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Evolution of a Novel Optical Coherence Tomography Based Index in Diagnosing Keratoconus

A Study on Evaluating the Consistency of CASIA2, Pentacam, and Corvis ST Measurement Parameters and the Diagnostic Efficacy of Early Keratoconus

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06152484
Enrollment
200
Registered
2023-11-30
Start date
2023-07-01
Completion date
2024-04-01
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scansys, Pentacam, Keratoconus, Subclinical Keratoconus

Keywords

Scansys, Pentacam, Keratoconus, subclinical keratoconus

Brief summary

Comparison of corneal topography based on oct OCT principle (CASIA2) with Pentacam and Scheimpflug-based biomechanical devices (Corvis ST) in screening and diagnosing keratoconus; and evaluation of the consistency with Pentacam in measuring corneal parameters (such as curvature and thickness).

Interventions

morphological and biomechanical parameters of corneal were obtain by CASIA2, Pentacam and Corvis ST

Sponsors

Tianjin Eye Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. Best corrected visual acuity (BCVA) ≥ 20/20; 2. No other eye diseases except myopia and astigmatism; 3. The cornea was transparent, and there was no cloud or pannus;

Exclusion criteria

1. The presence of ocular diseases other than myopia and keratoconus; 2. Ocular trauma; 3. Previous ocular surgery; 4 Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; 6. Pregnant and lactating women;

Design outcomes

Primary

MeasureTime frameDescription
screening and diagnosis abilityone yearEvaluate the sensitivity and specificity of parameters measured by CASIA2, Pentacam in diagnosing keratoconus using Receiver operating characteristic curves (ROC), and compare the Ectasia Screening Similarity(ESS)and D-value diagnostic efficacy using Area under the ROC curve (AUROC). Use the Delong test to compare the accuracy of various parameters in diagnosing early keratoconus.

Secondary

MeasureTime frameDescription
Measurement consistencyone yearThe independent sample T-test is used to compare inter- group differences in baseline data. Use independent sample T-test and One-way ANOVA to evaluate the consistency of the measurement results (anterior and posterior corneal curvature, corneal refractive index, CCT) obtained by CASIA2 and Pentacam.Finally, the ultimate outcome(such ad:K1 K2 KMax CCT) indicates that the P-value between the two devices is less than 0.05 and ICC-value is more than 0.75.

Countries

China

Contacts

Primary ContactShuangcheng Li, Master
lscdoc@163.com022-27313336-7539

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026