MyopiaBLMCNCT07511387
Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children
A study testing BCMC lens in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study aims to evaluate the short-term efficacy and safety of a novel, proprietary spectacle lens. Forty myopic participants, aged 6 to 15 years, will be prescribed with the study spectacles for a period of six months. All subjects will be required to attend five scheduled visits. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- BCMC lens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Apr 2026to Mar 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6 to 15 years (Chinese), inclusive
- Cycloplegic SER between -0.75 D and -6.00 D in both eyes
- Astigmatism ≤ 2.00 D in both eyes
- Anisometropia ≤ 1.50 D
- BCVA of 0.04 logMAR or better in each eye
Who cannot join
- Previous or current use of any myopia control intervention within 6 months
- Presence of any ocular pathology, amblyopia, colour vision deficiency or strabismus that could affect refractive development or visual function
- History of ocular surgery or significant ocular trauma
- Known systemic diseases or use of medications that could affect vision or ocular growth
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Optometry, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: A Pilot Study on the Short-Term Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children
This study aims to evaluate the short-term efficacy and safety of a novel, proprietary spectacle lens. Forty myopic participants, aged 6 to 15 years, will be prescribed with the study spectacles for a period of six months. All subjects will be required to attend five scheduled visits. Change in subfoveal choroidal thickness (SfChT), axial length and refraction will be determined.
Read the detailed description
Optical strategies have been shown to be effective for slowing myopia progression. The design of the BLMCL patented spectacle lens is based on existing myopic control theory of peripheral defocus spectacle lenses. This prospective, observational cohort study aims to evaluate the short-term efficacy and safety of the BLMCL lens in school-aged children. Forty participants, aged 6 to 15 years with SER between -6.00D to -0.75D and astigmatism not more than -2.00D, will be fitted with the BLMCL Lens and followed for six months. They will be required to return for five scheduled visits: baseline, delivery, 1 month, 3 months, and 6 months after lens delivery visits. The primary endpoint is the change in subfoveal choroidal thickness (SfChT) for potential effective myopia control via SfChT thickening. The secondary endpoints are the changes in AL and refraction after cycloplegia which allow comparison with other myopia control studies. Subjective symptoms will be assessed using the PREP2 and QoV questionnaires.
- Conditions
- Myopia
- Being tested
- BCMC lens
- Keywords
- Myopia, Children, Myopia control, Spectacle lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMC lensOther
BLMC spectacle lens is a spectacle lens that corrects the distance refraction and provides defocus in peripheral region
| Study group | Role | What they receive |
|---|---|---|
| BLMC lenses | Experimental | Participants will be prescribed with a pair of study spectacle lenses for six months Receives: Other: BCMC lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subfoveal choroidal thickness (SfChT)
SfChT will be measured using Swept-Source OCT (SS-OCT) without cycloplegia. It will be measured at the delivery visit before dispensing, and 1, 3 and 6 months after delivery. In order to minimize the effect of diurnal variation, it will be measured within two hours hours from the first measurement at the delivery visit. Two good quality images will be captured for each eye. Segmentation of the images will be performed by a masked examiner. Changes in SfChT after using the lenses for 1, 3, and 6 months will be determined.
Measured: Delivery and 1, 3, and 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start10 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (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.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, LAM Chuen Thomas, FAAO, PhD, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511387
- Sponsor's protocol ID
- 20260302008
- Acronym
- BLMC
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Short-Term Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children
- ClinicalTrials.gov ID
- NCT07511387
- Acronym / sponsor ID
- BLMC / 20260302008
- Conditions
- Myopia
- Keywords
- Myopia, Children, Myopia control, Spectacle lenses
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Apr 2026 (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 study aims to evaluate the short-term efficacy and safety of a novel, proprietary spectacle lens. Forty myopic participants, aged 6 to 15 years, will be prescribed with the study spectacles for a period of six months. All subjects will be required to attend five scheduled visits. Change in subfoveal choroidal thickness (SfChT), axial length and refraction will be determined.
Detailed description
Optical strategies have been shown to be effective for slowing myopia progression. The design of the BLMCL patented spectacle lens is based on existing myopic control theory of peripheral defocus spectacle lenses. This prospective, observational cohort study aims to evaluate the short-term efficacy and safety of the BLMCL lens in school-aged children. Forty participants, aged 6 to 15 years with SER between -6.00D to -0.75D and astigmatism not more than -2.00D, will be fitted with the BLMCL Lens and followed for six months. They will be required to return for five scheduled visits: baseline, delivery, 1 month, 3 months, and 6 months after lens delivery visits. The primary endpoint is the change in subfoveal choroidal thickness (SfChT) for potential effective myopia control via SfChT thickening. The secondary endpoints are the changes in AL and refraction after cycloplegia which allow comparison with other myopia control studies. Subjective symptoms will be assessed using the PREP2 and QoV questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLMC lenses | Experimental | Other: BCMC lensParticipants will be prescribed with a pair of study spectacle lenses for six months |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6 to 15 years (Chinese), inclusive
- Cycloplegic SER between -0.75 D and -6.00 D in both eyes
- Astigmatism ≤ 2.00 D in both eyes
- Anisometropia ≤ 1.50 D
- BCVA of 0.04 logMAR or better in each eye
Key exclusion criteria (4 listed)
- Previous or current use of any myopia control intervention within 6 months
- Presence of any ocular pathology, amblyopia, colour vision deficiency or strabismus that could affect refractive development or visual function
- History of ocular surgery or significant ocular trauma
- Known systemic diseases or use of medications that could affect vision or ocular growth
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 |
|---|---|---|
| BCMC lensBLMC spectacle lens is a spectacle lens that corrects the distance refraction and provides defocus in peripheral region | Other | BLMC lenses |
Primary outcome
Change in subfoveal choroidal thickness (SfChT)
Time frame: Delivery and 1, 3, and 6 months after delivery
SfChT will be measured using Swept-Source OCT (SS-OCT) without cycloplegia. It will be measured at the delivery visit before dispensing, and 1, 3 and 6 months after delivery. In order to minimize the effect of diurnal variation, it will be measured within two hours hours from the first measurement at the delivery visit. Two good quality images will be captured for each eye. Segmentation of the images will be performed by a masked examiner. Changes in SfChT after using the lenses for 1, 3, and 6 months will be determined.
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 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCMC lens in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 4 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 3 Jun 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 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?
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?
Change in subfoveal choroidal thickness (SfChT) (time frame: Delivery and 1, 3, and 6 months after delivery). 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 3 Jun 2026.