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

Recruiting

• Conditions: Scansys, Pentacam, Keratoconus, Subclinical Keratoconus

• Registration Number: NCT06152484
• Lead Sponsor: Tianjin Eye Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-10-30
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-21
• Last Update Submitted: 2023-11-21
• Study First Posted: 2023-11-30
• Last Update Posted: 2023-11-30
• Primary Completion: 2024-02-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
screening and diagnosis ability	one year	Evaluate 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 Outcome Measures

Name	Time	Method
Measurement consistency	one year	The 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.

Trial Locations

Locations (1)

Tiajin Eye Hospital; 🇨🇳 Tianjin, Tianjin, China