MyopiaNCT03246464
Clinical Study Of Nearsightedness; TReatment With Orthokeratology Lenses (CONTROL)
A study testing Orthokeratology lenses and Single-vision spectacles in people with Myopia, run by Vejle Hospital at 1 site in Denmark.
Trial summary
Myopia is a common disease of the eye with increasing prevalence in the Western World as well as in South East Asia where 60-90% of the children are affected. High myopia is associated with an increasing risk of sight threatening complications such as retinal detachment, glaucoma, macular choroidal degeneration and… 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?
- Orthokeratology lenses and Single-vision spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to 17 Apr 2020
- 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
- Myopia -0.5 to -4.75 dioptries spherical in one or both eyes.
- Regular astigmatism ≤ -2.5 diopters in one or both eyes.
- Age 6 ≥ 12 years.
- Anisometropia < 1.5 D spherical equivalent.
- Best corrected visual acuity of 0.1 logMAR or better in both eyes.
- Acceptance of treatment randomization.
Who cannot join
- Manifest or latent squint.
- Contraindications to the use of OKL comprising keratoconus, allergic conjunctivitis and keratoconjunctivitis sicca.
- Previous eye surgery.
- Chronic eye disease demanding daily use of eye drops.
- Non-compliance to eye examinations (unstable fixation or intolerance to OKL).
- One or both parents being ethnical Asian, African, Hispanic or Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orthokeratology Contact Lenses for the Treatment of Myopia in a Group of Danish Children
Myopia is a common disease of the eye with increasing prevalence in the Western World as well as in South East Asia where 60-90% of the children are affected. High myopia is associated with an increasing risk of sight threatening complications such as retinal detachment, glaucoma, macular choroidal degeneration and myopic choroidal neovascularization. In myopia the eye is elongated compared to an emmetropic eye. If the elongation of the eye can be controlled the progression of myopia can be controlled. Asian studies have shown reduction in axial length growth by 36-46% in children using orthokeratology contact lenses (OKL). OKL are custom fit, form stable lenses. During sleep the cornea is reshaped creating an emmetropic vision during the day, so no glasses or contact lenses are needed. Twin and family studies have shown a high heritability for the development of myopia, and more than 40 genetic loci have been identified indicating that the effect of OKL in Asian children might not be the same in North European children which is why we want to execute a similar study on North European children.
Purpose:
Read more
- Investigate if nightly wear of OKL reduces the progression of childhood myopia (change in axial length) in Danish children when compared to a control group using monofocal glasses.
- Investigate the safety (Efron score) of OKL.
- Investigate children's quality of life impact of refractive correction (questionnaire) using OKL compared to glasses.
- Identify possible predictors for progression of myopia (AC/A ratio, peripheral defocus and higher order aberrations).
Method:
A randomized controlled 18 months prospective 1:1 study of a group of Danish children. 60 children will be included; 30 in each group. The participants will undergo several measurements reflecting the anatomy and function of the eye at baseline, 6, 12 and 18 month to evaluate the effect.
Read the detailed description
Myopia is a common disease of the eye with increasing prevalence in the Western World as well as in South East Asia where 60-90% of the children are affected. A Danish study found that early debut of myopia is associated with a higher degree of myopia later on in life. Myopia may be corrected with spectacles, contact lenses or surgically, but despite this socio-economic burden, high myopia is associated with an increasing risk of sight threatening complications such as retinal detachment, glaucoma, macular choroidal degeneration and myopic choroidal neovascularization.
Myopia is a complex disease with a multi-factorial etiology. Twin studies and family studies have shown a high heritability for development of myopia, and more than 40 genetic loci have been identified. Outdoor activity seems to reduce the myopia progression. The shape of the eye may be of importance; axial growth makes the eye ellipsoidal which increase the peripheral defocus on the retina. Peripheral defocus has been suggested to induce further axial growth of the eyeball.
Accommodation is a significant covariant of near work and reading. A cross section study has shown a reduced precision in accommodation (A) on a near object combined with increased convergence (C) in myopic eyes. This increased AC/A ratio (dynamic) may be a predictor for myopia progression.
Interventions for reducing myopia progression have been many. The effects of progressive additional lenses, multifocal lenses and bifocal lenses have been limited. Anticholinergic eyedrops (Atropin 0.01%) significantly reduce the progression of myopia in Asian children by approximately 50% over a period of two years with limited side effects. Almost similar results have been found in Asian children using orthokeratology contact lenses (OKL) for reducing myopia progression.
