Induced Defocus to the RetinaNCT03954886
Defocus Induced Changes on Choroidal Thickness
A study testing Plus powered optical lens in people with Induced Defocus to the Retina, run by University of Houston at 1 site in United States.
Trial summary
The goals of this study are to assess the short-term (10-60 minutes) effects of different magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid in children and adults, as well as to assess the recovery period. Read more about this study
- Who is it for?
- Ages 6 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Induced Defocus to the Retina
- What is being tested?
- Plus powered optical lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 31 Dec 2021
- 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 6 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 6 to 45 years of age (preliminary studies indicate that children under 6 cannot sit for imaging, and subjects over 45 do not respond to the optical defocus with expected choroidal thickness changes)
- Best corrected visual acuity of 20/25 or better in better-seeing eye
Who cannot join
- Age younger than 6 years or older than 45
- Best corrected visual acuity worse than 20/25 in better-seeing eye
- Ocular pathology or prior ocular injury
- Heavily-pigmented choroid that precludes accurate measurement of choroidal thickness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Houston College of Optometry
Houston, Texas, 77004
About this study
Official title: Effects of Defocus on Choroidal Thickness
The goals of this study are to assess the short-term (10-60 minutes) effects of different magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid in children and adults, as well as to assess the recovery period. Choroidal thickness will be measured non-invasively following 10-60 minutes of monocular exposure to -5 diopters to +5 diopters of optical defocus induced by spectacle lenses. The hypothesis is that choroidal thickness will increase with increasing myopic defocus and decrease with increasing hyperopic defocus. The relationship between the magnitude of defocus and the magnitude and direction of choroidal thickness change will be assessed.
Read the detailed description
The purpose of this study is to determine modifying factors inducing or protecting against the development or progression of myopia, or nearsightedness. Myopia has reached epidemic levels in urbanized countries, reaching up to 90% of the teenage and young adult population in urban Asia. Myopia represents a significant socioeconomic burden and poses a risk for associated ocular diseases such as retinal detachment, choroidal neovascularization, and glaucoma. The economic and public health burden of myopia are growing disproportionately to the population, spurring interest in the development of therapies to prevent occurrence or progression. Myopia generally occurs because the eye grows too long, with onset and progression occurring from about ages 6 to 20. Though much is known about factors that influence eye growth, the exact mechanisms by which they do so have not been elucidated.
The goals of this study are to assess the short-term (10-50 minutes) effects of different magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid in children and adults, as well as to assess the recovery period. Choroidal thickness will be measured non-invasively following 10-50 minutes of monocular exposure to -5D to +5D of optical defocus induced by spectacle lenses. The hypothesis is that choroidal thickness will increase with increasing myopic defocus and decrease with increasing hyperopic defocus. The relationship between the magnitude of defocus and the magnitude and direction of choroidal thickness change will be assessed.
- Conditions
- Induced Defocus to the Retina
- Being tested
- Plus powered optical lens
- Keywords
- Myopia, Choroid, Retina, Blur, Defocus, Eye growth
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plus powered optical lensDevice
A plus powered optical lens will be placed in front of one eye.
| Study group | Role | What they receive |
|---|---|---|
| Induced myopic defocus | Experimental | Subjects will view a television through a lens that induces blur to the retina for one hour. Images of the eye will be captured every 10 minutes Receives: Device: Plus powered optical lens |
| No defocus | No intervention | Subjects will view a television through a lens that induces no blur to the retina for one hour. Images of the eye will be captured every 10 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Changes in choroidal thickness following induced myopic defocus
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start15 May 2018
- Primary completion1 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced Defocus to the RetinaStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Ostrin, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954886
- Sponsor's protocol ID
- STUDY00000852
- Status last verified
- Mar 2022
- First submitted
- 15 May 2019
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD will be provided by request once published
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Defocus on Choroidal Thickness
- ClinicalTrials.gov ID
- NCT03954886
- Acronym / sponsor ID
- STUDY00000852
- Conditions
- Induced Defocus to the Retina
- Keywords
- Myopia, Choroid, Retina, Blur, Defocus, Eye growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 May 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.
The goals of this study are to assess the short-term (10-60 minutes) effects of different magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid in children and adults, as well as to assess the recovery period. Choroidal thickness will be measured non-invasively following 10-60 minutes of monocular exposure to -5 diopters to +5 diopters of optical defocus induced by spectacle lenses. The hypothesis is that choroidal thickness will increase with increasing myopic defocus and decrease with increasing hyperopic defocus. The relationship between the magnitude of defocus and the magnitude and direction of choroidal thickness change will be assessed.
Detailed description
The purpose of this study is to determine modifying factors inducing or protecting against the development or progression of myopia, or nearsightedness. Myopia has reached epidemic levels in urbanized countries, reaching up to 90% of the teenage and young adult population in urban Asia. Myopia represents a significant socioeconomic burden and poses a risk for associated ocular diseases such as retinal detachment, choroidal neovascularization, and glaucoma. The economic and public health burden of myopia are growing disproportionately to the population, spurring interest in the development of therapies to prevent occurrence or progression. Myopia generally occurs because the eye grows too long, with onset and progression occurring from about ages 6 to 20. Though much is known about factors that influence eye growth, the exact mechanisms by which they do so have not been elucidated.
The goals of this study are to assess the short-term (10-50 minutes) effects of different magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid in children and adults, as well as to assess the recovery period. Choroidal thickness will be measured non-invasively following 10-50 minutes of monocular exposure to -5D to +5D of optical defocus induced by spectacle lenses. The hypothesis is that choroidal thickness will increase with increasing myopic defocus and decrease with increasing hyperopic defocus. The relationship between the magnitude of defocus and the magnitude and direction of choroidal thickness change will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induced myopic defocus | Experimental | Device: Plus powered optical lensSubjects will view a television through a lens that induces blur to the retina for one hour. Images of the eye will be captured every 10 minutes |
| No defocus | No intervention | –Subjects will view a television through a lens that induces no blur to the retina for one hour. Images of the eye will be captured every 10 minutes |
Who may qualify
- Ages
- 6 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 6 to 45 years of age (preliminary studies indicate that children under 6 cannot sit for imaging, and subjects over 45 do not respond to the optical defocus with expected choroidal thickness changes)
- Best corrected visual acuity of 20/25 or better in better-seeing eye
Key exclusion criteria (4 listed)
- Age younger than 6 years or older than 45
- Best corrected visual acuity worse than 20/25 in better-seeing eye
- Ocular pathology or prior ocular injury
- Heavily-pigmented choroid that precludes accurate measurement of choroidal thickness
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 |
|---|---|---|
| Plus powered optical lensA plus powered optical lens will be placed in front of one eye. | Device | Induced myopic defocus |
Primary outcome
Choroidal thickness
Time frame: 1 hour
Changes in choroidal thickness following induced myopic defocus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: Yes. IPD will be provided by request once published
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plus powered optical lens in people with Induced Defocus to the Retina, run by University of Houston at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 17 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Choroidal thickness (time frame: 1 hour). 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 17 Mar 2022.