MyopiaNCT03881358
Orthokeratology for High Myopia (OHM) Study
A study testing ortho-k lenses and thinner spectacles and newly designed ortho-k lenses in people with Myopia and High Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This project aims to investigate/examine high myopic subjects on full correction ortho-k (using Topaz ortho-k lenses for high myopia) compared to subjects undergoing partial reduction ortho-k and their relationship with myopia and myopic progression. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, High Myopia
- What is being tested?
- ortho-k lenses and thinner spectacles and newly designed ortho-k lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Aug 2018to Jan 2024
- 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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Myopia: at least 5.00D in one eye or in both eyes
- Astigmatism: ≤1.50D; with-the-rule astigmatism (axes 180 ± 30) ≤1.25D; astigmatism of other axes ≤0.50D in both eyes
- Anisometropia: not be more than 1.00D in the former and not more than 2.00D in the latter.
- Best-corrected Monocular Snellen visual acuity 6/7.5 or better
Who cannot join
- Strabismus at distance or near
- Previous experience in contact lens wear or myopia control treatment (e.g. refractive therapy or progressive spectacles)
- Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex)
- Previous history of ocular surgery, trauma, or chronic ocular disease
- Concurrent use of medications that may affect tear quality or contact lens wear
- Systemic or ocular conditions that may affect tear quality or contact lens wear (e.g allergy and concurrent medication) or that may affect refractive development (e.g Down syndrome, ptosis)
- Poor compliance to tests (e.g poor fixation in noncontact tonometry or intolerance of lens wear)
- Not willing to comply with the allocated treatment, use and care of lenses and follow-up schedule
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Optometry, The Hong Kong Polytechnic University
Kowloon
Pauline Cho, PhD, (+852)2766 6100, pauline.cho@polyu.edu.hk
Yajing Yang, BSc, (+852)6486 2435, grace.yj.yang@connect.polyu.hk
About this study
This project aims to investigate/examine high myopic subjects on full correction ortho-k (using Topaz ortho-k lenses for high myopia) compared to subjects undergoing partial reduction ortho-k and their relationship with myopia and myopic progression.
Read the detailed description
For many years, commercially-available ortho-k lenses aim to reduce low - moderate myopia. Attempts to use these lenses for reduction of high myopia have been shown to give rise to complications such as corneal staining and lens decentration. Thus, practitioners may choose a more conservative way for high myopic children, that is, offering partial reduction ortho-k. Partial reduction ortho-k is target for 4.00-5.00D reduction and the residual refractive errors will be corrected with single vision spectacles to allow good visual acuity in the daytime. Partial reduction ortho-k has been shown to slow axial elongation in high myopic children, however, the main disadvantage is that the children have to wear spectacles in the daytime to correct residual refraction.
Euclid has recently designed a new lens, Euclid's Topaz, for high myopic children. It is currently commercially available to correct myopia for up to 10 D. However, evidence of its effectiveness for visual correction and slowing AL growth is lacking. While numerous studies have shown that orthokeratology is an effective clinical treatment to slow axial eye growth in children, the exact mechanism underlying this reduction in myopia progression associated with orthokeratology remains unclear.
- Conditions
- Myopia, High Myopia
- Being tested
- ortho-k lenses and thinner spectacles, newly designed ortho-k lenses
- Keywords
- Myopia control, Orthokeratology, Children
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ortho-k lenses and thinner spectaclesDevice
Conventinally designed (Emerald) ortho-k lenses (target for -4.00D) and thinner specs during day time
newly designed ortho-k lensesDevice
Newly designed (Topaz) ortho-k lenses for high myopia (target for full correction)
| Study group | Role | What they receive |
|---|---|---|
| ortho-k lenses and thinner spectacles | Active comparator | participants using conventionally designed ortho-k lenses (target for 4.00D) and thinner spectacles during day time Receives: Device: ortho-k lenses and thinner spectacles |
| newly designed ortho-k lenses | Experimental | participants using newly designed ortho-k lenses for high myopia (target for full correction) Receives: Device: newly designed ortho-k lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in axial length elongation over 24 months.
To determine the change in axial length measured at baseline and two years after lens wear using IOLMaster
Measured: 2 years
Secondary outcomes (3)
First fit success rate of a newly designed ortho-k lens for high myopic children
The success rate in using the first pair of lenses to achieve target refractive correction will be determined
Measured: 1 month
Quality of life (questionnaire)
Quality of life will be determined by questionnaires (using revised Pediatric Refractive Error Profile (PREP) 1 in traditional Chinese version) before and after ortho-k in the two groups of subjects
Measured: 3 months
Ocular aberration
Ocular aberration will be measured by Complete Ophthalmic Analysis System (COAS) aberrometer
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 Mar 2019
- Study start4 Aug 2018
- Primary completionNov 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Queensland University of Technology, Aston University
- 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
- NCT03881358
- Sponsor's protocol ID
- HSEARS20180322002
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lam CS, Goldschmidt E, Edwards MH. Prevalence of myopia in local and international schools in Hong Kong. Optom Vis Sci. 2004 May;81(5):317-22. doi: 10.1097/01.opx.0000134905.98403.18.
