MyopiaROMIONCT00962208
Retardation of Myopia in 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 primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles. Read more about this study
- Who is it for?
- Ages 6 to 10 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
- 102 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Myopia (refractive sphere): > 0.50D and ≤ 4.00D
- Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
- Spherical equivalent (SE): > 0.75D and ≤ 4.50D
- 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
- Willingness to wear contact lenses or spectacles on a daily basis
- 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
- Prior experience with the use of rigid lenses (including orthokeratology)
- Prior experience with myopia control treatment (e.g. refractive therapy or progressive add spectacles)
- 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, Hong Kong
About this study
Official title: Orthokeratology for Myopic Control in Chinese Children - a Randomized Clinical Trial
The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.
Read the detailed description
Prevalence of myopia is high in Asian countries like Hong Kong. Orthokeratology has shown potential in slowing myopic progression but the efficacy is yet to be confirmed by a randomized clinical trial (RCT). The current RCT aims at studying the efficacy of orthokeratology in retardation of myopic progression by comparing the eye growth in terms of axial length elongation in children wearing orthokeratology lenses (study group) and those wearing single-vision spectacles (control group).
- 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, Menicon Z Night Lens
Nightly use of orthokeratology to correct the refractive error for a period of two years
single-vision spectacle lensesDevice
Also called CR-39 lenses
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 correcting of 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.
Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study
Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.
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
Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear
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 posted19 Aug 2009 (estimated)
- Study startMar 2008
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Menicon Co., Ltd.
- 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
- NCT00962208
- Sponsor's protocol ID
- H-ZG13
- Acronym
- ROMIO
- Status last verified
- Jul 2013
- First submitted
- 18 Aug 2009
- Last updated
- 28 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19416935Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012 Oct 11;53(11):7077-85. doi: 10.1167/iovs.12-10565.
PubMed 22969068Lawrenson 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 36809645Cheung SW, Cho P. Validity of axial length measurements for monitoring myopic progression in orthokeratology. Invest Ophthalmol Vis Sci. 2013 Mar 5;54(3):1613-5. doi: 10.1167/iovs.12-10434.
PubMed 23361504Chan KY, Cheung SW, Cho P. Clinical performance of an orthokeratology lens fitted with the aid of a computer software in Chinese children. Cont Lens Anterior Eye. 2012 Aug;35(4):180-4. doi: 10.1016/j.clae.2012.01.004. Epub 2012 Mar 3.
PubMed 22390958
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthokeratology for Myopic Control in Chinese Children - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00962208
- Acronym / sponsor ID
- ROMIO / H-ZG13
- Conditions
- Myopia
- Keywords
- children, corneal reshaping, myopia, myopia control, orthokeratology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Menicon Co., Ltd.
- Study start
- Mar 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Posted 20 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.
Detailed description
Prevalence of myopia is high in Asian countries like Hong Kong. Orthokeratology has shown potential in slowing myopic progression but the efficacy is yet to be confirmed by a randomized clinical trial (RCT). The current RCT aims at studying the efficacy of orthokeratology in retardation of myopic progression by comparing the eye growth in terms of axial length elongation in children wearing orthokeratology lenses (study group) and those wearing single-vision spectacles (control group).
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 correcting of 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
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Myopia (refractive sphere): > 0.50D and ≤ 4.00D
- Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
- Spherical equivalent (SE): > 0.75D and ≤ 4.50D
- 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 (6 listed)
- Strabismus at distance or near
- Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
- Prior experience with the use of rigid lenses (including orthokeratology)
- Prior experience with myopia control treatment (e.g. refractive therapy or progressive add spectacles)
- Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
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 therapy, Menicon Z Night LensNightly use of orthokeratology to correct the refractive error for a period of two years | Device | orthokeratology lenses |
| single-vision spectacle lensesAlso: CR-39 lensesDaily use of spectacles to correct the refractive error for a period of two years | Device | single-vision spectacle lenses |
Primary outcome
Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study
Time frame: 2 years
Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.
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
Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Background: 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 22969068Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012 Oct 11;53(11):7077-85. doi: 10.1167/iovs.12-10565.
- 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.
- Derived from this study: PubMed 23361504Cheung SW, Cho P. Validity of axial length measurements for monitoring myopic progression in orthokeratology. Invest Ophthalmol Vis Sci. 2013 Mar 5;54(3):1613-5. doi: 10.1167/iovs.12-10434.
- Derived from this study: PubMed 22390958Chan KY, Cheung SW, Cho P. Clinical performance of an orthokeratology lens fitted with the aid of a computer software in Chinese children. Cont Lens Anterior Eye. 2012 Aug;35(4):180-4. doi: 10.1016/j.clae.2012.01.004. Epub 2012 Mar 3.
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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 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 8 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 Oct 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?
Yes. Results are posted in the registry (first posted 20 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study (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 NCT00962208, which also lists 6 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 28 Oct 2013.