Evaluation of Morphology Abnormal Cornea Stability With Corneal Biomechanical

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

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.

Study Overview

• Status: Completed
• Conditions: Keratoconus, Stable
• Intervention / Treatment: Other: Pentacam and Corvis ST

• Study Type: Observational
• Enrollment (Actual): 315

Contacts and Locations

Study Locations

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

Participation Criteria

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;
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;

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal group	Other: Pentacam and Corvis ST; morphological and biomechanical parameters of corneal were obtain by Pentacam and Corvis ST
stable group	Other: Pentacam and Corvis ST; morphological and biomechanical parameters of corneal were obtain by Pentacam and Corvis ST
subclinical keratoconus	Other: Pentacam and Corvis ST; morphological and biomechanical parameters of corneal were obtain by Pentacam and Corvis ST
follow up group	Other: Pentacam and Corvis ST; morphological and biomechanical parameters of corneal were obtain by Pentacam and Corvis ST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital
• Investigators: Study Chair: Yan Wang, Prof, Tianjin Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: 2023002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No