MyopiaNCT03681366
Myopia Control Using Optimized Optical Defocus RCTs
A study testing DISC3.5 plus in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses. 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?
- DISC3.5 plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2018to 24 Jun 2022
- 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
- Age at enrolment: 8-13 year; Hong Kong Chinese
- Spherical equivalent refractions (SER): -1.00 to -5.00D
- Astigmatism: -1.00D or less
- Anisometropia: 1.25D or less
- Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
- Contact lens corrected monocular VA: 0.1 logMAR or better
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- Normal binocular function
- Willingness to wear contact lenses regularly
- Parents' understanding and acceptance of random allocation of grouping and masking
Who cannot join
- Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
- Strabismus or decompensated phoria (checked by cover test at far and near in screening)
- Known contraindications for contact lens wear
- Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development
Trial locations and contacts
1 site in 1 country.
China1 site
The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU
Hong Kong
About this study
Official title: Myopia Control Using Optimized Optical Defocus in Schoolchildren - a Randomized Double Masked Control Trial
The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.
Read the detailed description
The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.
The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.
- Conditions
- Myopia
- Being tested
- DISC3.5 plus
- Keywords
- myopia, Myopic Defocus, contact lens, myopia control
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISC3.5 plusDevice
The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
| Study group | Role | What they receive |
|---|---|---|
| Single vision soft contact lens | No intervention | single vision, spherical soft contact lens |
| DISC3.5 Plus lens | Experimental | A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas. Receives: Device: DISC3.5 plus |
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 autorefraction in spherical equivalent (SER)
Measured: 12 months
Secondary outcomes (1)
Axial length
Axial length (mm) was measured after cycloplegia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start25 Oct 2018
- Primary completion8 May 2021
- Study completion24 Jun 2022
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly Lam, The Hong Kong Polytechnic University
- Investigators
- Carly SY Lam, phD, Principal investigator, School of Optometry, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681366
- Sponsor's protocol ID
- HSEARS20180711001
- Status last verified
- Aug 2022
- First submitted
- 20 Sep 2018
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Control Using Optimized Optical Defocus in Schoolchildren - a Randomized Double Masked Control Trial
- ClinicalTrials.gov ID
- NCT03681366
- Acronym / sponsor ID
- HSEARS20180711001
- Conditions
- Myopia
- Keywords
- myopia, Myopic Defocus, contact lens, myopia control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 8 May 2021 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 24 Sep 2018 (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.
The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.
Detailed description
The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.
The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single vision soft contact lens | No intervention | –single vision, spherical soft contact lens |
| DISC3.5 Plus lens | Experimental | Device: DISC3.5 plusA soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age at enrolment: 8-13 year; Hong Kong Chinese
- Spherical equivalent refractions (SER): -1.00 to -5.00D
- Astigmatism: -1.00D or less
- Anisometropia: 1.25D or less
- Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
Key exclusion criteria (4 listed)
- Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
- Strabismus or decompensated phoria (checked by cover test at far and near in screening)
- Known contraindications for contact lens wear
- Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development
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 |
|---|---|---|
| DISC3.5 plusThe Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas. | Device | DISC3.5 Plus lens |
Primary outcome
Cycloplegic Refraction Change in SER
Time frame: 12 months
Change in cycloplegic autorefraction in spherical equivalent (SER)
1 secondary outcome
Axial length
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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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
School of Optometry, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DISC3.5 plus in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in China.
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 9 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: finished, as of the sponsor's last update on 24 Aug 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 12 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 24 Aug 2022.