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A Study of a Novel Scheimpflug Device in Diagnosing Keratoconus

Evaluation of a Novel Scheimpflug Device for Detection of Early Keratoconus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06119321
Enrollment
200
Registered
2023-11-07
Start date
2023-05-04
Completion date
2024-12-31
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corvis ST, Keratoconus, Pentacam, Scansys, Subclinical Keratoconus

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.

Interventions

OTHERPentacam, Corvis ST and Scansys

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

Sponsors

Tianjin Eye Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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;

Design outcomes

Primary

MeasureTime frameDescription
screening and diagnosis abilityone yearCalculate 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026