MyopiaNISDONCT05134935
Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Children Aged 6-12 Years.
A study testing Defocus Incorporated Multiple Segment (DIMS) Spectacles and Orthokerathology lenses (OKL) in people with Myopia, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The goal of this non-inferiority randomized clinical trial is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in myopic children aged 6-12 years. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- Defocus Incorporated Multiple Segment (DIMS) Spectacles and Orthokerathology lenses (OKL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Jun 2022to 2 Dec 2025
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Myopic children aged 6 to 12 years: Myopia of the 6 to 8-year-olds (inclusive): -1.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
- Myopia of the 9 to 12-year-olds (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
- Anisometropia ≤ 1.50 D cycloplegic spherical equivalent refractive error.
- Best corrected visual acuity at age 6 to 12 years (inclusive): 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: 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.
The goal of this non-inferiority randomized clinical trial is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in myopic children aged 6-12 years. The main question it aims to answer is:
- Is the DIMS spectacle lens not worse than the OKL after 18 months of therapy?
The participants are randomly assigned to either OKL or DIMS spectacles and followed during 18 months of therapy.
- Conditions
- Myopia
- Being tested
- Defocus Incorporated Multiple Segment (DIMS) Spectacles, Orthokerathology lenses (OKL)
- 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 (DIMS) SpectaclesDevice
Also called Defocus (DIMS) Spectacles
18 months of therapy.
Orthokerathology lenses (OKL)Device
Also called Night lenses
18 months of therapy.
| Study group | Role | What they receive |
|---|---|---|
| OKL | Active comparator | Not described Receives: Device: Orthokerathology lenses (OKL) |
| DIMS | Experimental | Not described Receives: Device: Defocus Incorporated Multiple Segment (DIMS) Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length growth of the eye
Length in mm is measured 18 months after therapy
Measured: 18 months
Secondary outcomes (1)
Overall eye length growth, defined as the sum of axial length and choroidal thickness
Length in mm is measured 18 months after therapy
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start29 Jun 2022
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT05134935
- Sponsor's protocol ID
- NISDO
- Acronym
- NISDO
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2021
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersen LC, Mejldal A, Sivakumar S, Jakobsen TM, Moller F. Defocus incorporated multiple segment spectacle lenses versus orthokeratology lenses for myopia control: a non-inferiority randomised clinical trial. BMC Ophthalmol. 2026 Aug 12;26(1):488. doi: 10.1186/s12886-026-05144-6.
PubMed 42595991
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT05134935
- Acronym / sponsor ID
- NISDO / NISDO
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 26 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 goal of this non-inferiority randomized clinical trial is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in myopic children aged 6-12 years. The main question it aims to answer is:
- Is the DIMS spectacle lens not worse than the OKL after 18 months of therapy?
The participants are randomly assigned to either OKL or DIMS spectacles and followed during 18 months of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OKL | Active comparator | Device: Orthokerathology lenses (OKL) |
| DIMS | Experimental | Device: Defocus Incorporated Multiple Segment (DIMS) Spectacles |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Myopic children aged 6 to 12 years: Myopia of the 6 to 8-year-olds (inclusive): -1.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
- Myopia of the 9 to 12-year-olds (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
- Anisometropia ≤ 1.50 D cycloplegic spherical equivalent refractive error.
- Best corrected visual acuity at age 6 to 12 years (inclusive): 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 (DIMS) SpectaclesAlso: Defocus (DIMS) Spectacles18 months of therapy. | Device | DIMS |
| Orthokerathology lenses (OKL)Also: Night lenses18 months of therapy. | Device | OKL |
Primary outcome
Axial length growth of the eye
Time frame: 18 months
Length in mm is measured 18 months after therapy
1 secondary outcome
Overall eye length growth, defined as the sum of axial length and choroidal thickness
Time frame: 18 months
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 7 Jan 2026.
- Derived from this study: PubMed 42595991Andersen LC, Mejldal A, Sivakumar S, Jakobsen TM, Moller F. Defocus incorporated multiple segment spectacle lenses versus orthokeratology lenses for myopia control: a non-inferiority randomised clinical trial. BMC Ophthalmol. 2026 Aug 12;26(1):488. doi: 10.1186/s12886-026-05144-6.
- Individual participant dataSharing planned: No
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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 (DIMS) Spectacles and Orthokerathology lenses (OKL) 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 7 Jan 2026. 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?
Axial length growth of the eye (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134935, which also lists 1 linked publication.
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 7 Jan 2026.