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NCT Number: NCT06119321

A Study of a Novel Scheimpflug Device in Diagnosing 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Scansys Corneal Diseases Corvis ST Eye Diseases Keratoconus Pentacam Subclinical Keratoconus

Sex eligibility

All sexes

Study type

Observational

Primary location

Tiajin Eye Hospital

Tianjin, Tianjin Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Pentacam, Corvis ST and Scansys

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tianjin Eye Hospital

Other

Registry information

Official study title

Evaluation of a Novel Scheimpflug Device for Detection of Early Keratoconus

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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