MyopiaNCT04048148
Myopia Progression Trial With Novel Myopia Control Design Spectacle Lenses
A study of Myopia, run by Brien Holden Vision Institute at 1 site in Vietnam.
Trial summary
This is a mono-center, randomized, double-masked, cross-over study to evaluate rate of myopia progression with novel designed myopia control lens (test) compared to SVL (control). Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteVietnam
- Study dates
- 31 May 2019to 31 May 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- General inclusion criterion:
- Volunteer subject and guardian, fluent Vietnamese spoken, willing to follow the protocol and able to read, comprehend and sign the informed consent form.
- Study related inclusion criteria:
- Age: equal to or greater than 8 years and not older than 13 years.
- Spherical refractive error of -0.75 to -4.75 D in each eye (spherical equivalent), as measured by cycloplegic autorefraction.
- Astigmatism of not more than 1.50 D.
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- Anisometropia of not more than 1.00 D.
- Best corrected visual acuity of equal or better than 0.05 LogMAR
- No strabismus by cover test at near and distance.
- Have the ability to comply with the protocol to get the reliable study measurements.
- Absence of ocular disease with full ophthalmic examination, such as retinal disease, cataract and ptosis. Good general health, without systemic or neurodevelopmental conditions. Without ocular or systemic medicine, which might affect myopia progression or visual acuity through known effects on retina, accommodation or significant elevation of intraocular pressure.
- No history of progressive addition lenses (PALs) or bifocal use and no prior use of contact lenses
Who cannot join
- General exclusion criteria:
- Vulnerability of the subject,
- Participation in another study which might have an influence on vision or interfere with study assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-masked, Randomized, Cross-over Comparative Study of Novel Myopia Control Designed Lens (Test Lens) Versus Single Vision Lens (SVL; Control)
This is a mono-center, randomized, double-masked, cross-over study to evaluate rate of myopia progression with novel designed myopia control lens (test) compared to SVL (control). A total of 120 children will be recruited where 60 participants each will be randomized either to wear test (Group 1) or SVL lenses (Group 2) for 6 months each. At the end of the 6 months period, there will be a cross- over of lenses and the lenses evaluated for a further 6 months. At the end of the 12 month period, all participants (Group 1 and Group 2) will wear test lenses for another 6 months.
Read the detailed description
Myopia has been considered as a 'global epidemic' owing to its rapid rise in prevalence across the world. Myopia significantly affects the quality of life of an individual socially by restriction of employment in various fields and economically by additional cost for eye care and spectacles and contact lenses (Lim, Gazzard et al. 2009). In addition, high myopia increases the risk of ocular morbidity such as retinal detachment, cataract, glaucoma which can could lead to blindness. Several optical and pharmaceutical strategies were developed over the recent years that could control or slow the progression of myopia.
It has been shown that persistent myopic defocus constantly applied on the whole retina has a beneficial effect on myopia progression, i.e. decrease in myopia progression (Anstice and Phillips 2011, Cheng, Woo et al. 2011, Ehsaei, Chisholm et al. 2011). In addition, a meta-analysis on the efficacy of non-invasive optical treatment strategies for myopia control reported prismatic bifocals to have the best outcome (Cheng, Woo et al. 2011). Therefore, test lenses were designed to increase the area and amount of myopic defocus on the retina without compromising vision.
Thus, this study aims to evaluate the efficacy of test lenses to reduce the progression of myopia by either reducing the myopia progression rate per year and/or reducing the elongation of eyeball through myopic defocus compared with SVL. A total of 120 healthy children aged 8 to 13 years will be recruited to participate in a double-masked cross-over clinical trial. Cycloplegic autorefraction will be the primary measure for myopia progression and axial length will the secondary outcome measure. Visual acuity will also be compared between test lens and control lens to determine the quality of vision using test lens.
- Conditions
- Myopia
- Being tested
- Novel designed 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.
