MyopiaNCT02206217
Myopia Control With the Multi-segment Lens
A study testing Multiple-Segment spectacle lens in people with Myopia, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can slow myopia progression in Hong Kong schoolchildren. MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Multiple-Segment spectacle lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child
Who may be able to join
- Age at enrolment: 8-13 year
- Spherical equivalent refractions (SER): -1.00 to -5.00 Dioptres (D)
- Astigmatism and anisometropia of 1.50 D or less
- Spectacle corrected monocular logMAR visual acuity: 0 or better
- Parents' understanding and acceptance of random allocation of grouping
Who cannot join
- any ocular and systemic abnormalities might affect visual functions or refractive development
- prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site
Centre for Myopia Research, The Hong Kong Polytechnic University
Hong Kong
Hong Kong1 site
Centre for Myopia Research, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens
The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can slow myopia progression in Hong Kong schoolchildren.
MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens
Read the detailed description
MS lens is a novel lens designed in attempt to slow myopia progression. It is a multifocal spectacle lens which corrects distance refractive error and at the same time produces myopic defocus images on the retina for all distances. The myopic defocus aims at slowing down myopia progression. The purpose of this study is to investigate if the MS lens can slow myopia progression in Hong Kong Chinese schoolchildren. The subjects will be randomly assigned to either treatment group (wear MS lenses) or control group (wear ordinary single vision lenses). Their cycloplegic refraction and axial length will be monitored every six months over 2 years. The changes in refractive errors and axial length in two groups will be compared.
- Conditions
- Myopia
- Being tested
- Multiple-Segment spectacle lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple-Segment spectacle lensDevice
Also called MS lens
A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.
| Study group | Role | What they receive |
|---|---|---|
| Single vision spectacle lens | No intervention | Single vision lens with power for correcting distance refraction. |
| Multiple-Segment spectacle lens | Experimental | A multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time. Receives: Device: Multiple-Segment spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic Refraction Change in SER
Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
Measured: Baseline and 2 years
Secondary outcomes (1)
Axial Length
Axial length (mm) was measured after cycloplegia using IOL Master
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Hoya Vision Care
- Responsible party
- Principal investigator, Carly Lam, The Hong Kong Polytechnic University
- Investigators
- Carly SY Lam, PhD, Principal investigator, The Hong Kong Polytechnic UniversityChi ho To, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206217
- Sponsor's protocol ID
- H-ZG3B
- Status last verified
- Jun 2020
- First submitted
- 29 Jul 2014
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29.
PubMed 31142465Chun RKM, Zhang H, Liu Z, Tse DYY, Zhou Y, Lam CSY, To CH. Defocus incorporated multiple segments (DIMS) spectacle lenses increase the choroidal thickness: a two-year randomized clinical trial. Eye Vis (Lond). 2023 Sep 15;10(1):39. doi: 10.1186/s40662-023-00356-z.
PubMed 37715201Lam CSY, Tang WC, Zhang HY, Lee PH, Tse DYY, Qi H, Vlasak N, To CH. Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years. Sci Rep. 2023 Apr 4;13(1):5475. doi: 10.1038/s41598-023-32700-7.
PubMed 37015996
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens
- ClinicalTrials.gov ID
- NCT02206217
- Acronym / sponsor ID
- H-ZG3B
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Hoya Vision Care
- Study start
- Aug 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Posted 31 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can slow myopia progression in Hong Kong schoolchildren.
MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens
Detailed description
MS lens is a novel lens designed in attempt to slow myopia progression. It is a multifocal spectacle lens which corrects distance refractive error and at the same time produces myopic defocus images on the retina for all distances. The myopic defocus aims at slowing down myopia progression. The purpose of this study is to investigate if the MS lens can slow myopia progression in Hong Kong Chinese schoolchildren. The subjects will be randomly assigned to either treatment group (wear MS lenses) or control group (wear ordinary single vision lenses). Their cycloplegic refraction and axial length will be monitored every six months over 2 years. The changes in refractive errors and axial length in two groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single vision spectacle lens | No intervention | –Single vision lens with power for correcting distance refraction. |
| Multiple-Segment spectacle lens | Experimental | Device: Multiple-Segment spectacle lensA multifocal spectacle lens that corrects distance refraction and provides myopic defocus at the same time. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age at enrolment: 8-13 year
- Spherical equivalent refractions (SER): -1.00 to -5.00 Dioptres (D)
- Astigmatism and anisometropia of 1.50 D or less
- Spectacle corrected monocular logMAR visual acuity: 0 or better
- Parents' understanding and acceptance of random allocation of grouping
Key exclusion criteria (2 listed)
- any ocular and systemic abnormalities might affect visual functions or refractive development
- prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
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 |
|---|---|---|
| Multiple-Segment spectacle lensAlso: MS lensA multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression. | Device | Multiple-Segment spectacle lens |
Primary outcome
Cycloplegic Refraction Change in SER
Time frame: Baseline and 2 years
Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.
1 secondary outcome
Axial Length
Time frame: Baseline and 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31142465Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29.
- Derived from this study: PubMed 37715201Chun RKM, Zhang H, Liu Z, Tse DYY, Zhou Y, Lam CSY, To CH. Defocus incorporated multiple segments (DIMS) spectacle lenses increase the choroidal thickness: a two-year randomized clinical trial. Eye Vis (Lond). 2023 Sep 15;10(1):39. doi: 10.1186/s40662-023-00356-z.
- Derived from this study: PubMed 37015996Lam CSY, Tang WC, Zhang HY, Lee PH, Tse DYY, Qi H, Vlasak N, To CH. Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years. Sci Rep. 2023 Apr 4;13(1):5475. doi: 10.1038/s41598-023-32700-7.
- 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.
Carly SY Lam, PhD principal investigator
The Hong Kong Polytechnic University
Chi ho To, PhD principal investigator
The Hong Kong Polytechnic University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple-Segment spectacle lens in people with Myopia, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
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 5 inclusion and 2 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 2 Jul 2020. 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, Hong Kong. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cycloplegic Refraction Change in SER (time frame: Baseline and 2 years). 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 NCT02206217, which also lists 3 linked publications.
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 2 Jul 2020.