Choroidal Thickness Change in Response to Physiological and Refractive Changes

Automatic Measurements of Choroidal Thickness Change in Response to Physiological and Refractive Changes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Refractive Errors; Accommodation Disorder

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Poland
  • Wrocław, Poland, 50-370
    • Department of Optics and Photonics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with refractive error

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Myopic participants
Emmetropic participants
Hyperopic participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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)	1 day
Phakic lens thickness	Measured with optical biometer (Lenstar)	1 day
White to white diameter	Measured with optical biometer (Lenstar)	1 day
Angle to angle diameter of anterior chamber	Measured with optical coherent tomography for anterior chamber	1 day
Anterior chamber depth - OCT	Measured with optical coherent tomography for anterior chamber	1 day
Corneal keratometry (steep meridian and its axis and flat meridian with its axis)	Keratometry from autorefractokeratometer, topography or tomography recordings, radius measured in mm, magnitude of corneal astigmatism measured in local changes of dioptric power.	1 day
Spherical ametropia with cylindrical power of correcting lenses	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)	1 day
Best-corrected visual acuity	examined on ETDRS charts different for right and left eye	1 day

Collaborators and Investigators

• Sponsor: Wrocław University of Science and Technology
• Collaborators: Wroclaw Medical University
• Investigators: Principal Investigator: Joanna Przeździecka-Dołyk, PhD, Wrocław University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2026

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: ST002.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We intend to share anonymised data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No