MyopiaNCT02643758
Myopia Control Using Soft Bifocal Lenses
A study testing Bifocal soft contact lenses in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The purpose of this study is to evaluate whether bifocal soft contact lenses (CLs) with low addition and nasally decentered optical zone are effective in controlling myopic progression in children. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Bifocal soft contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Jan 2016to 30 Sep 2018
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Refractive sphere: -0.75 D to -4.50 D
- Refractive cylinder: not exceed 1.00 D
- Spherical equivalent: -0.75 D to -5.00 D
- Best corrected distance VA (LogMAR): 0.14 or better in each eye and 0.10 or better in both eyes
- Difference in refractive error (spherical equivalent) in the two eyes: not exceed 1.00 D
Who cannot join
- Prior history of myopia control treatment
- Contraindication to contact lens wear
- Binocular anomalies (e.g. strabismus)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Optometry, The Hong Kong Polytechnic University
Kowloon
About this study
Official title: Randomised Clinical Trial: Myopia Control Using Soft Bifocal Lenses
The purpose of this study is to evaluate whether bifocal soft contact lenses (CLs) with low addition and nasally decentered optical zone are effective in controlling myopic progression in children. Visual manipulations induced by multifocal soft CLs with high addition have been shown to inhibit eye growth and myopia development in children by recent studies. Several theories have been proposed including alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations. However, those theories remain to be proven and the optical properties and performance of multifocal soft CLs have not been investigated in children.
Read the detailed description
Visual manipulations induced by multifocal soft contact lenses (CLs) with high addition (+2.00 D or above) have been shown to inhibit eye growth and myopia development in children with up to 25-50% efficacy by recent studies. Several theories have been proposed including; alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations, which remain to be proven. However, the effect of controlling myopic progression by bifocal CLs with low addition has not been studied.
Several studies have shown that multifocal soft CLs can induce changes in ocular aberrations and degradation of image qualities in adults, whereas the optical properties and performance of multifocal soft CLs have not been investigated in children. Due to the differences in ocular structure and function, for instance, the pupil size and accommodation response, the performance of multifocal CLs in children may vary compared with that in adults. As a result, it is essential to assess the optical quality of these lenses worn by children for myopia control, through COAS (Complete Ophthalmic Analysis System).
The aim of this randomized clinical trial is to evaluate myopic progression in children wearing soft bifocal with low addition CLs (Menicon 2 week Duo **) used as daily disposable lenses, compared to control subjects wearing single-vision spectacles. Myopia progression quantified by changes in axial length (AL) and cycloplegic refractive error (Rx) will be monitored for 2 years with single-masking. The optical performance of bifocal CLs worn by children will also be investigated.
(**this lens is currently commercially available in Japan only. The oxygen permeability (Dk) is 34 with 72% water content, FDA group Ⅱ.)
- Conditions
- Myopia
- Being tested
- Bifocal soft contact lenses
- Keywords
- Myopia control, bifocal soft contact lenses, children
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifocal soft contact lensesDevice
Also called Menicon Duo 2 week soft bifocal lenses
| Study group | Role | What they receive |
|---|---|---|
| Bifocal soft contact lenses | Experimental | Device: Bifocal soft contact lenses Use of bifocal contact lenses with nasally decentered optical zone to control the progression of myopia Receives: Device: Bifocal soft contact lenses |
| Single vision spectacles | No intervention | Control: Single vision spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in axial length in 2 years
Evaluate the changes in cycloplegic axial length in children wearing bifocal soft contact lenses with low addition used as daily disposable lenses compared to control subjects wearing single-vision spectacles for two years with single masking and randomisation
Measured: Every 6 months for a period of 2 years
Changes in cycloplegic refractive error in 2 years
Evaluate the changes in cycloplegic refractive error in children wearing bifocal soft contact lenses with low addition used as daily disposable lenses compared to control subjects wearing single-vision spectacles for two years with single masking and randomisation
Measured: Every 6 months for a period of 2 years
Secondary outcomes (3)
Changes in wavefront aberrations in 2 years
Assess changes in aberration profile by COAS (Complete Ophthalmic Analysis System) over a period of 2 years
Measured: Every 6 months for a period of 2 years
Changes in accommodation responses in 2 years
Assess changes in the accommodation responses of children over a period of two years
Measured: Every 6 months for a period of 2 years
Changes in wavefront aberrations of children with bifocal soft contact lenses in 2 years
Assess the aberration profile of children wearing bifocal soft contact lenses by COAS (Complete Ophthalmic Analysis System) over a period of 2 years
Measured: Every 6 months for a period of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study start25 Jan 2016
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Why it stopped: A corporate decision to terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Menicon Co., Ltd., Queensland University of Technology
- Responsible party
- Principal investigator, Pauline Cho, The Hong Kong Polytechnic University
- Investigators
- Pauline Cho, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643758
- Sponsor's protocol ID
- HSEARS20151016008
- Status last verified
- Feb 2019
- First submitted
- 8 Dec 2015
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26.
