Choroidal Thickness Change in Response to Physiological and Refractive Changes

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03906279

Enrollment

250

Registered

2019-04-08

Start date

2019-04-10

Completion date

2026-02-28

Last updated

2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accommodation Disorder, Refractive Errors

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
Phakic lens thickness	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
Axial length of the globe	1 day	Measured with optical biometer (Lenstar)
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.
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)
Best-corrected visual acuity	1 day	examined on ETDRS charts different for right and left eye
Anterior chamber depth - OCT	1 day	Measured with optical coherent tomography for anterior chamber
Anterior chamber depth - optical biometry	1 day	Measured with optical biometer (Lenstar)

Countries

Poland

Outcome results