MyopiaTIDOCTNCT06234189
The Immediate Effect of Defocus Spectacles On the Choroid Thickness Using Optical Coherence Tomography on Children
A study testing Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) in people with Myopia, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The purpose is to examine temporary changes in the subfoveal choroid thickness after removal and after resumed use of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2024to 7 Mar 2024
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Myopic children using Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) from the ongoing randomized clinical non-inferiority study: "Defocus Incorporated Multiple Segment (DIMS) Spectacle Lenses versus Orthokeratology lenses (OKL) for slowing myopia progression in children aged 6-12 years. A non-inferiority randomized clinical trial. The NISDO study" (ClinicalTrials.gov Identifier NCT05134935).
- Myopia at the time of inclusion in the NISDO study (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
- Anisometropia at the time of inclusion in the NISDO study ≤ 1.50 D cycloplegic spherical equivalent refractive error.
- Best corrected visual acuity (inclusive) at the time of inclusion in the NISDO study: 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters).
Who cannot join
- Manifest or intermittent squint.
- Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic allergic conjunctivitis, and keratoconjunctivitis sicca.
- Previous eye surgery.
- Chronic eye disease demanding daily use of eye drops.
- Non-compliance to eye examinations (unstable fixation or anxiety towards contact lenses).
- Previous myopia control treatment.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Ophthalmic department, Vejle Hospital
Vejle, Southern Denmark, 7100
About this study
Official title: The Immediate Effect of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) on the Choroid Thickness Using Swept Source-Optical Coherence Tomography (SS-OCT) on Children.
The purpose is to examine temporary changes in the subfoveal choroid thickness after removal and after resumed use of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS).
- Conditions
- Myopia
- Being tested
- Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)Device
30 minutes without DIMS and 30 minutes with DIMS
| Study group | Role | What they receive |
|---|---|---|
| Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) | Experimental | Not described Receives: Device: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Thickness is measured in um
Measured: During 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Feb 2024
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lou-Ann Andersen, Principal investigator, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234189
- Sponsor's protocol ID
- TIDOCT
- Acronym
- TIDOCT
- Status last verified
- Jun 2025
- First submitted
- 22 Jan 2024
- Last updated
- 25 Jun 2025
- Results posted
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) on the Choroid Thickness Using Swept Source-Optical Coherence Tomography (SS-OCT) on Children.
- ClinicalTrials.gov ID
- NCT06234189
- Acronym / sponsor ID
- TIDOCT / TIDOCT
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 31 Jan 2024 (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 purpose is to examine temporary changes in the subfoveal choroid thickness after removal and after resumed use of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) | Experimental | Device: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Myopic children using Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) from the ongoing randomized clinical non-inferiority study: "Defocus Incorporated Multiple Segment (DIMS) Spectacle Lenses versus Orthokeratology lenses (OKL) for slowing myopia progression in children aged 6-12 years. A non-inferiority randomized clinical trial. The NISDO study" (ClinicalTrials.gov Identifier NCT05134935).
- Myopia at the time of inclusion in the NISDO study (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
- Anisometropia at the time of inclusion in the NISDO study ≤ 1.50 D cycloplegic spherical equivalent refractive error.
- Best corrected visual acuity (inclusive) at the time of inclusion in the NISDO study: 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters).
Key exclusion criteria (6 listed)
- Manifest or intermittent squint.
- Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic allergic conjunctivitis, and keratoconjunctivitis sicca.
- Previous eye surgery.
- Chronic eye disease demanding daily use of eye drops.
- Non-compliance to eye examinations (unstable fixation or anxiety towards contact lenses).
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 |
|---|---|---|
| Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)30 minutes without DIMS and 30 minutes with DIMS | Device | Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) |
Primary outcome
Choroidal thickness
Time frame: During 60 minutes
Thickness is measured in um
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 25 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Myopia
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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.
Lou-Ann Andersen principal investigator
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) in people with Myopia, run by Vejle Hospital at 1 site in Denmark.
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 4 inclusion and 6 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 25 Jun 2025. 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 Denmark. 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: During 60 minutes). 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 25 Jun 2025.