MyopiaNCT06654180
Comparing Myopia Control Efficacy in Children With 4 Methods: Orthokeratology, DIMS, DISK, and SVS.
A study testing Orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles and DISK in people with Myopia, run by Kaikai QIU at 2 sites in China.
Trial summary
The goal of this clinical trial is to learn if 3 optical interventions（DIMS, DISC and orthokeratology) to control myopia have different efficacy to slow myopia progression in children when the control is single focus spectacles(SVS). It will also learn about the safety of all 4 interventions. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Myopia
- What is being tested?
- Orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles and DISK
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 21 Oct 2022to 10 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Must agree to participate in the study
- Must have cycloplegic refraction with spherical equivalent refractive (SER)
- - 2.00 D ~ - 5.00 D (including the boundary values)
- Clinical diagnosis of astigmatism was ≤ 1.00D
- Must be able to have corrected visual acuity ≤ 0.00 logMAR of either eye
- Must be able to wear either of SVS/DIMS/DISC/Orthokeratology lenses and kept the same intervention for 12 month
- Must have the front cornea curve value between 41.00D~44.00D
- Must have axial length of the study eye between 23.00mm and 25.00mm at baseline
Who cannot join
- Dry eye
- keratitis
- Conjunctivitis
- Clinical diagnosis of entropion
- Clinical diagnosis of glaucoma
- Clinical diagnosis of retinal lesions
Show all 14Show fewer
- Clinical diagnosis of amblyopia
- Clinical diagnosis of optic media lesions (e.g., central thick corneal scars, cataract)
- Clinical diagnosis of optic nerve dysfunction
- Have medical history of atropine eyedrops (including 1% high concentration , 0.05%, 0.01% or other low concentration)
- Have history of wearing peripheral defocus spectacles
- Have history of wearing duo-focal soft contact lenses
- Unable to follow up
- Investigators consider to be not eligible.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Ningbo Eye Hospital
Ningbo, Zhejiang, 315000
Optometry department, Ningbo Eye Hospital
Ningbo, Zhejiang, 315000
About this study
Official title: A Comparison of Myopia Control Efficacy in Children With Orthokeratology, Defocus Incorporated Multiple Segment (DIMS) Spectacles, Defocus Incorporated Soft Contact (DISK) Lenses, and Single-vision Spectacles for 12 Months
The goal of this clinical trial is to learn if 3 optical interventions（DIMS, DISC and orthokeratology) to control myopia have different efficacy to slow myopia progression in children when the control is single focus spectacles(SVS). It will also learn about the safety of all 4 interventions. The main questions it aims to answer are:
Does orthokeratology slows the progressing myopia more significant than the DIMS or DISK? What medical problems do participants have when taking orthokeratology, DIMS and DISK? Researchers will compare all the 3 interventions to a placebo (SVS) to see if 3 interventions has significant difference in slow the axial length elongation as well as the refraction changes.
Read more
Participants will:
Take orthokeratology, DIMS, DISK or SVS every day for 12 months Visit the clinic once every 3 months for checkups and tests.
Read the detailed description
orthokeratology and DISK are contact lenses, while DIMS and SVS are spectacles.
- Conditions
- Myopia
- Being tested
- Orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles, DISK, Single-focus spectacles
- Keywords
- Myopia, Children
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthokeratologyDevice
Also called DIMS, DISK, SVS
Orthokeratology is to a rigid contact lens with reverse design to flat the central cornea to correct the myopia, which is to use at night during sleep; DIMS and SVS are both spectacles to wear at daytime; DIMS has many tiny lenses at peripheral of the big lenses to make the peripheral retina myopic defocus during the daytime; SVS has only one focus while DIMS has many focuses made by the tiny segments lenses around the peripheral vision fields; DISK is a soft contact lens with peripheral myopic power design to make the myopic eyes defocus at peripheral during the daytime.
defocus-incorporated multiple segment lenses (DIMS) spectaclesDevice
It is the special lenses with peripheral lots of tiny segments of plus lenses around the center
DISKDevice
SVS
Single-focus spectaclesDevice
Myopic Glasses with mono-focus in each eye
| Study group | Role | What they receive |
|---|---|---|
| Orthokeratology | Active comparator | To wear Orthokeratology at night to slow down progressing myopia Receives: Device: Orthokeratology |
| defocus-incorporated multiple segment lenses (DIMS) spectacles | Experimental | To wear defocus-incorporated multiple segment lenses (DIMS) spectacles at daytime Receives: Device: defocus-incorporated multiple segment lenses (DIMS) spectacles |
| defocus incorporated soft contact (DISK) lenses | Experimental | To wear defocus incorporated soft contact (DISK) lenses at daytime Receives: Device: DISK |
| single-vision spectacles (SVS) | Placebo comparator | To wear SVS at daytime and at night before sleep Receives: Device: Single-focus spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of axial length for 12-month (mm)
The ocular axial length change at follow-up of 12-month from baseline with IOLmaster 500（IOLMaster 500, Carl Zeiss Meditec AG, Germany) in the unit of millimetre
Measured: 12 months
Secondary outcomes (5)
Changes of Spherical Equivalence Refraction (D)
Changes of SER at 12-Month follow-up with cycloplegic refraction (Diopter, D) with the auto refractometer (Topcon KR-800, Topcon Corporation, Tokyo, Japan)
Measured: 12 months
Dropout rate (%)
The dropout rate of each group with the percentage (%) record by the formula =the dropout number versus total number of the each group *100%.