Novel designed myopia control spectacle lensesDevice
A novel designed myopia control spectacle lenses (test lenses) will be given to both arms to wear for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Novel myopia control lenses | Other | This group will be randomized to wear test lenses for 6 months followed by control lenses for 6 months and then test lenses for another 6 months Receives: Device: Novel designed myopia control spectacle lenses |
| Single vision lenses | Other | This group will be randomized to wear control lenses for 6 months followed by test lenses for 12 months Receives: Device: Novel designed myopia control spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic refraction
Change in myopia progression measured by cycloplegic refraction (Diopters) using Shin Nippon Auto-refractor
Measured: Up to 18 months
Secondary outcomes (1)
Axial length
Change in ocular axial length (mm) measured using Lenstar Optical Biometer
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start31 May 2019
- Primary completion30 Apr 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Crossover
- Model description
- This is a mono-center, randomized, double-masked, cross-over study to evaluate if novel design lens can slow down the progression of myopia. A total of 120 healthy children aged between 8 years to 13 years with myopia (-0.75D to -4.75D) meeting the inclusion and exclusion criteria will be recruited. These children will be randomized to wear test lenses followed by control lenses (Group 1) or to wear control lenses followed by test lenses (Group 2). At the end of the 12 month period, all participants will wear test lenses for another 6 months. All children will be followed at 3-monthly intervals for 1.5 years to monitor for changes in axial length and 6-monthly for changes in cycloplegic autorefraction. The cross-over design allows to compare treatment effects between the two groups at 6 months, 12 months and at 18 months. In addition, at the end of the study, the treatment effects can be compared within subject as each subject will have worn both lenses and serves as his/her control.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brien Holden Vision Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Essilor International, Hai Yen Eye Care
- Responsible party
- Principal investigator, Rebecca Weng, Brien Holden Vision Institute
- Investigators
- Padmaja Sankaridurg, PhD, Study director, Brien Holden Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048148
- Sponsor's protocol ID
- VCRTC2019-01
- Status last verified
- Jan 2021
- First submitted
- 4 Aug 2019
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical study report will be shared once the study is completed. Study anticipate to be completed in 2020.
Publications
Sankaridurg P, Weng R, Tran H, Spiegel DP, Drobe B, Ha T, Tran YH, Naduvilath T. Spectacle Lenses With Highly Aspherical Lenslets for Slowing Myopia: A Randomized, Double-Blind, Cross-Over Clinical Trial: Parts of these data were presented as a poster at the Annual Research in Vision and Ophthalmology meeting, 2022. Am J Ophthalmol. 2023 Mar;247:18-24. doi: 10.1016/j.ajo.2022.10.021. Epub 2022 Nov 5.
PubMed 36347276
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Randomized, Cross-over Comparative Study of Novel Myopia Control Designed Lens (Test Lens) Versus Single Vision Lens (SVL; Control)
- ClinicalTrials.gov ID
- NCT04048148
- Acronym / sponsor ID
- VCRTC2019-01
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Brien Holden Vision InstituteUniversity, hospital or other
- Collaborators
- Essilor International, Hai Yen Eye Care
- Study start
- 31 May 2019 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 7 Aug 2019 (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 is a mono-center, randomized, double-masked, cross-over study to evaluate rate of myopia progression with novel designed myopia control lens (test) compared to SVL (control). A total of 120 children will be recruited where 60 participants each will be randomized either to wear test (Group 1) or SVL lenses (Group 2) for 6 months each. At the end of the 6 months period, there will be a cross- over of lenses and the lenses evaluated for a further 6 months. At the end of the 12 month period, all participants (Group 1 and Group 2) will wear test lenses for another 6 months.
Detailed description
Myopia has been considered as a 'global epidemic' owing to its rapid rise in prevalence across the world. Myopia significantly affects the quality of life of an individual socially by restriction of employment in various fields and economically by additional cost for eye care and spectacles and contact lenses (Lim, Gazzard et al. 2009). In addition, high myopia increases the risk of ocular morbidity such as retinal detachment, cataract, glaucoma which can could lead to blindness. Several optical and pharmaceutical strategies were developed over the recent years that could control or slow the progression of myopia.
