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Evaluation of Morphology Abnormal Cornea Stability With Corneal Biomechanical

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05748002
Collaborator
(none)
315
Enrollment
1
Location
52.5
Actual Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pentacam and Corvis ST

Study Design

Study Type:
Observational
Actual Enrollment :
315 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Prediction for Abnormal Topography Corneas Using New Biomechanical Parameter - Biomechanical Stable Index
Actual Study Start Date :
Jul 16, 2018
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
normal group

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

Outcome Measures

Primary Outcome Measures

  1. stable [one year]

    No alterations in morphological and biomechanical parameters between the first and last follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

  1. 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tiajin Eye Hospital Tianjin Tianjin China

Sponsors and Collaborators

  • Tianjin Eye Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tianjin Eye Hospital
ClinicalTrials.gov Identifier:
NCT05748002
Other Study ID Numbers:
  • 2023002
First Posted:
Feb 28, 2023
Last Update Posted:
Feb 28, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Keratoconus

Study Results

No Results Posted as of Feb 28, 2023