Choroidal Thickness Change in Response to Physiological a... | NCT03906279

Studies
Choroidal Thickness Change in Response to Physiological and Refractive Changes

NCT03906279

Sponsor

Wrocław University of Science and Technology

Status

Unknown status

Last Update Posted

Mar 29, 2022Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Refractive Errors
Accommodation Disorder

Interventions

Not provided

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2019Actual

Primary Completion Date

Feb 2024Estimated

Completion Date

Feb 2026Estimated

First Submitted Date

Apr 3, 2019

First Submission Date that Met QC Criteria

Apr 3, 2019

First Posted Date

Apr 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2022

Last Update Posted Date

Mar 29, 2022Actual

Name	Class
Wroclaw Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Axial length of the globe	Measured with optical biometer (Lenstar)	1 day
Anterior chamber depth - optical biometry	Measured with optical biometer (Lenstar)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with refractive error

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joanna Przeździecka-Dołyk, PhD	Wrocław University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Optics and Photonics		Wroclaw		50-370	Poland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

We intend to share anonymised data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Label	Type	Description	Intervention Names
Myopic participants
Emmetropic participants
Hyperopic participants