A Study of a Novel Scheimpflug Device in Diagnosing Keratoconus

October 31, 2024 updated by: Tianjin Eye Hospital

Evaluation of a Novel Scheimpflug Device for Detection of Early Keratoconus

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
screening and diagnosis ability
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Eye Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Actual)

November 1, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023026

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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