PubMed 21276616Fujikado T, Ninomiya S, Kobayashi T, Suzaki A, Nakada M, Nishida K. Effect of low-addition soft contact lenses with decentered optical design on myopia progression in children: a pilot study. Clin Ophthalmol. 2014 Sep 23;8:1947-56. doi: 10.2147/OPTH.S66884. eCollection 2014.
PubMed 25284981Lam 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 24169657Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260.
PubMed 22039230Walline JJ, Greiner KL, McVey ME, Jones-Jordan LA. Multifocal contact lens myopia control. Optom Vis Sci. 2013 Nov;90(11):1207-14. doi: 10.1097/OPX.0000000000000036.
PubMed 24061152Gifford P, Cannon T, Lee C, Lee D, Lee HF, Swarbrick HA. Ocular aberrations and visual function with multifocal versus single vision soft contact lenses. Cont Lens Anterior Eye. 2013 Apr;36(2):66-73; quiz 103-4. doi: 10.1016/j.clae.2012.10.078. Epub 2012 Nov 10.
PubMed 23146418Llorente-Guillemot A, Garcia-Lazaro S, Ferrer-Blasco T, Perez-Cambrodi RJ, Cervino A. Visual performance with simultaneous vision multifocal contact lenses. Clin Exp Optom. 2012 Jan;95(1):54-9. doi: 10.1111/j.1444-0938.2011.00666.x. Epub 2011 Nov 10.
PubMed 22070196
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial: Myopia Control Using Soft Bifocal Lenses
- ClinicalTrials.gov ID
- NCT02643758
- Acronym / sponsor ID
- HSEARS20151016008
- Conditions
- Myopia
- Keywords
- Myopia control, bifocal soft contact lenses, children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A corporate decision to terminate the study
- Enrolment
- 97 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Menicon Co., Ltd., Queensland University of Technology
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 31 Dec 2015 (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.
The purpose of this study is to evaluate whether bifocal soft contact lenses (CLs) with low addition and nasally decentered optical zone are effective in controlling myopic progression in children. Visual manipulations induced by multifocal soft CLs with high addition have been shown to inhibit eye growth and myopia development in children by recent studies. Several theories have been proposed including alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations. However, those theories remain to be proven and the optical properties and performance of multifocal soft CLs have not been investigated in children.
Detailed description
Visual manipulations induced by multifocal soft contact lenses (CLs) with high addition (+2.00 D or above) have been shown to inhibit eye growth and myopia development in children with up to 25-50% efficacy by recent studies. Several theories have been proposed including; alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations, which remain to be proven. However, the effect of controlling myopic progression by bifocal CLs with low addition has not been studied.
Several studies have shown that multifocal soft CLs can induce changes in ocular aberrations and degradation of image qualities in adults, whereas the optical properties and performance of multifocal soft CLs have not been investigated in children. Due to the differences in ocular structure and function, for instance, the pupil size and accommodation response, the performance of multifocal CLs in children may vary compared with that in adults. As a result, it is essential to assess the optical quality of these lenses worn by children for myopia control, through COAS (Complete Ophthalmic Analysis System).
The aim of this randomized clinical trial is to evaluate myopic progression in children wearing soft bifocal with low addition CLs (Menicon 2 week Duo **) used as daily disposable lenses, compared to control subjects wearing single-vision spectacles. Myopia progression quantified by changes in axial length (AL) and cycloplegic refractive error (Rx) will be monitored for 2 years with single-masking. The optical performance of bifocal CLs worn by children will also be investigated.
