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

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06152484
Collaborator
(none)
200
1
9
22.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Pentacam, Corvis ST and CASIA2

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Study on Evaluating the Consistency of CASIA2, Pentacam, and Corvis ST Measurement Parameters and the Diagnostic Efficacy of Early Keratoconus
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Normal control group

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

Subclinical keratoconus

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

Keratoconus

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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;

  4. Pregnant and lactating women;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tiajin Eye Hospital Tianjin Tianjin China

Sponsors and Collaborators

  • Tianjin Eye Hospital

Investigators

  • Study Chair: Yan Wang, Prof, Tiajin Eye Hospita

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tianjin Eye Hospital
ClinicalTrials.gov Identifier:
NCT06152484
Other Study ID Numbers:
  • KY2023063
First Posted:
Nov 30, 2023
Last Update Posted:
Nov 30, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Tianjin Eye Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2023