A Study of a Novel Scheimpflug Device in Diagnosing Keratoconus

Active, not recruiting

• Conditions: Scansys; Pentacam; Corvis ST; Keratoconus; Subclinical Keratoconus
• Interventions: Other: Pentacam, Corvis ST and Scansys

• Registration Number: NCT06119321
• Lead Sponsor: Tianjin Eye Hospital

Brief Summary

Comparison of the screening and diagnosis ability of the novel Scheimpflug-based tomography device (Scansys) with Pentacam and the Scheimpflug-based biomechanics device (Corvis ST) for keratoconus.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-04
• Study First Submitted: 2023-10-25
• Primary Completion: 2023-11-01
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Study Completion: 2024-12-31

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

• The presence of ocular diseases other than myopia and keratoconus;
• Ocular trauma;
• Previous ocular surgery;
• 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;
• Pregnant and lactating women;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subclinical keratoconus	Pentacam, Corvis ST and Scansys	-
Keratoconus	Pentacam, Corvis ST and Scansys	-
Normal control group	Pentacam, Corvis ST and Scansys	-

Primary Outcome Measures

Name	Time	Method
screening and diagnosis ability	one year	Calculate the cut-off values, sensitivity and specificity of parameters measured by Pentacam, Corvis ST and Scansys in diagnosing keratoconus. Use Receiver operating characteristic curves (ROC) to analyze the optimal parameters to distinguish between the three groups.

Trial Locations

Locations (1)

Tiajin Eye Hospital; 🇨🇳 Tianjin, Tianjin, China