PubMed 15181356Walline JJ, Lindsley K, Vedula SS, Cotter SA, Mutti DO, Twelker JD. Interventions to slow progression of myopia in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD004916. doi: 10.1002/14651858.CD004916.pub3.
PubMed 22161388Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.
PubMed 21212181Cho 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 15875367Swarbrick HA. Orthokeratology review and update. Clin Exp Optom. 2006 May;89(3):124-43. doi: 10.1111/j.1444-0938.2006.00044.x.
PubMed 16637967Walline 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 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 23518209Cho P, Cheung SW, Edwards MH. Practice of orthokeratology by a group of contact lens practitioners in Hong Kong. Part 2: orthokeratology lenses. Clin Exp Optom. 2003 Jan;86(1):42-6. doi: 10.1111/j.1444-0938.2003.tb03056.x.
PubMed 12568650Lee TT, Cho P. Relative peripheral refraction in children: twelve-month changes in eyes with different ametropias. Ophthalmic Physiol Opt. 2013 May;33(3):283-93. doi: 10.1111/opo.12057.
PubMed 23662961Atchison DA, Li SM, Li H, Li SY, Liu LR, Kang MT, Meng B, Sun YY, Zhan SY, Mitchell P, Wang N. Relative Peripheral Hyperopia Does Not Predict Development and Progression of Myopia in Children. Invest Ophthalmol Vis Sci. 2015 Sep 1;56(10):6162-70. doi: 10.1167/iovs.15-17200.
PubMed 26397463Hiraoka T, Matsumoto Y, Okamoto F, Yamaguchi T, Hirohara Y, Mihashi T, Oshika T. Corneal higher-order aberrations induced by overnight orthokeratology. Am J Ophthalmol. 2005 Mar;139(3):429-36. doi: 10.1016/j.ajo.2004.10.006.
PubMed 15767050Gonzalez-Meijome JM, Villa-Collar C, Queiros A, Jorge J, Parafita MA. Pilot study on the influence of corneal biomechanical properties over the short term in response to corneal refractive therapy for myopia. Cornea. 2008 May;27(4):421-6. doi: 10.1097/ICO.0b013e318164e49d.
PubMed 18434845Yang Y, Vincent SJ, Cheung SW, Cho P, Chan HHL. Vision-related quality of life in highly myopic children undergoing orthokeratology treatment. Cont Lens Anterior Eye. 2026 Feb;49(1):102580. doi: 10.1016/j.clae.2025.102580. Epub 2025 Dec 6.
PubMed 41353876
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthokeratology for High Myopia (OHM) Study
- ClinicalTrials.gov ID
- NCT03881358
- Acronym / sponsor ID
- HSEARS20180322002
- Conditions
- Myopia, High Myopia
- Keywords
- Myopia control, Orthokeratology, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Queensland University of Technology, Aston University
- Study start
- 4 Aug 2018 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 19 Mar 2019 (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.
This project aims to investigate/examine high myopic subjects on full correction ortho-k (using Topaz ortho-k lenses for high myopia) compared to subjects undergoing partial reduction ortho-k and their relationship with myopia and myopic progression.
Detailed description
For many years, commercially-available ortho-k lenses aim to reduce low - moderate myopia. Attempts to use these lenses for reduction of high myopia have been shown to give rise to complications such as corneal staining and lens decentration. Thus, practitioners may choose a more conservative way for high myopic children, that is, offering partial reduction ortho-k. Partial reduction ortho-k is target for 4.00-5.00D reduction and the residual refractive errors will be corrected with single vision spectacles to allow good visual acuity in the daytime. Partial reduction ortho-k has been shown to slow axial elongation in high myopic children, however, the main disadvantage is that the children have to wear spectacles in the daytime to correct residual refraction.
