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

Study Arms (1)

keratoconus

keratoconus patient

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subclinical keratoconus and keratoconus

You may qualify if:

• ≤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.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• Patients with a history of ocular surgery and significant corneal scarring.
• Patients who could not understand or cooperate with the examination and follow-up.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead
• Hainan Eye Hospital: collaborator
• The People's Hospital of Ningxia: collaborator

Study Sites (1)

Zhongshan Ophthalmic Center Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Central Study Contacts

Xiao Yang

CONTACT

13760766303; yangx_zoc@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)