MyopiaPhase 1NCT00919334
Myopia Control With Simultaneous Vision Approach
A Phase 1 study testing Defocus Incorporated Soft Contact (DISC) lens in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach. 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?
- Defocus Incorporated Soft Contact (DISC) lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2007to Jun 2011
- Phase
- Phase 1
- 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 8-13 years
- Myopia (SE) between -1D to -5D
- Astigmatism less than or equal to -1D
- Anisometropia: less than or equal to 1.25D
- aided VA (monocular): 0.00 log MAR or better
- willingness to wear contact lens constantly
Show all 9Show fewer
- availability for follow-up for at least 2.5 years
- parents' understanding and acceptance
- willing to provide refractive status of grandparents
Who cannot join
- Severe ocular or systemic allergies
- Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
- Ocular or systemic condition that might affect refractive development
- Strabismus at distance or near
- Prior use of bifocal or progressive lenses
- Prior use of rigid gas permeable lenses and Ortho-K lenses
Trial locations and contacts
1 site in 1 country.
China1 site
Optometry Clinic, School of Optometry, The Hong Kong PolyU
Hong Kong
About this study
Official title: Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach
To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.
Read the detailed description
The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.
- Conditions
- Myopia
- Being tested
- Defocus Incorporated Soft Contact (DISC) lens
- Keywords
- Myopia progression, Myopia control, Simultaneous vision, Myopic defocus
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defocus Incorporated Soft Contact (DISC) lensDevice
Also called myopia control, myopia progression, Simultaneous vision, bifocal contact lens
Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia
| Study group | Role | What they receive |
|---|---|---|
| single vision soft contact lens | No intervention | Single vision soft contact lenses with same materials of the DISC lens |
| Defocus Incorporated Soft Contact (DISC) lens | Experimental | The use of DISC lens to slow down the progression of myopia Receives: Device: Defocus Incorporated Soft Contact (DISC) lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of cycloplegic refractive errors
Refractive error was measured using Shin-Nippon NVision-K 5001 autorefractor The changes of cycloplegic objective refractive errors between the treatment and the control were compared.
Measured: every 6 months for 2 years
Secondary outcomes (1)
The changes of axial length
Axial length was measured after cycloplegia using IOL Master
Measured: every 6 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJul 2007
- Primary completionJan 2011
- Study completionJun 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 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 PolyU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919334
- Sponsor's protocol ID
- GRF5438/06M
- Status last verified
- Jul 2014
- First submitted
- 11 Jun 2009
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lam CS, Tang WC, Tse DY, Tang YY, To CH. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial. Br J Ophthalmol. 2014 Jan;98(1):40-5. doi: 10.1136/bjophthalmol-2013-303914. Epub 2013 Oct 29.
PubMed 24169657Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
PubMed 36809645
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach
- ClinicalTrials.gov ID
- NCT00919334
- Acronym / sponsor ID
- GRF5438/06M
- Conditions
- Myopia
- Keywords
- Myopia progression, Myopia control, Simultaneous vision, Myopic defocus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 Jun 2009 (estimated)
- 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.
To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.
Detailed description
The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.
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 soft contact lenses with same materials of the DISC lens |
| Defocus Incorporated Soft Contact (DISC) lens | Experimental | Device: Defocus Incorporated Soft Contact (DISC) lensThe use of DISC lens to slow down the progression of myopia |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age 8-13 years
- Myopia (SE) between -1D to -5D
- Astigmatism less than or equal to -1D
- Anisometropia: less than or equal to 1.25D
- aided VA (monocular): 0.00 log MAR or better
Key exclusion criteria (6 listed)
- Severe ocular or systemic allergies
- Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
- Ocular or systemic condition that might affect refractive development
- Strabismus at distance or near
- Prior use of bifocal or progressive lenses
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 |
|---|---|---|
| Defocus Incorporated Soft Contact (DISC) lensAlso: myopia control, myopia progression, Simultaneous vision, bifocal contact lensUse of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia | Device | Defocus Incorporated Soft Contact (DISC) lens |
Primary outcome
The changes of cycloplegic refractive errors
Time frame: every 6 months for 2 years
Refractive error was measured using Shin-Nippon NVision-K 5001 autorefractor The changes of cycloplegic objective refractive errors between the treatment and the control were compared.
1 secondary outcome
The changes of axial length
Time frame: every 6 months for 2 years
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 3 Jul 2014.
- Results publication: PubMed 24169657Lam CS, Tang WC, Tse DY, Tang YY, To CH. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial. Br J Ophthalmol. 2014 Jan;98(1):40-5. doi: 10.1136/bjophthalmol-2013-303914. Epub 2013 Oct 29.
- Derived from this study: PubMed 36809645Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
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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 PolyU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Defocus Incorporated Soft Contact (DISC) lens 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 6 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 3 Jul 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The changes of cycloplegic refractive errors (time frame: every 6 months for 2 years). 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 NCT00919334, 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 3 Jul 2014; AzTrials last refreshed its copy on 27 Oct 2026.