Clinical and Subclinical Keratoconus Cohort Study
ConditionKeratoconus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4+
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 population
subclinical keratoconus and keratoconus
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
421 Participants
are grouped into 1 trial groupGroup A: keratoconus
Trial outcomes
Primary outcomes
1
Kmax
Corneal Topography Pentacam
Time frame
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 yearsSecondary outcomes
1
BCVA
Visual Acuity Examination
Time frame
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years2
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 yearsOther outcomes
1
Corneal Endothelial Cell Count
Corneal endothelial cell counting
Time frame
Baseline, 1 year, 2 years, 3 years, 4 years, 5 years2
Ocular Biometry Parameters
Time frame
Baseline, 1 year, 2 years, 3 years, 4 years, 5 years3
OCT Imaging Findings
Time frame
Baseline, 1 year, 2 years, 3 years, 4 years, 5 years4
Contrast Sensitivity
Time frame
Baseline, 1 year, 2 years, 3 years, 4 years, 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead sponsor
Hainan Eye Hospital
Collaborator
The People's Hospital of Ningxia
Collaborator
Source ClinicalTrials.gov
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