Euclid has recently designed a new lens, Euclid's Topaz, for high myopic children. It is currently commercially available to correct myopia for up to 10 D. However, evidence of its effectiveness for visual correction and slowing AL growth is lacking. While numerous studies have shown that orthokeratology is an effective clinical treatment to slow axial eye growth in children, the exact mechanism underlying this reduction in myopia progression associated with orthokeratology remains unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ortho-k lenses and thinner spectacles | Active comparator | Device: ortho-k lenses and thinner spectaclesparticipants using conventionally designed ortho-k lenses (target for 4.00D) and thinner spectacles during day time |
| newly designed ortho-k lenses | Experimental | Device: newly designed ortho-k lensesparticipants using newly designed ortho-k lenses for high myopia (target for full correction) |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Myopia: at least 5.00D in one eye or in both eyes
- Astigmatism: ≤1.50D; with-the-rule astigmatism (axes 180 ± 30) ≤1.25D; astigmatism of other axes ≤0.50D in both eyes
- Anisometropia: not be more than 1.00D in the former and not more than 2.00D in the latter.
- Best-corrected Monocular Snellen visual acuity 6/7.5 or better
Key exclusion criteria (8 listed)
- Strabismus at distance or near
- Previous experience in contact lens wear or myopia control treatment (e.g. refractive therapy or progressive spectacles)
- Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex)
- Previous history of ocular surgery, trauma, or chronic ocular disease
- Concurrent use of medications that may affect tear quality or contact lens wear
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 |
|---|---|---|
| ortho-k lenses and thinner spectaclesConventinally designed (Emerald) ortho-k lenses (target for -4.00D) and thinner specs during day time | Device | ortho-k lenses and thinner spectacles |
| newly designed ortho-k lensesNewly designed (Topaz) ortho-k lenses for high myopia (target for full correction) | Device | newly designed ortho-k lenses |
Primary outcome
Change in axial length elongation over 24 months.
Time frame: 2 years
To determine the change in axial length measured at baseline and two years after lens wear using IOLMaster
3 secondary outcomes
First fit success rate of a newly designed ortho-k lens for high myopic children
Time frame: 1 month
Quality of life (questionnaire)
Time frame: 3 months
Ocular aberration
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 15181356Lam CS, Goldschmidt E, Edwards MH. Prevalence of myopia in local and international schools in Hong Kong. Optom Vis Sci. 2004 May;81(5):317-22. doi: 10.1097/01.opx.0000134905.98403.18.
- Background: PubMed 22161388Walline JJ, Lindsley K, Vedula SS, Cotter SA, Mutti DO, Twelker JD. Interventions to slow progression of myopia in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD004916. doi: 10.1002/14651858.CD004916.pub3.
- Background: PubMed 21212181Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.
- 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 16637967Swarbrick HA. Orthokeratology review and update. Clin Exp Optom. 2006 May;89(3):124-43. doi: 10.1111/j.1444-0938.2006.00044.x.
- 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.
- Background: 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.
- Background: PubMed 12568650Cho P, Cheung SW, Edwards MH. Practice of orthokeratology by a group of contact lens practitioners in Hong Kong. Part 2: orthokeratology lenses. Clin Exp Optom. 2003 Jan;86(1):42-6. doi: 10.1111/j.1444-0938.2003.tb03056.x.
- Background: PubMed 23662961Lee TT, Cho P. Relative peripheral refraction in children: twelve-month changes in eyes with different ametropias. Ophthalmic Physiol Opt. 2013 May;33(3):283-93. doi: 10.1111/opo.12057.
- Background: PubMed 26397463Atchison DA, Li SM, Li H, Li SY, Liu LR, Kang MT, Meng B, Sun YY, Zhan SY, Mitchell P, Wang N. Relative Peripheral Hyperopia Does Not Predict Development and Progression of Myopia in Children. Invest Ophthalmol Vis Sci. 2015 Sep 1;56(10):6162-70. doi: 10.1167/iovs.15-17200.
- Background: PubMed 15767050Hiraoka T, Matsumoto Y, Okamoto F, Yamaguchi T, Hirohara Y, Mihashi T, Oshika T. Corneal higher-order aberrations induced by overnight orthokeratology. Am J Ophthalmol. 2005 Mar;139(3):429-36. doi: 10.1016/j.ajo.2004.10.006.
- Background: PubMed 18434845Gonzalez-Meijome JM, Villa-Collar C, Queiros A, Jorge J, Parafita MA. Pilot study on the influence of corneal biomechanical properties over the short term in response to corneal refractive therapy for myopia. Cornea. 2008 May;27(4):421-6. doi: 10.1097/ICO.0b013e318164e49d.
- Individual participant dataSharing planned: Undecided
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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 ortho-k lenses and thinner spectacles and newly designed ortho-k lenses in people with Myopia and High 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline Cho, PhD ((+852) 2766 6100, pauline.cho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in axial length elongation over 24 months. (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 NCT03881358, which also lists 13 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 16 Feb 2021.