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

November 21, 2023 updated by: Tianjin Eye Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shuangcheng Li, Master
  • Phone Number: 022-27313336-7539
  • Email: lscdoc@163.com

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tiajin Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients premedicated for refractive surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
screening and diagnosis ability
Time Frame: 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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement consistency
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Eye Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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