OKL are custom fit, form stable lenses used during sleep. The lenses induce a temporal flattening of the cornea, which modify or eliminate refractive errors, leaving no need for glasses or contact lenses during daytime. OKL were introduced in the 1960 ́s, but with limited success due the lens material (PMMA) which was not gas-permeable. Decentration was also a problem making the effect variable and unpredictable. With new gas- permeable lens materials and computer assisted topographic measurements of the cornea, fitting of the lenses has been improved significantly, so that nightly wear is now standard treatment.
A clear-cut reduction in axial length growth in Asian children using OKL compared to single-vision spectacles (SVS) has been proofed in several studies. In these studies, which are very heterogeneous regarding design, reductions of 36-46% in axial length growth were found compared to a matched control group. Two European prospective cohort studies have investigated the effect of OKL compared to SVS in Spanish children. A reduction in axial growth of 32 % and 38% respectively was found. Side effects of OKL have been evaluated; in a meta-analysis from 2015, including 8 Asian and one of the European studies. Odds Ratio for side effects were 8.87 for the OK group compared to the control group, however all side effects were mild and disappeared after termination of the treatment.
Thus, a reduction in childhood myopia using OKL has been proofed in Asian children; however, weather similar result can be achieved in a group of children from Northern Europe is unknown. The influence of OKL on quality of life impact of refractive correction has never been investigated in a randomized trail. How OKL reduce the axial growth of the eye is unknown. The lenses induce multifocality and higher order aberrations in the cornea, which might change the peripheral defocus. A change in defocus has been suggested as a mechanism for controlling axial length growth.
Primary goals:
In a randomized 18 months prospective 1:1 study of a group of Danish children to:
- Investigate if nightly wear of OKL (DreamliteR, Procornea, Nederlands) may reduce the progression of childhood myopia (change in axial length) when compared to a control group using SVS.
- Investigate safety (Efron score) in the use of OKL.
- Compare children's quality of life impact of refractive correction (questionnaire) using OKL and glasses.
- Identify possible predictors for progression of myopia (AC/A ratio, peripheral defocus and higher order aberrations).
Hypothesis:
- Nightly wear of OKL reduces the progression of childhood myopia in Danish children.
- Use of OKL is safe, with no sight threatening complications during 18 months of nightly treatment.
- Children using OKL experience a higher quality of life impact of refractive correction compared to children wearing SVS.
- Response AC/A ratio is positively correlated to progression of childhood myopia.
- Use of OKL induce changes in corneal topography resulting in (1) decreased peripheral defocus (2) increased number of higher order aberrations. Progression in childhood myopia is associated to changes in peripheral defocus and higher order aberrations.
Design:
A 18-month randomized prospective 1:1 study of progression of myopia in a group of Danish children wearing OKL nightly (n=30) compared to a control group wearing SVS (n=30).
Children randomized to OKL will be examined at BL and day 3 and 7 as well as month 1, 3, 6, 9, 12, 15, and 18 after the start of treatment with OKL (T0).
Children randomized to SVS will be examined at BL and month 6, 12 and 18 after receiving new glasses with optimal prescription (T0).
Examination:
- Best corrected (using "push plus" refraction principle) ETDRS visual acuity: The OKL group (2-4 hours after lens removal) at BL and day 3 and 7 as well as month 1, 3, 6, 9, 12, 15, and 18 after T0. The SVS group at BL and month 6, 12 and 18 after T0.
- Grading contact lens complications (Efron Grading Scale for Contact Lens Complications) for the OKL group at day 3 and 7 as well as month 1, 3, 6, 9,12, 15, and 18 after T0.
- Dynamic auto-refraction (Shin-Nippon SRW-5000, Kagawa, Japan) for both groups at a distance of 40 cm in primary gaze as well as 5, 10, 20 and 30 degrees eccentric to the nasal and temporal retina in the horizontal meridian at BL and month 6, 12 and 18 after T0.
- Measurements of convergence for both groups at a distance of 40 cm and 6 meter using the Eye-Link 1000 (SR Research, Ontario, Canada) at BL and month 6, 12 and 18 after T0.
- Cycloplegic auto-refraction at BL, 6, 12, and 18 months (Topcon KR-800, Topcon Europe Medical, Capelle aan den Ijss, Nederlands).
