NCT06119321

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

October 25, 2023

Last Update Submit

October 31, 2024

Conditions

ScansysPentacamCorvis STKeratoconusSubclinical Keratoconus

Outcome Measures

Primary Outcomes (1)

  • screening and diagnosis ability

    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

Study Arms (3)

Normal control group

Other: Pentacam, Corvis ST and Scansys

Subclinical keratoconus

Other: Pentacam, Corvis ST and Scansys

Keratoconus

Other: Pentacam, Corvis ST and Scansys

Interventions

Pentacam, Corvis ST and ScansysOTHER

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

KeratoconusNormal control groupSubclinical keratoconus

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients premedicated for refractive surgery

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tiajin Eye Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Yan Wang, Prof

    Tianjin Eye Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

November 7, 2023

Study Start

May 4, 2023

Primary Completion

November 1, 2023

Study Completion

December 31, 2024

Last Updated

November 4, 2024

Record last verified: 2024-10

Locations

CN(1)