Choroidal Thickness Change in Response to Physiological and Refractive Changes

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03906279
• Other study ID #: ST002.2018
• Status: Active, not recruiting
• Start date: April 10, 2019
• Est. completion date: February 2026

Study information

• Verified date: March 2022
• Source: Wroclaw University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: February 2026
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accommodation Disorder
• Refractive Errors

Locations

Country	Name	City	State
Poland	Department of Optics and Photonics	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Wroclaw University of Science and Technology	Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Axial length of the globe	Measured with optical biometer (Lenstar)	1 day
Secondary	Anterior chamber depth - optical biometry	Measured with optical biometer (Lenstar)	1 day
Secondary	Phakic lens thickness	Measured with optical biometer (Lenstar)	1 day
Secondary	White to white diameter	Measured with optical biometer (Lenstar)	1 day
Secondary	Angle to angle diameter of anterior chamber	Measured with optical coherent tomography for anterior chamber	1 day
Secondary	Anterior chamber depth - OCT	Measured with optical coherent tomography for anterior chamber	1 day
Secondary	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
Secondary	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
Secondary	Best-corrected visual acuity	examined on ETDRS charts different for right and left eye	1 day