Choroidal Thickness Change in Response to Physiological and Refractive Changes

Active, not recruiting

• Conditions: Accommodation Disorder; Refractive Errors

• Registration Number: NCT03906279
• Lead Sponsor: Wrocław University of Science and Technology

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 available

Study Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-08
• Study Start: 2019-04-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-27
• Last Update Posted: 2022-03-29
• Primary Completion: 2024-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripapillar choroidal thickness	1 day	OCT EDI recorded scans will be proceed with the custom-made software to determine choroidal thickness in the peripapillar region.
Submacular choroidal thickness	1 day	OCT EDI recorded scans will be proceed with the custom-made software to determine choroidal thickness in the submacular region.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Optics and Photonics; 🇵🇱 Wrocław, Poland