NCT03906279

Brief Summary

There is a great need for precise and repeatable measurements of the choroidal thickness. Including the diurnal physiological changes, accommodation and refractive error impact on those measurements.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

April 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

4.8 years

First QC Date

April 3, 2019

Last Update Submit

March 27, 2022

Conditions

Refractive ErrorsAccommodation Disorder

Outcome Measures

Primary Outcomes (2)

  • Submacular choroidal thickness

    OCT EDI recorded scans will be proceed with the custom-made software to determine choroidal thickness in the submacular region.

    1 day

  • Peripapillar choroidal thickness

    OCT EDI recorded scans will be proceed with the custom-made software to determine choroidal thickness in the peripapillar region.

    1 day

Secondary Outcomes (9)

  • Axial length of the globe

    1 day

  • Anterior chamber depth - optical biometry

    1 day

  • Phakic lens thickness

    1 day

  • White to white diameter

    1 day

  • Angle to angle diameter of anterior chamber

    1 day

  • +4 more secondary outcomes

Study Arms (3)

Myopic participants

Emmetropic participants

Hyperopic participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with refractive error

You may qualify if:

  • participants with refractive error
  • willing and able to understand and sign an informed consent form

You may not qualify if:

  • patient unable to participate in the study
  • any disease that causes visual opacity of optic media that unable to perform OCT scanning
  • current enrolment in another clinical trial/research project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Optics and Photonics

Wroclaw, 50-370, Poland

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Joanna Przeździecka-Dołyk, PhD

    Wrocław University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 8, 2019

Study Start

April 10, 2019

Primary Completion

February 1, 2024

Study Completion

February 1, 2026

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

PL(1)