## Protocol Section
### Identification Module
**NCT ID:** NCT03906279

**Brief Title:** Choroidal Thickness Change in Response to Physiological and Refractive Changes

**Official Title:** Automatic Measurements of Choroidal Thickness Change in Response to Physiological and Refractive Changes

#### Organization Study ID Info
**ID:** ST002.2018
#### Organization
**Class:** OTHER
**Full Name:** Wrocław University of Science and Technology
### Status Module
#### Completion Date
**Date:** 2026-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-03-29

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-27

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-04-10

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2019-04-08
**Type:** ACTUAL
**Study First Submit Date:** 2019-04-03
**Study First Submit QC Date:** 2019-04-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Wroclaw Medical University

#### Lead Sponsor

**Class:** OTHER

**Name:** Wrocław University of Science and Technology

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Refractive Errors

- Accommodation Disorder

### Design Module

#### Design Info

**Observational Model:** CASE_CROSSOVER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 250

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Months

### Arms Interventions Module

#### Arm Group 1

**Label:** Myopic participants

#### Arm Group 2

**Label:** Emmetropic participants

#### Arm Group 3

**Label:** Hyperopic participants

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Submacular choroidal thickness

**Time Frame:** 1 day

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

**Measure:** Peripapillar choroidal thickness

**Time Frame:** 1 day

#### Secondary Outcomes

**Description:** Measured with optical biometer (Lenstar)

**Measure:** Axial length of the globe

**Time Frame:** 1 day

**Description:** Measured with optical biometer (Lenstar)

**Measure:** Anterior chamber depth - optical biometry

**Time Frame:** 1 day

**Description:** Measured with optical biometer (Lenstar)

**Measure:** Phakic lens thickness

**Time Frame:** 1 day

**Description:** Measured with optical biometer (Lenstar)

**Measure:** White to white diameter

**Time Frame:** 1 day

**Description:** Measured with optical coherent tomography for anterior chamber

**Measure:** Angle to angle diameter of anterior chamber

**Time Frame:** 1 day

**Description:** Measured with optical coherent tomography for anterior chamber

**Measure:** Anterior chamber depth - OCT

**Time Frame:** 1 day

**Description:** Keratometry from autorefractokeratometer, topography or tomography recordings, radius measured in mm, magnitude of corneal astigmatism measured in local changes of dioptric power.

**Measure:** Corneal keratometry (steep meridian and its axis and flat meridian with its axis)

**Time Frame:** 1 day

**Description:** Subjective refraction made by trained optometrist. Spherical ametropia measured by dioptric power of spherical equivalent lens and magnitude of astigmatism measured in cylindrical dioptries of correcting lens with its axis. Mode of notation: sphero-cylinder with negative cylinder (e.g. +0.50DS -0.50DC 180ax)

**Measure:** Spherical ametropia with cylindrical power of correcting lenses

**Time Frame:** 1 day

**Description:** examined on ETDRS charts different for right and left eye

**Measure:** Best-corrected visual acuity

**Time Frame:** 1 day

### 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with refractive error

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Wrocław

**Country:** Poland

**Facility:** Department of Optics and Photonics

**Zip:** 50-370

#### Overall Officials

**Official 1:**

**Affiliation:** Wrocław University of Science and Technology

**Name:** Joanna Przeździecka-Dołyk, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** We intend to share anonymised data

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14872

- Name: Refractive Errors

- Relevance: HIGH

- As Found: Refractive Errors

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012030

- Term: Refractive Errors

### Misc Info Module

- Version Holder: 2024-05-24
