MyopiaPDIMSNCT06717035
Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children
A study testing EYE001 in people with Myopia and Myopia Progression, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Myopia, Myopia Progression
- What is being tested?
- EYE001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Jan 2025to 2 Jan 2027
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must meet all the criteria listed to participate in the study:
- All ethnicities
- Age between 6 and 15 years
- Refraction -0.50D till - 7.00D and astigmatism ≤ 3.00D
- Anisometropia ≤ 3.00D
- Best corrected monocular distance high contrast VA ≤ 0.10 logMAR
- Normal Binocular vision (fusion and stereopsis)
Who cannot join
- All subjects meeting any of the exclusion criteria at baseline will be excluded from participation:
- Ocular and systemic abnormalities
- Children who do not cooperate
- Binocular vision anomalies (strabismus, suppression)
- Previous use of myopia management treatment (spectacles, atropine, CLs)
- Neurological disorders
Show all 11Show fewer
- Premature infants
- Children who do not wear their glasses correctly for intermediate and near vision activities
- Children who do not meet the inclusion criteria
- No informed consent given by parents of child for participation in the clinical study
- Subject is allergic to cycloplegic eye drops
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
Singapore National Eye Centre
Singapore, 159029
Bryan Sim, MBBS FRCOphth, 97722192, bryansimxr@hotmail.com
About this study
Official title: Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children.
This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.
Read the detailed description
Myopia now is recognized as one of the important public health problems and myopia prevention and control has become more important. Various myopia management strategies have been tested in the past for the control of myopia progression in children. In recent years, various optical interventions have also been explored to manage myopia, including the use of optical, pharmaceutical, and lifestyle interventions. Spectacles, atropine eye drops, and outdoor activities have shown some efficacy in slowing myopia progression, but the optimal approach to delaying or preventing the onset of myopia in at-risk populations remains a challenge. These myopia management modalities are often also labelled as invasive and non-invasive methods. One of the non-invasive myopia management modalities includes spectacles.
DIMS spectacle lenses are based on creating myopic defocus at the mid-periphery of the retina which would provide a cue of axial length elongation control. DIMS is a spectacle lens with a central optical zone of 9.4 mm for correcting distance myopic refractive errors and a mid-peripheral 33mm of treatment zone with multiple segments of 1 mm diameter, each segment provides defocus of + 3.5D. 2-year Randomised Controlled Trial (RCT) showed 52% reduction in myopia progression and 62% slow down effect in axial elongation in children wearing DIMS spectacle lenses compared to those on single vision spectacle lens correction at the end of 2-year follow-up in Hong Kong children.
2-years RCT has been conducted using DIMS clear spectacle lenses, however, no studies have been conducted on photochromic and polarized version to show the non-inferiority of sun solutions compared to clear version in myopia management.
This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.
- Conditions
- Myopia, Myopia Progression
- Being tested
- EYE001
- Keywords
- Myopia, Spectacles, Glasses, Myopia Control, Pediatric, DIMS
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYE001Device
Also called Defocus incorporated multiple segments (DIMS) lenses
Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic
| Study group | Role | What they receive |
|---|---|---|
| Children on clear DIMS lenses | Active comparator | 202 children will be recruited at 6 institutions following the rules of inclusion and exclusion criteria. Based on a randomization process defined from the study coordinator, children will be allocated to 2 groups: DIMS and PDIMS. The study will be single blinded, meaning that the investigators are not aware of which type of treatment will be associated with which subjects. Subjects cannot be blinded due to the darkening of PDIMS that allows recognition on the type of lens. Receives: Device: EYE001 |
| Children on photochromic DIMS lenses | Active comparator | 202 children will be recruited at 6 institutions following the rules of inclusion and exclusion criteria. Based on a randomization process defined from the study coordinator, children will be allocated to 2 groups: DIMS and PDIMS. The study will be single blinded, meaning that the investigators are not aware of which type of treatment will be associated with which subjects. Subjects cannot be blinded due to the darkening of PDIMS that allows recognition on the type of lens. Receives: Device: EYE001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing photochromic DIMS spectacles lenses performance (PDIMS) versus clear DIMS spectacles lenses (DIMS)
The primary objective of this study is to evaluate the efficacy of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in terms of childhood myopia control (cycloplegic spherical equivalent refraction (SER), axial elongation and choroidal thickness).
Measured: 24 months
Secondary outcomes (1)
Performance of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS)
To assess the safety, tolerability (quality of life (QoL)), and adaptation to PDIMS lens wear compared to DIMS lens wear.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start2 Jan 2025 (estimated)
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Model description
- Randomization: 202 children will be recruited at 6 institutions following the rules of inclusion and exclusion criteria. Based on a randomization process defined from the study coordinator, children will be allocated to 2 groups: DIMS and PDIMS. The study will be single blinded, meaning that the investigators are not aware of which type of treatment will be associated with which subjects. Subjects cannot be blinded due to the darkening of PDIMS that allows recognition on the type of lens.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bryan Sim XR, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717035
- Sponsor's protocol ID
- SingaporeNEC
- Acronym
- PDIMS
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Change in spherical equivalent and axial length over time for further trials in future
Publications
Lam CS, Tang WC, Lee PH, Zhang HY, Qi H, Hasegawa K, To CH. Myopia control effect of defocus incorporated multiple segments (DIMS) spectacle lens in Chinese children: results of a 3-year follow-up study. Br J Ophthalmol. 2022 Aug;106(8):1110-1114. doi: 10.1136/bjophthalmol-2020-317664. Epub 2021 Mar 17.
