MyopiaNCT05132140
Peripheral Choroidal Layer Response
A study testing adaptive optics system in people with Myopia, run by University of Houston.
Trial summary
The study aims to examine how the vascular layer of the eyeball (choroidal layer) responds when part of the visual field is exposed to specially generated visual stimulus. The study goal will be accomplished by producing specific blur visual stimulus at a particular visual field position and measure any consistent… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- adaptive optics system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to May 2023
- Phase
- Interventional
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Is between the ages of 18 and 40 yrs old
- Has normal best corrected visual acuity being 20/20 or better
- Has spherical refractive error between +1.00D and -6.00D.
- Is capable of fixating on the target.
- Has no prior ocular surgery.
- Has no ocular pathology except keratoconus.
- Can tolerate dilating eye drops
Who cannot join
- A person will be excluded from the study if he/she:
- Does not fall within above mentioned age group.
- Has chronic or systemic eye disease that would interfere with pupil dilation via eye drops.
- Underwent ocular surgeries or history of ocular trauma
- Has shallow anterior chamber angle and/or glaucoma.
- Has clinically significant dry eye.
Show all 15Show fewer
- Has signs of any choroidal or retinal pathology, and abnormalities in the visual pathway
- Has spherical refractive error that exceeds the limits outlined above.
- Has binocular anomalies (e.g. convergence insufficiency, strabismus, pseudo-myopia, amblyopia).
- Is an adult unable to consent
- Is an individual who is not yet adult (infants, children, teenagers)
- Is a pregnant woman
- Is a prisoner
- Is a student for whom you have direct access to/influence on grades
- Is an economically and/or educationally disadvantaged person
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Peripheral Choroidal Response to Pure Defocus and Oriented Blur Conditions
The study aims to examine how the vascular layer of the eyeball (choroidal layer) responds when part of the visual field is exposed to specially generated visual stimulus. The study goal will be accomplished by producing specific blur visual stimulus at a particular visual field position and measure any consistent thickness change pattern in the choroidal layer.
We propose to test the hypothesis that regional changes in the choroidal thickness may be induced differently after short-term exposure to specific visual stimuli.
- Conditions
- Myopia
- Being tested
- adaptive optics system
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adaptive optics systemDevice
the system consists of a wavefront sensor and a deformable mirror that measure and correct (or modify) the eye's optical imperfections (aberrations).
| Study group | Role | What they receive |
|---|---|---|
| normal healthy group | Experimental | Adaptive optics system: this system controls the optical quality of the eye at the peripheral visual field temporarily. Receives: Device: adaptive optics system |
What is being measured
The primary outcome is the main question the study is designed to answer.
choroidal thickness
A commercially available optical coherence tomography system will be used to measure changes in choroidal layer thickness before and after manipulating the peripheral optics.
Measured: up to 60 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geunyoung Yoon, University of Houston
- Investigators
- Geunyoung Yoon, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132140
- Sponsor's protocol ID
- STUDY00003210
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Choroidal Response to Pure Defocus and Oriented Blur Conditions
- ClinicalTrials.gov ID
- NCT05132140
- Acronym / sponsor ID
- STUDY00003210
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 24 Nov 2021 (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.
The study aims to examine how the vascular layer of the eyeball (choroidal layer) responds when part of the visual field is exposed to specially generated visual stimulus. The study goal will be accomplished by producing specific blur visual stimulus at a particular visual field position and measure any consistent thickness change pattern in the choroidal layer.
We propose to test the hypothesis that regional changes in the choroidal thickness may be induced differently after short-term exposure to specific visual stimuli.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal healthy group | Experimental | Device: adaptive optics systemAdaptive optics system: this system controls the optical quality of the eye at the peripheral visual field temporarily. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Is between the ages of 18 and 40 yrs old
- Has normal best corrected visual acuity being 20/20 or better
- Has spherical refractive error between +1.00D and -6.00D.
- Is capable of fixating on the target.
- Has no prior ocular surgery.
Key exclusion criteria (15 listed)
- Does not fall within above mentioned age group.
- Has chronic or systemic eye disease that would interfere with pupil dilation via eye drops.
- Underwent ocular surgeries or history of ocular trauma
- Has shallow anterior chamber angle and/or glaucoma.
- Has clinically significant dry eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adaptive optics systemthe system consists of a wavefront sensor and a deformable mirror that measure and correct (or modify) the eye's optical imperfections (aberrations). | Device | normal healthy group |
Primary outcome
choroidal thickness
Time frame: up to 60 mins
A commercially available optical coherence tomography system will be used to measure changes in choroidal layer thickness before and after manipulating the peripheral optics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
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.
Geunyoung Yoon, PhD principal investigator
University of Houston
Questions about this trial
What is this clinical trial studying?
A study testing adaptive optics system in people with Myopia, run by University of Houston.
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 8 inclusion and 15 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 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Geunyoung Yoon, PhD (7137437860, gyoon2@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
choroidal thickness (time frame: up to 60 mins). 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 30 Nov 2021.