It has been shown that persistent myopic defocus constantly applied on the whole retina has a beneficial effect on myopia progression, i.e. decrease in myopia progression (Anstice and Phillips 2011, Cheng, Woo et al. 2011, Ehsaei, Chisholm et al. 2011). In addition, a meta-analysis on the efficacy of non-invasive optical treatment strategies for myopia control reported prismatic bifocals to have the best outcome (Cheng, Woo et al. 2011). Therefore, test lenses were designed to increase the area and amount of myopic defocus on the retina without compromising vision.
Thus, this study aims to evaluate the efficacy of test lenses to reduce the progression of myopia by either reducing the myopia progression rate per year and/or reducing the elongation of eyeball through myopic defocus compared with SVL. A total of 120 healthy children aged 8 to 13 years will be recruited to participate in a double-masked cross-over clinical trial. Cycloplegic autorefraction will be the primary measure for myopia progression and axial length will the secondary outcome measure. Visual acuity will also be compared between test lens and control lens to determine the quality of vision using test lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a mono-center, randomized, double-masked, cross-over study to evaluate if novel design lens can slow down the progression of myopia. A total of 120 healthy children aged between 8 years to 13 years with myopia (-0.75D to -4.75D) meeting the inclusion and exclusion criteria will be recruited. These children will be randomized to wear test lenses followed by control lenses (Group 1) or to wear control lenses followed by test lenses (Group 2). At the end of the 12 month period, all participants will wear test lenses for another 6 months. All children will be followed at 3-monthly intervals for 1.5 years to monitor for changes in axial length and 6-monthly for changes in cycloplegic autorefraction. The cross-over design allows to compare treatment effects between the two groups at 6 months, 12 months and at 18 months. In addition, at the end of the study, the treatment effects can be compared within subject as each subject will have worn both lenses and serves as his/her control.
| Arm | Type | Receives |
|---|---|---|
| Novel myopia control lenses | Other | Device: Novel designed myopia control spectacle lensesThis group will be randomized to wear test lenses for 6 months followed by control lenses for 6 months and then test lenses for another 6 months |
| Single vision lenses | Other | Device: Novel designed myopia control spectacle lensesThis group will be randomized to wear control lenses for 6 months followed by test lenses for 12 months |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Volunteer subject and guardian, fluent Vietnamese spoken, willing to follow the protocol and able to read, comprehend and sign the informed consent form.
- Age: equal to or greater than 8 years and not older than 13 years.
- Spherical refractive error of -0.75 to -4.75 D in each eye (spherical equivalent), as measured by cycloplegic autorefraction.
- Astigmatism of not more than 1.50 D.
- Anisometropia of not more than 1.00 D.
Key exclusion criteria (3 listed)
- Vulnerability of the subject,
- Participation in another study which might have an influence on vision or interfere with study assessments.
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 |
|---|---|---|
| Novel designed myopia control spectacle lensesA novel designed myopia control spectacle lenses (test lenses) will be given to both arms to wear for 12 months. | Device | Novel myopia control lenses, Single vision lenses |
Primary outcome
Cycloplegic refraction
Time frame: Up to 18 months
Change in myopia progression measured by cycloplegic refraction (Diopters) using Shin Nippon Auto-refractor
1 secondary outcome
Axial length
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Derived from this study: PubMed 36347276Sankaridurg P, Weng R, Tran H, Spiegel DP, Drobe B, Ha T, Tran YH, Naduvilath T. Spectacle Lenses With Highly Aspherical Lenslets for Slowing Myopia: A Randomized, Double-Blind, Cross-Over Clinical Trial: Parts of these data were presented as a poster at the Annual Research in Vision and Ophthalmology meeting, 2022. Am J Ophthalmol. 2023 Mar;247:18-24. doi: 10.1016/j.ajo.2022.10.021. Epub 2022 Nov 5.
- Individual participant dataSharing planned: Yes. Clinical study report will be shared once the study is completed. Study anticipate to be completed in 2020.
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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.
Padmaja Sankaridurg, PhD study director
Brien Holden Vision Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 12 inclusion and 3 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 28 Jan 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. 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?
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 (time frame: Up to 18 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 NCT04048148, which also lists 1 linked publication.
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 28 Jan 2021.