- Axial length measurements (Lensstar, LS900, Carl Zeiss, Haag-Streit, Koeniz, Switzerland) at BL, 6, 12 and 18 months after T0 for both patients groups.
- Pentacam (Oculus, Wetzlar, Germany) for the OKL group at BL, T0, day 3, 7 as well as month 1, 3, 6, 9, 12, 15, and 18 after T0 (measurements obtained 2-4 hours after lens removal). For the group wearing SVS at BL, and month 6, 12 and 18 after T0.
- Pediatric Refractive Error Profile 2 (questionnaire) will be performed at 12 month for both patient groups.
- Conditions
- Myopia
- Being tested
- Orthokeratology lenses, Single-vision spectacles
- Keywords
- Contact lenses, Children, Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthokeratology lensesDevice
Rigid gas permeable contact lenses
Single-vision spectaclesDevice
Regular single vision spectacles
| Study group | Role | What they receive |
|---|---|---|
| Single-vision spectacles | Placebo comparator | Not described Receives: Device: Single-vision spectacles |
| Orthokeratology lenses | Active comparator | Not described Receives: Device: Orthokeratology lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of myopia defined as change in axial length 18 months after start of intervention
Measured: Follow up to 18 months
Secondary outcomes (3)
Quality of life comparison between myopic children wearing glasses and orthokeratology lenses using the Pediatric Refractive Error Profile 2 Questionnaire
Measured: Follow up to 18 months
Safety evaluation by Efron scores for orthokeratology lenses
Measured: Follow up to 18 months
Accommodation and higher-order aberrations
Median change in dynamic AC/A ratio and higher-order aberrations from BL to 18 months in myopic children wearing orthokeratology lenses and single-vision glasses
Measured: Follow 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 posted11 Aug 2017
- Study start1 Mar 2017
- Primary completion17 Apr 2020
- Study completion17 Apr 2020
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controled clinical interventional trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ens Eyes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246464
- Sponsor's protocol ID
- CONTROL
- Status last verified
- May 2020
- First submitted
- 11 Jul 2017
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not to be shared with other researchers.
Publications
Cerullo C, Moller F, Ewan R, Norgaard B, Jakobsen TM. Vision-related quality of life in children: Cross-cultural adaptation and test-retest reliability of the Danish version of the paediatric refractive error profile 2. Acta Ophthalmol. 2024 Sep;102(6):e970-e983. doi: 10.1111/aos.16685. Epub 2024 Apr 13.
PubMed 38613420
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthokeratology Contact Lenses for the Treatment of Myopia in a Group of Danish Children
- ClinicalTrials.gov ID
- NCT03246464
- Acronym / sponsor ID
- CONTROL
- Conditions
- Myopia
- Keywords
- Contact lenses, Children, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Ens Eyes
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 11 Aug 2017 (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 is a common disease of the eye with increasing prevalence in the Western World as well as in South East Asia where 60-90% of the children are affected. High myopia is associated with an increasing risk of sight threatening complications such as retinal detachment, glaucoma, macular choroidal degeneration and myopic choroidal neovascularization. In myopia the eye is elongated compared to an emmetropic eye. If the elongation of the eye can be controlled the progression of myopia can be controlled. Asian studies have shown reduction in axial length growth by 36-46% in children using orthokeratology contact lenses (OKL). OKL are custom fit, form stable lenses. During sleep the cornea is reshaped creating an emmetropic vision during the day, so no glasses or contact lenses are needed. Twin and family studies have shown a high heritability for the development of myopia, and more than 40 genetic loci have been identified indicating that the effect of OKL in Asian children might not be the same in North European children which is why we want to execute a similar study on North European children.
Purpose:
- Investigate if nightly wear of OKL reduces the progression of childhood myopia (change in axial length) in Danish children when compared to a control group using monofocal glasses.
- Investigate the safety (Efron score) of OKL.
- Investigate children's quality of life impact of refractive correction (questionnaire) using OKL compared to glasses.
- Identify possible predictors for progression of myopia (AC/A ratio, peripheral defocus and higher order aberrations).
Method:
A randomized controlled 18 months prospective 1:1 study of a group of Danish children. 60 children will be included; 30 in each group. The participants will undergo several measurements reflecting the anatomy and function of the eye at baseline, 6, 12 and 18 month to evaluate the effect.
