Evaluation of Morphology Abnormal Cornea Stability With Corneal Biomechanical

Keratoconus, Stable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05748002
• Other study ID #: 2023002
• Status: Completed
• Start date: July 16, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2023
• Source: Tianjin Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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;

4. No clinical manifestation of keratoconus(Corneal stromal thinning, Cone-shaped anterior protrusions, Fleischers ring, Vogts striae, Epithelial or subepithelial scarring) Exclusion Criteria:1) corneal disease;

2) 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;

Related Conditions & MeSH terms

• Keratoconus
• Keratoconus, Stable

Intervention

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

Locations

Country	Name	City	State
China	Tiajin Eye Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stable	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.	one year