Measured: 12 months
Changes of ocular axial length at follow-up of 3 months (mm)
Changes of ocular axial length at follow-up of 3 month from baseline with the IOLmaster 500(millimetre, mm)
Measured: 3 months
Changes of ocular axial length at follow-up of 6 months (mm)
Changes of ocular axial length at follow-up of 6 month from baseline with the IOLmaster 500(millimetre, mm)
Measured: 6 months
Changes of ocular axial length at follow-up of 9 months (mm)
Changes of ocular axial length at follow-up of 9 month from baseline with the IOLmaster 500(millimetre, mm)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start21 Oct 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion10 Dec 2031 (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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaikai QIU
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Eye Hospital
- Responsible party
- Sponsor-investigator, Kaikai QIU, Fuzhou Southeast Institute of Visual Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654180
- Sponsor's protocol ID
- Southeast Eye Institute
- Other IDs
- MR-33-22-012252
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The explanation why IPD will not be shared is that almost all the data to be obtained is on another clinic center with another external site. The data is confidential to obtain to outside system with complete details.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Myopia Control Efficacy in Children With Orthokeratology, Defocus Incorporated Multiple Segment (DIMS) Spectacles, Defocus Incorporated Soft Contact (DISK) Lenses, and Single-vision Spectacles for 12 Months
- ClinicalTrials.gov ID
- NCT06654180
- Acronym / sponsor ID
- Southeast Eye Institute
- Conditions
- Myopia
- Keywords
- Myopia, Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaikai QIUUniversity, hospital or other
- Collaborators
- Ningbo Eye Hospital
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 10 Dec 2031 (estimated)
- First posted
- 23 Oct 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 goal of this clinical trial is to learn if 3 optical interventions（DIMS, DISC and orthokeratology) to control myopia have different efficacy to slow myopia progression in children when the control is single focus spectacles(SVS). It will also learn about the safety of all 4 interventions. The main questions it aims to answer are:
Does orthokeratology slows the progressing myopia more significant than the DIMS or DISK? What medical problems do participants have when taking orthokeratology, DIMS and DISK? Researchers will compare all the 3 interventions to a placebo (SVS) to see if 3 interventions has significant difference in slow the axial length elongation as well as the refraction changes.
Participants will:
Take orthokeratology, DIMS, DISK or SVS every day for 12 months Visit the clinic once every 3 months for checkups and tests.
Detailed description
orthokeratology and DISK are contact lenses, while DIMS and SVS are spectacles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Orthokeratology | Active comparator | Device: OrthokeratologyTo wear Orthokeratology at night to slow down progressing myopia |
| defocus-incorporated multiple segment lenses (DIMS) spectacles | Experimental | Device: defocus-incorporated multiple segment lenses (DIMS) spectaclesTo wear defocus-incorporated multiple segment lenses (DIMS) spectacles at daytime |
| defocus incorporated soft contact (DISK) lenses | Experimental | Device: DISKTo wear defocus incorporated soft contact (DISK) lenses at daytime |
| single-vision spectacles (SVS) | Placebo comparator | Device: Single-focus spectaclesTo wear SVS at daytime and at night before sleep |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Must agree to participate in the study
- Must have cycloplegic refraction with spherical equivalent refractive (SER)
- Clinical diagnosis of astigmatism was ≤ 1.00D
- Must be able to have corrected visual acuity ≤ 0.00 logMAR of either eye
- Must be able to wear either of SVS/DIMS/DISC/Orthokeratology lenses and kept the same intervention for 12 month
Key exclusion criteria (14 listed)
- Dry eye
- keratitis
- Conjunctivitis
- Clinical diagnosis of entropion
- Clinical diagnosis of glaucoma
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 |
|---|---|---|
| OrthokeratologyAlso: DIMS, DISK, SVSOrthokeratology is to a rigid contact lens with reverse design to flat the central cornea to correct the myopia, which is to use at night during sleep; DIMS and SVS are both spectacles to wear at daytime; DIMS has many tiny lenses at peripheral of the big lenses to make the peripheral retina myopic defocus during the daytime; SVS has only one focus while DIMS has many focuses made by the tiny segments lenses around the peripheral vision fields; DISK is a soft contact lens with peripheral myopic power design to make the myopic eyes defocus at peripheral during the daytime. | Device | Orthokeratology |
| defocus-incorporated multiple segment lenses (DIMS) spectaclesIt is the special lenses with peripheral lots of tiny segments of plus lenses around the center | Device | defocus-incorporated multiple segment lenses (DIMS) spectacles |
| DISKSVS | Device | defocus incorporated soft contact (DISK) lenses |
| Single-focus spectaclesMyopic Glasses with mono-focus in each eye | Device | single-vision spectacles (SVS) |
Primary outcome
Changes of axial length for 12-month (mm)
Time frame: 12 months
The ocular axial length change at follow-up of 12-month from baseline with IOLmaster 500（IOLMaster 500, Carl Zeiss Meditec AG, Germany) in the unit of millimetre
5 secondary outcomes
Changes of Spherical Equivalence Refraction (D)
Time frame: 12 months
Dropout rate (%)
Time frame: 12 months
Changes of ocular axial length at follow-up of 3 months (mm)
Time frame: 3 months
Changes of ocular axial length at follow-up of 6 months (mm)
Time frame: 6 months
Changes of ocular axial length at follow-up of 9 months (mm)
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No. The explanation why IPD will not be shared is that almost all the data to be obtained is on another clinic center with another external site. The data is confidential to obtain to outside system with complete details.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles and DISK in people with Myopia, run by Kaikai QIU at 2 sites in China.
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 14 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes of axial length for 12-month (mm) (time frame: 12 months). 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 23 Oct 2024.