Detailed description
Myopia is a common disease of the eye with increasing prevalence in the Western World as well as in South East Asia where 60-90% of the children are affected. A Danish study found that early debut of myopia is associated with a higher degree of myopia later on in life. Myopia may be corrected with spectacles, contact lenses or surgically, but despite this socio-economic burden, high myopia is associated with an increasing risk of sight threatening complications such as retinal detachment, glaucoma, macular choroidal degeneration and myopic choroidal neovascularization.
Myopia is a complex disease with a multi-factorial etiology. Twin studies and family studies have shown a high heritability for development of myopia, and more than 40 genetic loci have been identified. Outdoor activity seems to reduce the myopia progression. The shape of the eye may be of importance; axial growth makes the eye ellipsoidal which increase the peripheral defocus on the retina. Peripheral defocus has been suggested to induce further axial growth of the eyeball.
Accommodation is a significant covariant of near work and reading. A cross section study has shown a reduced precision in accommodation (A) on a near object combined with increased convergence (C) in myopic eyes. This increased AC/A ratio (dynamic) may be a predictor for myopia progression.
Interventions for reducing myopia progression have been many. The effects of progressive additional lenses, multifocal lenses and bifocal lenses have been limited. Anticholinergic eyedrops (Atropin 0.01%) significantly reduce the progression of myopia in Asian children by approximately 50% over a period of two years with limited side effects. Almost similar results have been found in Asian children using orthokeratology contact lenses (OKL) for reducing myopia progression.
OKL are custom fit, form stable lenses used during sleep. The lenses induce a temporal flattening of the cornea, which modify or eliminate refractive errors, leaving no need for glasses or contact lenses during daytime. OKL were introduced in the 1960 ́s, but with limited success due the lens material (PMMA) which was not gas-permeable. Decentration was also a problem making the effect variable and unpredictable. With new gas- permeable lens materials and computer assisted topographic measurements of the cornea, fitting of the lenses has been improved significantly, so that nightly wear is now standard treatment.
A clear-cut reduction in axial length growth in Asian children using OKL compared to single-vision spectacles (SVS) has been proofed in several studies. In these studies, which are very heterogeneous regarding design, reductions of 36-46% in axial length growth were found compared to a matched control group. Two European prospective cohort studies have investigated the effect of OKL compared to SVS in Spanish children. A reduction in axial growth of 32 % and 38% respectively was found. Side effects of OKL have been evaluated; in a meta-analysis from 2015, including 8 Asian and one of the European studies. Odds Ratio for side effects were 8.87 for the OK group compared to the control group, however all side effects were mild and disappeared after termination of the treatment.
Thus, a reduction in childhood myopia using OKL has been proofed in Asian children; however, weather similar result can be achieved in a group of children from Northern Europe is unknown. The influence of OKL on quality of life impact of refractive correction has never been investigated in a randomized trail. How OKL reduce the axial growth of the eye is unknown. The lenses induce multifocality and higher order aberrations in the cornea, which might change the peripheral defocus. A change in defocus has been suggested as a mechanism for controlling axial length growth.
Primary goals:
In a randomized 18 months prospective 1:1 study of a group of Danish children to:
- Investigate if nightly wear of OKL (DreamliteR, Procornea, Nederlands) may reduce the progression of childhood myopia (change in axial length) when compared to a control group using SVS.
- Investigate safety (Efron score) in the use of OKL.
- Compare children's quality of life impact of refractive correction (questionnaire) using OKL and glasses.
- Identify possible predictors for progression of myopia (AC/A ratio, peripheral defocus and higher order aberrations).
Hypothesis:
- Nightly wear of OKL reduces the progression of childhood myopia in Danish children.
- Use of OKL is safe, with no sight threatening complications during 18 months of nightly treatment.
- Children using OKL experience a higher quality of life impact of refractive correction compared to children wearing SVS.
- Response AC/A ratio is positively correlated to progression of childhood myopia.
- Use of OKL induce changes in corneal topography resulting in (1) decreased peripheral defocus (2) increased number of higher order aberrations. Progression in childhood myopia is associated to changes in peripheral defocus and higher order aberrations.
Design:
A 18-month randomized prospective 1:1 study of progression of myopia in a group of Danish children wearing OKL nightly (n=30) compared to a control group wearing SVS (n=30).
Children randomized to OKL will be examined at BL and day 3 and 7 as well as month 1, 3, 6, 9, 12, 15, and 18 after the start of treatment with OKL (T0).