(**this lens is currently commercially available in Japan only. The oxygen permeability (Dk) is 34 with 72% water content, FDA group Ⅱ.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifocal soft contact lenses | Experimental | Device: Bifocal soft contact lensesDevice: Bifocal soft contact lenses Use of bifocal contact lenses with nasally decentered optical zone to control the progression of myopia |
| Single vision spectacles | No intervention | –Control: Single vision spectacles |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Refractive sphere: -0.75 D to -4.50 D
- Refractive cylinder: not exceed 1.00 D
- Spherical equivalent: -0.75 D to -5.00 D
- Best corrected distance VA (LogMAR): 0.14 or better in each eye and 0.10 or better in both eyes
- Difference in refractive error (spherical equivalent) in the two eyes: not exceed 1.00 D
Key exclusion criteria (3 listed)
- Prior history of myopia control treatment
- Contraindication to contact lens wear
- Binocular anomalies (e.g. strabismus)
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 |
|---|---|---|
| Bifocal soft contact lensesAlso: Menicon Duo 2 week soft bifocal lenses | Device | Bifocal soft contact lenses |
Primary outcome
Changes in axial length in 2 years
Time frame: Every 6 months for a period of 2 years
Evaluate the changes in cycloplegic axial length in children wearing bifocal soft contact lenses with low addition used as daily disposable lenses compared to control subjects wearing single-vision spectacles for two years with single masking and randomisation
Changes in cycloplegic refractive error in 2 years
Time frame: Every 6 months for a period of 2 years
Evaluate the changes in cycloplegic refractive error in children wearing bifocal soft contact lenses with low addition used as daily disposable lenses compared to control subjects wearing single-vision spectacles for two years with single masking and randomisation
3 secondary outcomes
Changes in wavefront aberrations in 2 years
Time frame: Every 6 months for a period of 2 years
Changes in accommodation responses in 2 years
Time frame: Every 6 months for a period of 2 years
Changes in wavefront aberrations of children with bifocal soft contact lenses in 2 years
Time frame: Every 6 months for a period of 2 years
Results and safety
The study was stopped early (reason given: A corporate decision to terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Background: PubMed 21276616Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26.
- Background: PubMed 25284981Fujikado T, Ninomiya S, Kobayashi T, Suzaki A, Nakada M, Nishida K. Effect of low-addition soft contact lenses with decentered optical design on myopia progression in children: a pilot study. Clin Ophthalmol. 2014 Sep 23;8:1947-56. doi: 10.2147/OPTH.S66884. eCollection 2014.
- Background: 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.
- Background: PubMed 22039230Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260.
- Background: PubMed 24061152Walline JJ, Greiner KL, McVey ME, Jones-Jordan LA. Multifocal contact lens myopia control. Optom Vis Sci. 2013 Nov;90(11):1207-14. doi: 10.1097/OPX.0000000000000036.
- Background: PubMed 23146418Gifford P, Cannon T, Lee C, Lee D, Lee HF, Swarbrick HA. Ocular aberrations and visual function with multifocal versus single vision soft contact lenses. Cont Lens Anterior Eye. 2013 Apr;36(2):66-73; quiz 103-4. doi: 10.1016/j.clae.2012.10.078. Epub 2012 Nov 10.
- Background: PubMed 22070196Llorente-Guillemot A, Garcia-Lazaro S, Ferrer-Blasco T, Perez-Cambrodi RJ, Cervino A. Visual performance with simultaneous vision multifocal contact lenses. Clin Exp Optom. 2012 Jan;95(1):54-9. doi: 10.1111/j.1444-0938.2011.00666.x. Epub 2011 Nov 10.
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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.
Pauline Cho, PhD principal investigator
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 Bifocal soft contact lenses 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 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: stopped early, as of the sponsor's last update on 25 Feb 2019. 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?
The study was stopped early (reason given: A corporate decision to terminate the 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?
Changes in axial length in 2 years (time frame: Every 6 months for a period of 2 years). The study lists 2 primary outcomes in all. 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 NCT02643758, which also lists 7 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 25 Feb 2019.