NCT06109636

Brief Summary

Evaluation of the ciliary muscle thickness, area, and anterior chamber angle, as well as anterior sclera thickness in subjects, to investigate the relationship between these measurements and corneal biomechanics. Clarify whether aqueous humor displacement, anterior sclera, and ciliary muscles influence the assessment of in vivo corneal biomechanics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 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

March 4, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 21, 2023

Last Update Submit

October 28, 2023

Conditions

Ciliary Muscle ThicknessAnterior Sclera ThicknessCorneal BiomechanicsCASIA2

Outcome Measures

Primary Outcomes (2)

  • scleral and ciliary muscle thickness

    The thickness of scleral and ciliary muscle(Casia2, quantitative data through the utilization of its integrated ruler system)

    one year

  • biomechanical parameters

    The biomechanical parameters(Corvis ST, exporting the quality-assured csv files to analysis)

    one year

Study Arms (1)

Normal group

Other: Pentacam, Corvis ST and Casia2

Interventions

Pentacam, Corvis ST and Casia2OTHER

scleral and ciliary muscle thickness were obtained by Casia2, biomechanical parameters were obtained by Pentacam and Corvis ST

Normal group

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:

  • Corneal disease;
  • Ocular trauma;
  • Previous ocular surgery;
  • Any anterior segment diseases except cataract;
  • 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

Study Officials

  • Yan Wang, Prof

    Tianjin Eye Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 21, 2023

First Posted

October 31, 2023

Study Start

March 4, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

CN(1)