Prediction for Abnormal Topography Corneas Using New Biomechanical Parameter - Biomechanical Stable Index

Tianjin Eye Hospital1 site in 1 country315 target enrollmentJuly 16, 2018

ConditionsKeratoconus, Stable

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Keratoconus, Stable
Sponsor: Tianjin Eye Hospital
Enrollment: 315
Locations: 1
Primary Endpoint: stable
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis.

Registry

clinicaltrials.gov

Start Date

July 16, 2018

End Date

December 1, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Tianjin Eye Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;
•No clinical manifestation of keratoconus（Corneal stromal thinning, Cone-shaped anterior protrusions, Fleischers ring, Vogts striae, Epithelial or subepithelial scarring）

Exclusion Criteria

•corneal disease;
•ocular trauma; 3) 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;

Outcomes

Primary Outcomes

stable

Time Frame: one year

No alterations in morphological(Pentacam parameters, BAD\<0.42, TCT\<10μm) and biomechanical(Corvis ST, parametersCBI\<0.2, SPA1\<10) parameters between the first and last follow-up.