MyopiaNCT04813640
Eye Length Signal With Myopia Control
A study testing Spectacles in people with Myopia, run by Brien Holden Vision Institute at 1 site in Vietnam.
Trial summary
Myopia, considered as a global epidemic, is rapidly rising in prevalence especially in east Asian countries. Younger ages are associated with greater annual progression and thus early onset myopia is likely to result in higher levels of final net myopia.[1] Myopia, especially high myopia (more than -6.00D) is… Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 5 Feb 2021to 31 Oct 2021
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- be aged between 7 to 14 completed years (7 and 14 years inclusive), irrespective of gender.
- have cycloplegic autorefraction spherical component -0.50 D to - 4.50D, cylinder no more than -1.50D
- be accompanied by parents/guardians who can read and comprehend Vietnamese and give informed consent as demonstrated by signing a record of informed consent.
- be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
- have ocular health findings considered to be "normal".
- be correctable to at least 6/9.5 (20/30) or better in each eye with spectacles.
- be willing to wear the spectacles provided by the investigators for all waking hours;
Who cannot join
- A known allergy to, or a history of intolerance to tropicamide or topical anaesthetics;
- Strabismus and/or amblyopia;
- Had previous eye surgery (including strabismus surgery);
- Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes;
- Had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids;
- Worn bifocals or progressive addition spectacles;
Show all 11Show fewer
- Worn orthokeratology or bifocal contact lenses;
- Current orthoptic treatment or vision training;
- Any anatomical, skin or other condition that would impact on the wearing of spectacles;
- Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
- Concurrently enrolled in another clinical trial.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Hai Yen Eye Care Center
Ho Chi Minh City
Minh Huy Tran, MD, MSc, (+84) 907110892, huy.Tran@haiyeneyecare.com
About this study
Official title: A Prospective, Randomised, Dispensing Clinical Trial to Compare the Visual Performance, Wearability and Ocular Response of Myopia Control, Novel Myopia Control and Single Vision Spectacle Lenses
Myopia, considered as a global epidemic, is rapidly rising in prevalence especially in east Asian countries. Younger ages are associated with greater annual progression and thus early onset myopia is likely to result in higher levels of final net myopia.[1] Myopia, especially high myopia (more than -6.00D) is associated vision threatening complications such as cataract, glaucoma, choroidal thinning, vitreous liquefaction, myopic maculopathy, retinal detachment etc. Furthermore, myopia can affect the quality of life of an individual through restriction of employment in certain fields such as aviation. Myopia also imposes economic burden through the recurring cost of vision correction such as spectacles, contact lenses and specialist consultation fee. It is therefore important to develop novel optical and pharmaceutical strategies that can control or slow the progression of myopia.
Read the detailed description
To date, the strategies used to control or slow the progression of myopia are optical and pharmaceutical methods. Among spectacles, bifocal spectacles with and without prism, progressive addition lenses, spectacles altering peripheral hyperopic defocus, spectacles imposing myopic defocus both centrally and peripherally and spectacles with multiple defocus segments that imposes myopic defocus in front, midperiphery and periphery of the retina (defocus incorporating multiple segments or DIMS) are used to reduce the progression[2-6]. Of these, spectacles designed to alter peripheral defocus demonstrated a small treatment effect in reducing myopia progression[6, 7]. Bifocal and progressive addition spectacles demonstrated variable treatment effect in reducing progression of myopia. Among contact lenses, multifocal contact lenses altering peripheral defocus, extended depth of focus contact lenses altering higher order aberrations in order to degrade the retinal image behind the retina have shown promising results in slowing myopia progression along with orthokeratology treatment[8-12]. Among these, orthokeratology and multifocal soft contact lenses (centre distance multifocal contact lenses) showed promising results in slowing myopia progression[9, 12].
Pharmaceutical interventions include Atropine, Pirenzepine, 7-Methylxanthine and Timolol[13].Atropine is the most widely used, with higher concentrations more effective. Atropine 1% concentration demonstrated 60 to 80% reduction in progression of myopia. However, ocular side effects such as blurred vision, photophobia etc associated with atropine makes it a less appealing option. Among the various treatment approaches, spectacles pose the least or minimal side effects compared to contact lenses, orthokeratology or pharmaceutical strategies. Therefore, this study aims to determine the effect of novel myopia control prototype spectacle design on wearability and physiological ocular response among myopic children aged 7 to 14 years.
- Conditions
- Myopia
- Being tested
- Spectacles
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpectaclesDevice
Novel spectacles for myopia control
| Study group | Role | What they receive |
|---|---|---|
| Single Vision Spectacles | Placebo comparator | Commercially available conventional single vision spectacles Receives: Device: Spectacles |
| Commercially available myopia control spectacles | Active comparator | Commercially available myopia control spectacles Receives: Device: Spectacles |
| Novel Myopia control spectacles - Prototype I | Experimental | Experimental myopia control spectacles Receives: Device: Spectacles |
| Novel Myopia control spectacles - Prototype II | Experimental | Experimental myopia control spectacles Receives: Device: Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in axial length
Change in axial length measured using Lenstar
Measured: one monthly interval for up to 6 months
Secondary outcomes (1)
Vision and Choroidal Physiology
Vision and Choroidal Physiology determined using standard vision charts and Optical Coherence Tomography (OCT)
Measured: One monthly interval for up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start5 Feb 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brien Holden Vision Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minh Huy Tran, M.D., Msc., Principal investigator, Hai Yen Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813640
- Sponsor's protocol ID
- VCRTC2020-02
- Status last verified
- May 2021
- First submitted
- 4 Feb 2021
- Last updated
- 7 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Dispensing Clinical Trial to Compare the Visual Performance, Wearability and Ocular Response of Myopia Control, Novel Myopia Control and Single Vision Spectacle Lenses
- ClinicalTrials.gov ID
- NCT04813640
- Acronym / sponsor ID
- VCRTC2020-02
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Brien Holden Vision InstituteUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 24 Mar 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.