Children randomized to SVS will be examined at BL and month 6, 12 and 18 after receiving new glasses with optimal prescription (T0).
Examination:
- Best corrected (using "push plus" refraction principle) ETDRS visual acuity: The OKL group (2-4 hours after lens removal) at BL and day 3 and 7 as well as month 1, 3, 6, 9, 12, 15, and 18 after T0. The SVS group at BL and month 6, 12 and 18 after T0.
- Grading contact lens complications (Efron Grading Scale for Contact Lens Complications) for the OKL group at day 3 and 7 as well as month 1, 3, 6, 9,12, 15, and 18 after T0.
- Dynamic auto-refraction (Shin-Nippon SRW-5000, Kagawa, Japan) for both groups at a distance of 40 cm in primary gaze as well as 5, 10, 20 and 30 degrees eccentric to the nasal and temporal retina in the horizontal meridian at BL and month 6, 12 and 18 after T0.
- Measurements of convergence for both groups at a distance of 40 cm and 6 meter using the Eye-Link 1000 (SR Research, Ontario, Canada) at BL and month 6, 12 and 18 after T0.
- Cycloplegic auto-refraction at BL, 6, 12, and 18 months (Topcon KR-800, Topcon Europe Medical, Capelle aan den Ijss, Nederlands).
- Axial length measurements (Lensstar, LS900, Carl Zeiss, Haag-Streit, Koeniz, Switzerland) at BL, 6, 12 and 18 months after T0 for both patients groups.
- Pentacam (Oculus, Wetzlar, Germany) for the OKL group at BL, T0, day 3, 7 as well as month 1, 3, 6, 9, 12, 15, and 18 after T0 (measurements obtained 2-4 hours after lens removal). For the group wearing SVS at BL, and month 6, 12 and 18 after T0.
- Pediatric Refractive Error Profile 2 (questionnaire) will be performed at 12 month for both patient groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controled clinical interventional trial
| Arm | Type | Receives |
|---|---|---|
| Single-vision spectacles | Placebo comparator | Device: Single-vision spectacles |
| Orthokeratology lenses | Active comparator | Device: Orthokeratology lenses |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Myopia -0.5 to -4.75 dioptries spherical in one or both eyes.
- Regular astigmatism ≤ -2.5 diopters in one or both eyes.
- Age 6 ≥ 12 years.
- Anisometropia < 1.5 D spherical equivalent.
- Best corrected visual acuity of 0.1 logMAR or better in both eyes.
Key exclusion criteria (6 listed)
- Manifest or latent squint.
- Contraindications to the use of OKL comprising keratoconus, allergic conjunctivitis and keratoconjunctivitis sicca.
- Previous eye surgery.
- Chronic eye disease demanding daily use of eye drops.
- Non-compliance to eye examinations (unstable fixation or intolerance to OKL).
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 |
|---|---|---|
| Orthokeratology lensesRigid gas permeable contact lenses | Device | Orthokeratology lenses |
| Single-vision spectaclesRegular single vision spectacles | Device | Single-vision spectacles |
Primary outcome
Progression of myopia defined as change in axial length 18 months after start of intervention
Time frame: Follow up to 18 months
3 secondary outcomes
Quality of life comparison between myopic children wearing glasses and orthokeratology lenses using the Pediatric Refractive Error Profile 2 Questionnaire
Time frame: Follow up to 18 months
Safety evaluation by Efron scores for orthokeratology lenses
Time frame: Follow up to 18 months
Accommodation and higher-order aberrations
Time frame: Follow up to 18 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 28 May 2020.
- Derived from this study: PubMed 38613420Cerullo C, Moller F, Ewan R, Norgaard B, Jakobsen TM. Vision-related quality of life in children: Cross-cultural adaptation and test-retest reliability of the Danish version of the paediatric refractive error profile 2. Acta Ophthalmol. 2024 Sep;102(6):e970-e983. doi: 10.1111/aos.16685. Epub 2024 Apr 13.
- Individual participant dataSharing planned: No. IPD is not to be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthokeratology lenses and Single-vision spectacles in people with Myopia, run by Vejle Hospital at 1 site in Denmark.
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 6 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 28 May 2020. 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 Denmark. 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?
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?
Progression of myopia defined as change in axial length 18 months after start of intervention (time frame: Follow 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 NCT03246464, 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 May 2020.