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A Study of a Novel Scheimpflug Device in Diagnosing Keratoconus

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06119321
Collaborator
(none)
200
Enrollment
1
Location
7.9
Anticipated Duration (Months)
25.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of the screening and diagnosis ability of the novel Scheimpflug-based tomography device (Scansys) with Pentacam and the Scheimpflug-based biomechanics device (Corvis ST) for keratoconus.

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

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of a Novel Scheimpflug Device for Detection of Early Keratoconus
Actual Study Start Date :
May 4, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Normal control group

Other: Pentacam, Corvis ST and Scansys
morphological and biomechanical parameters of corneal were obtain by Scansys, Pentacam and Corvis ST
Subclinical keratoconus

Other: Pentacam, Corvis ST and Scansys
morphological and biomechanical parameters of corneal were obtain by Scansys, Pentacam and Corvis ST
Keratoconus

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

Outcome Measures

Primary Outcome Measures

  1. screening and diagnosis ability [one year]

    Calculate the cut-off values, sensitivity and specificity of parameters measured by Pentacam, Corvis ST and Scansys in diagnosing keratoconus. Use Receiver operating characteristic curves (ROC) to analyze the optimal parameters to distinguish between the three groups.

Eligibility Criteria

Criteria

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

Exclusion Criteria:

  • The presence of ocular diseases other than myopia and keratoconus;

  • Ocular trauma;

  • Previous ocular surgery;

  • 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;

  • 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:
NCT06119321
Other Study ID Numbers:
  • KY2023026
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Oct 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 Nov 7, 2023