Myopia, considered as a global epidemic, is rapidly rising in prevalence especially in east Asian countries. Younger ages are associated with greater annual progression and thus early onset myopia is likely to result in higher levels of final net myopia.[1] Myopia, especially high myopia (more than -6.00D) is associated vision threatening complications such as cataract, glaucoma, choroidal thinning, vitreous liquefaction, myopic maculopathy, retinal detachment etc. Furthermore, myopia can affect the quality of life of an individual through restriction of employment in certain fields such as aviation. Myopia also imposes economic burden through the recurring cost of vision correction such as spectacles, contact lenses and specialist consultation fee. It is therefore important to develop novel optical and pharmaceutical strategies that can control or slow the progression of myopia.
Detailed description
To date, the strategies used to control or slow the progression of myopia are optical and pharmaceutical methods. Among spectacles, bifocal spectacles with and without prism, progressive addition lenses, spectacles altering peripheral hyperopic defocus, spectacles imposing myopic defocus both centrally and peripherally and spectacles with multiple defocus segments that imposes myopic defocus in front, midperiphery and periphery of the retina (defocus incorporating multiple segments or DIMS) are used to reduce the progression[2-6]. Of these, spectacles designed to alter peripheral defocus demonstrated a small treatment effect in reducing myopia progression[6, 7]. Bifocal and progressive addition spectacles demonstrated variable treatment effect in reducing progression of myopia. Among contact lenses, multifocal contact lenses altering peripheral defocus, extended depth of focus contact lenses altering higher order aberrations in order to degrade the retinal image behind the retina have shown promising results in slowing myopia progression along with orthokeratology treatment[8-12]. Among these, orthokeratology and multifocal soft contact lenses (centre distance multifocal contact lenses) showed promising results in slowing myopia progression[9, 12].
Pharmaceutical interventions include Atropine, Pirenzepine, 7-Methylxanthine and Timolol[13].Atropine is the most widely used, with higher concentrations more effective. Atropine 1% concentration demonstrated 60 to 80% reduction in progression of myopia. However, ocular side effects such as blurred vision, photophobia etc associated with atropine makes it a less appealing option. Among the various treatment approaches, spectacles pose the least or minimal side effects compared to contact lenses, orthokeratology or pharmaceutical strategies. Therefore, this study aims to determine the effect of novel myopia control prototype spectacle design on wearability and physiological ocular response among myopic children aged 7 to 14 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Vision Spectacles | Placebo comparator | Device: SpectaclesCommercially available conventional single vision spectacles |
| Commercially available myopia control spectacles | Active comparator | Device: SpectaclesCommercially available myopia control spectacles |
| Novel Myopia control spectacles - Prototype I | Experimental | Device: SpectaclesExperimental myopia control spectacles |
| Novel Myopia control spectacles - Prototype II | Experimental | Device: SpectaclesExperimental myopia control spectacles |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- be aged between 7 to 14 completed years (7 and 14 years inclusive), irrespective of gender.
- have cycloplegic autorefraction spherical component -0.50 D to - 4.50D, cylinder no more than -1.50D
- be accompanied by parents/guardians who can read and comprehend Vietnamese and give informed consent as demonstrated by signing a record of informed consent.
- be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
- have ocular health findings considered to be "normal".
Key exclusion criteria (11 listed)
- A known allergy to, or a history of intolerance to tropicamide or topical anaesthetics;
- Strabismus and/or amblyopia;
- Had previous eye surgery (including strabismus surgery);
- Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes;
- Had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids;
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 |
|---|---|---|
| SpectaclesNovel spectacles for myopia control | Device | Commercially available myopia control spectacles, Novel Myopia control spectacles - Prototype I, Novel Myopia control spectacles - Prototype II, Single Vision Spectacles |
Primary outcome
Change in axial length
Time frame: one monthly interval for up to 6 months
Change in axial length measured using Lenstar
1 secondary outcome
Vision and Choroidal Physiology
Time frame: One monthly interval for up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- 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.
Minh Huy Tran, M.D., Msc. principal investigator
Hai Yen Eye Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacles in people with Myopia, run by Brien Holden Vision Institute at 1 site in Vietnam.
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: status not confirmed, as of the sponsor's last update on 7 May 2021. 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 Vietnam. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minh Huy Tran, M.D., Msc. ((+84) 907 110 892, huy.tran@haiyeneyecare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in axial length (time frame: one monthly interval for up to 6 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 7 May 2021.