PubMed 33731364Lam 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 31142465
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children.
- ClinicalTrials.gov ID
- NCT06717035
- Acronym / sponsor ID
- PDIMS / SingaporeNEC
- Conditions
- Myopia, Myopia Progression
- Keywords
- Myopia, Spectacles, Glasses, Myopia Control, Pediatric, DIMS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 4 Dec 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.
This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.
Detailed description
Myopia now is recognized as one of the important public health problems and myopia prevention and control has become more important. Various myopia management strategies have been tested in the past for the control of myopia progression in children. In recent years, various optical interventions have also been explored to manage myopia, including the use of optical, pharmaceutical, and lifestyle interventions. Spectacles, atropine eye drops, and outdoor activities have shown some efficacy in slowing myopia progression, but the optimal approach to delaying or preventing the onset of myopia in at-risk populations remains a challenge. These myopia management modalities are often also labelled as invasive and non-invasive methods. One of the non-invasive myopia management modalities includes spectacles.
DIMS spectacle lenses are based on creating myopic defocus at the mid-periphery of the retina which would provide a cue of axial length elongation control. DIMS is a spectacle lens with a central optical zone of 9.4 mm for correcting distance myopic refractive errors and a mid-peripheral 33mm of treatment zone with multiple segments of 1 mm diameter, each segment provides defocus of + 3.5D. 2-year Randomised Controlled Trial (RCT) showed 52% reduction in myopia progression and 62% slow down effect in axial elongation in children wearing DIMS spectacle lenses compared to those on single vision spectacle lens correction at the end of 2-year follow-up in Hong Kong children.
2-years RCT has been conducted using DIMS clear spectacle lenses, however, no studies have been conducted on photochromic and polarized version to show the non-inferiority of sun solutions compared to clear version in myopia management.
This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization: 202 children will be recruited at 6 institutions following the rules of inclusion and exclusion criteria. Based on a randomization process defined from the study coordinator, children will be allocated to 2 groups: DIMS and PDIMS. The study will be single blinded, meaning that the investigators are not aware of which type of treatment will be associated with which subjects. Subjects cannot be blinded due to the darkening of PDIMS that allows recognition on the type of lens.
| Arm | Type | Receives |
|---|---|---|
| Children on clear DIMS lenses | Active comparator | Device: EYE001202 children will be recruited at 6 institutions following the rules of inclusion and exclusion criteria. Based on a randomization process defined from the study coordinator, children will be allocated to 2 groups: DIMS and PDIMS. The study will be single blinded, meaning that the investigators are not aware of which type of treatment will be associated with which subjects. Subjects cannot be blinded due to the darkening of PDIMS that allows recognition on the type of lens. |
| Children on photochromic DIMS lenses | Active comparator | Device: EYE001202 children will be recruited at 6 institutions following the rules of inclusion and exclusion criteria. Based on a randomization process defined from the study coordinator, children will be allocated to 2 groups: DIMS and PDIMS. The study will be single blinded, meaning that the investigators are not aware of which type of treatment will be associated with which subjects. Subjects cannot be blinded due to the darkening of PDIMS that allows recognition on the type of lens. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- All ethnicities
- Age between 6 and 15 years
- Refraction -0.50D till - 7.00D and astigmatism ≤ 3.00D
- Anisometropia ≤ 3.00D
- Best corrected monocular distance high contrast VA ≤ 0.10 logMAR
Key exclusion criteria (11 listed)
- All subjects meeting any of the exclusion criteria at baseline will be excluded from participation:
- Ocular and systemic abnormalities
- Children who do not cooperate
- Binocular vision anomalies (strabismus, suppression)
- Previous use of myopia management treatment (spectacles, atropine, CLs)
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 |
|---|---|---|
| EYE001Also: Defocus incorporated multiple segments (DIMS) lensesDefocus incorporated multiple segments (DIMS) clear vs DIMS photochromic | Device | Children on clear DIMS lenses, Children on photochromic DIMS lenses |
Primary outcome
Comparing photochromic DIMS spectacles lenses performance (PDIMS) versus clear DIMS spectacles lenses (DIMS)
Time frame: 24 months
The primary objective of this study is to evaluate the efficacy of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in terms of childhood myopia control (cycloplegic spherical equivalent refraction (SER), axial elongation and choroidal thickness).
1 secondary outcome
Performance of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS)
Time frame: 24 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 4 Dec 2024.
- Background: PubMed 33731364Lam CS, Tang WC, Lee PH, Zhang HY, Qi H, Hasegawa K, To CH. Myopia control effect of defocus incorporated multiple segments (DIMS) spectacle lens in Chinese children: results of a 3-year follow-up study. Br J Ophthalmol. 2022 Aug;106(8):1110-1114. doi: 10.1136/bjophthalmol-2020-317664. Epub 2021 Mar 17.
- Background: 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.
- Individual participant dataSharing planned: Yes. Change in spherical equivalent and axial length over time for further trials in future
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EYE001 in people with Myopia and Myopia Progression, run by Singapore National Eye Centre at 1 site in Singapore.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 4 Dec 2024. 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 Singapore. 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?
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?
Contact Bryan Sim, MD FRCOphth (UK) (+6597722192, bryansimxr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing photochromic DIMS spectacles lenses performance (PDIMS) versus clear DIMS spectacles lenses (DIMS) (time frame: 24 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 NCT06717035, which also lists 2 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 4 Dec 2024.