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
1 other identifier
observational
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
November 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedNovember 30, 2023
November 1, 2023
7 months
October 30, 2023
November 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
screening and diagnosis ability
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 Outcomes (1)
Measurement consistency
one year
Study Arms (3)
Normal control group
Subclinical keratoconus
Keratoconus
Interventions
morphological and biomechanical parameters of corneal were obtain by CASIA2, Pentacam and Corvis ST
Eligibility Criteria
Patients premedicated for refractive surgery
You may qualify if:
- Best corrected visual acuity (BCVA) ≥ 20/20;
- No other eye diseases except myopia and astigmatism;
- The cornea was transparent, and there was no cloud or pannus;
You may not qualify if:
- The presence of ocular diseases other than myopia and keratoconus;
- Ocular trauma;
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tiajin Eye Hospital
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yan Wang, Prof
Tiajin Eye Hospita
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2023
First Posted
November 30, 2023
Study Start
July 1, 2023
Primary Completion
February 1, 2024
Study Completion
April 1, 2024
Last Updated
November 30, 2023
Record last verified: 2023-11