An observational study in Scansys, Pentacam, Keratoconus, Subclinical Keratoconus, sponsored by Tianjin Eye Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Tianjin Eye Hospital · Observational
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).
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 200 is above the median of 130 across 97 observational studies indexed under Keratoconus.
Browse Keratoconus studies →Tianjin Eye Hospital is the lead sponsor of 53 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients premedicated for refractive surgery
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Exclusion Criteria:
Other: Pentacam, Corvis ST and CASIA2
Other: Pentacam, Corvis ST and CASIA2
Other: Pentacam, Corvis ST and CASIA2
morphological and biomechanical parameters of corneal were obtain by CASIA2, Pentacam and Corvis ST
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.
Time frame: one year
Measurement consistency
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.
Time frame: one year
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Feb 2024, 7 months after the start.
Of 33 non-industry observational studies under Keratoconus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 204. This study's planned 7 months is below that.
Counting every sponsor, half of 36 studies reached it within 30 months; a quarter within 13 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
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Tianjin Eye Hospital