MyopiaHM-PRONCT00977236
Myopic Control for High Myopes Using Orthokeratology
A study testing Orthokeratology lenses and Single-vision spectacle lenses in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Orthokeratology lenses and Single-vision spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Dec 2012
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Myopia (refractive sphere): > 5.75D
- Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
- Spherical equivalent (SE): > 5.75D
- Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
- Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
- Willingness for randomization
- Availability for follow-up for at least 2 years
Who cannot join
- Strabismus at distance or near
- Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
- Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
- Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
Trial locations and contacts
1 site in 1 country.
China1 site
School of Optometry, The Hong Kong Polytechnic University
Hong Kong SAR
About this study
Official title: High Myopia - Partial Reduction Orthokeratology Study
The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.
Read the detailed description
Orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic progression in low myopes. To date, clinical experience has shown the technique to be less effective in achieving full myopic reduction in high myopes. Would myopic control be possible for high myopes undergoing partial correction ortho-k treatment?
A randomized, longitudinal study is designed to investigate the efficacy of partial correction ortho-k in retardation of myopic progression in high myopic children. Eye growth in terms of axial length elongation in children wearing ortho-k and over-spectacles (to correct residual refractive errors) (study group) and those wearing single-vision spectacles (control group) will be evaluated and compared.
- Conditions
- Myopia
- Being tested
- Orthokeratology lenses, Single-vision spectacle lenses
- Keywords
- children, corneal reshaping, myopia, myopia control, orthokeratology
- 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
Also called Corneal reshaping therapy
Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years
Single-vision spectacle lensesDevice
Also called Glasses, Spectacles
Daily use of spectacles to correct the refractive error for a period of two years
| Study group | Role | What they receive |
|---|---|---|
| Orthokeratology lenses | Experimental | Children wearing orthokeratology at night for partial correction and spectacles at daytime for residual refractive error will be study group Receives: Device: Orthokeratology lenses |
| Single-vision spectacle lenses | Other | Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group Receives: Device: Single-vision spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the change in cycloplegic axial length in the study and control groups
Measured: 2 years
Secondary outcomes (2)
Determine the incidence of adverse effects in cornea, the palpebral, bulbar and tarsal conjunctiva in the study and the control groups
Measured: 2 years
Rate of regression during the daytime
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startJul 2008
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Procornea Nederland B.V.
- Responsible party
- Principal investigator, Pauline Cho, The Hong Kong Polytechnic University
- Investigators
- Pauline Cho, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977236
- Sponsor's protocol ID
- 4-RP3M
- Acronym
- HM-PRO
- Status last verified
- Jul 2013
- First submitted
- 14 Sep 2009
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cho P, Cheung SW, Edwards M. The longitudinal orthokeratology research in children (LORIC) in Hong Kong: a pilot study on refractive changes and myopic control. Curr Eye Res. 2005 Jan;30(1):71-80. doi: 10.1080/02713680590907256.
PubMed 15875367Walline JJ, Jones LA, Sinnott LT. Corneal reshaping and myopia progression. Br J Ophthalmol. 2009 Sep;93(9):1181-5. doi: 10.1136/bjo.2008.151365. Epub 2009 May 4.
PubMed 19416935Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d.
PubMed 23645372Charm J, Cho P. High myopia-partial reduction orthokeratology (HM-PRO): study design. Cont Lens Anterior Eye. 2013 Aug;36(4):164-70. doi: 10.1016/j.clae.2013.02.012. Epub 2013 Mar 18.
PubMed 23518209Lawrenson 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 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Myopia - Partial Reduction Orthokeratology Study
- ClinicalTrials.gov ID
- NCT00977236
- Acronym / sponsor ID
- HM-PRO / 4-RP3M
- Conditions
- Myopia
- Keywords
- children, corneal reshaping, myopia, myopia control, orthokeratology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Procornea Nederland B.V.
- Study start
- Jul 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Sep 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.
The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.
Detailed description
Orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic progression in low myopes. To date, clinical experience has shown the technique to be less effective in achieving full myopic reduction in high myopes. Would myopic control be possible for high myopes undergoing partial correction ortho-k treatment?
A randomized, longitudinal study is designed to investigate the efficacy of partial correction ortho-k in retardation of myopic progression in high myopic children. Eye growth in terms of axial length elongation in children wearing ortho-k and over-spectacles (to correct residual refractive errors) (study group) and those wearing single-vision spectacles (control group) will be evaluated and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthokeratology lenses | Experimental | Device: Orthokeratology lensesChildren wearing orthokeratology at night for partial correction and spectacles at daytime for residual refractive error will be study group |
| Single-vision spectacle lenses | Other | Device: Single-vision spectacle lensesChildren wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Myopia (refractive sphere): > 5.75D
- Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
- Spherical equivalent (SE): > 5.75D
- Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
- Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
Key exclusion criteria (4 listed)
- Strabismus at distance or near
- Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
- Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
- Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
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 lensesAlso: Corneal reshaping therapyNightly use of orthokeratology to correct the refractive error and over-specs for a period of two years | Device | Orthokeratology lenses |
| Single-vision spectacle lensesAlso: Glasses, SpectaclesDaily use of spectacles to correct the refractive error for a period of two years | Device | Single-vision spectacle lenses |
Primary outcome
Determine the change in cycloplegic axial length in the study and control groups
Time frame: 2 years
2 secondary outcomes
Determine the incidence of adverse effects in cornea, the palpebral, bulbar and tarsal conjunctiva in the study and the control groups
Time frame: 2 years
Rate of regression during the daytime
Time frame: 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 12 Jul 2013.
- Results publication: PubMed 15875367Cho P, Cheung SW, Edwards M. The longitudinal orthokeratology research in children (LORIC) in Hong Kong: a pilot study on refractive changes and myopic control. Curr Eye Res. 2005 Jan;30(1):71-80. doi: 10.1080/02713680590907256.
- Results publication: PubMed 19416935Walline JJ, Jones LA, Sinnott LT. Corneal reshaping and myopia progression. Br J Ophthalmol. 2009 Sep;93(9):1181-5. doi: 10.1136/bjo.2008.151365. Epub 2009 May 4.
- Results publication: PubMed 23645372Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d.
- Results publication: PubMed 23518209Charm J, Cho P. High myopia-partial reduction orthokeratology (HM-PRO): study design. Cont Lens Anterior Eye. 2013 Aug;36(4):164-70. doi: 10.1016/j.clae.2013.02.012. Epub 2013 Mar 18.
- 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.
- High myopia-partial reduction ortho-k: a 2-year randomized studyLink provided by the sponsor.
- High myopia-partial reduction orthokeratology (HM-PRO): Study design.Link provided by the sponsor.
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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 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 Orthokeratology lenses and Single-vision spectacle lenses 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 7 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 12 Jul 2013. 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?
Determine the change in cycloplegic axial length in the study and control groups (time frame: 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 NCT00977236, which also lists 5 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 12 Jul 2013.