NCT05748002

Brief Summary

To evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 16, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

4.4 years

First QC Date

February 17, 2023

Last Update Submit

October 18, 2023

Conditions

Keratoconus, Stable

Outcome Measures

Primary Outcomes (1)

  • stable

    No alterations in morphological(Pentacam parameters, BAD\<0.42, TCT\<10μm) and biomechanical(Corvis ST, parametersCBI\<0.2, SPA1\<10) parameters between the first and last follow-up.

    one year

Study Arms (4)

stable group

Other: Pentacam and Corvis ST

subclinical keratoconus

Other: Pentacam and Corvis ST

normal group

Other: Pentacam and Corvis ST

follow up group

Other: Pentacam and Corvis ST

Interventions

Pentacam and Corvis STOTHER

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

follow up groupnormal groupstable 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:

  • \) ocular trauma; 3) 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; 4) 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
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 28, 2023

Study Start

July 16, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

CN(1)