Refractive ErrorsNCT03906279
Choroidal Thickness Change in Response to Physiological and Refractive Changes
An observational study of Refractive Errors and Accommodation Disorder, run by Wrocław University of Science and Technology at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Accommodation Disorder
- How many people
- 250 participants
- Where
- 1 sitePoland
- Study dates
- 10 Apr 2019to Feb 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with refractive error
Who may be able to join
- participants with refractive error
- willing and able to understand and sign an informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Refractive Errors, Accommodation Disorder
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myopic participants | Not described | |
| Emmetropic participants | Not described | |
| Hyperopic participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Submacular choroidal thickness
OCT EDI recorded scans will be proceed with the custom-made software to determine choroidal thickness in the submacular region.
Measured: 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.
Measured: 1 day
Secondary outcomes (9)
Axial length of the globe
Measured with optical biometer (Lenstar)
Measured: 1 day
Anterior chamber depth - optical biometry
Measured with optical biometer (Lenstar)
Measured: 1 day
Phakic lens thickness
Measured with optical biometer (Lenstar)
Measured: 1 day
White to white diameter
Measured with optical biometer (Lenstar)
Measured: 1 day
Angle to angle diameter of anterior chamber
Measured with optical coherent tomography for anterior chamber
Measured: 1 day
Anterior chamber depth - OCT
Measured with optical coherent tomography for anterior chamber
Measured: 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.
Measured: 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)
Measured: 1 day
Best-corrected visual acuity
examined on ETDRS charts different for right and left eye
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start10 Apr 2019
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Wrocław University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Sponsor
- Investigators
- Joanna Przeździecka-Dołyk, PhD, Principal investigator, Wrocław University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906279
- Sponsor's protocol ID
- ST002.2018
- Status last verified
- Mar 2022
- First submitted
- 3 Apr 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We intend to share anonymised data
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Measurements of Choroidal Thickness Change in Response to Physiological and Refractive Changes
- ClinicalTrials.gov ID
- NCT03906279
- Acronym / sponsor ID
- ST002.2018
- Conditions
- Refractive Errors, Accommodation Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Wrocław University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myopic participants | – | – |
| Emmetropic participants | – | – |
| Hyperopic participants | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractive error
Key inclusion criteria (2 listed)
- participants with refractive error
- willing and able to understand and sign an informed consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Submacular choroidal thickness
Time frame: 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
Time frame: 1 day
OCT EDI recorded scans will be proceed with the custom-made software to determine choroidal thickness in the peripapillar region.
9 secondary outcomes
Axial length of the globe
Time frame: 1 day
Anterior chamber depth - optical biometry
Time frame: 1 day
Phakic lens thickness
Time frame: 1 day
White to white diameter
Time frame: 1 day
Angle to angle diameter of anterior chamber
Time frame: 1 day
Anterior chamber depth - OCT
Time frame: 1 day
Corneal keratometry (steep meridian and its axis and flat meridian with its axis)
Time frame: 1 day
Spherical ametropia with cylindrical power of correcting lenses
Time frame: 1 day
Best-corrected visual acuity
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Undecided. We intend to share anonymised data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Przeździecka-Dołyk, PhD principal investigator
Wrocław University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors and Accommodation Disorder, run by Wrocław University of Science and Technology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Submacular choroidal thickness (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.