MyopiaDOEE2NCT01236755
Discontinuation of Lens Wear in New Ortho-k Children (DOEE2)
A study testing single-vision glasses and ortho-k lenses in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- single-vision glasses and ortho-k lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2013
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: between 6 to 15 years old
- Myopia: between 1.50D and 4.50D in at least one eye
- Spherical equivalent (SE): between -1.00D to -4.50D in both eyes
- Astigmatism: ≤ 3.00D of axes 180 +/- 30 or ≤ 1.00D of other axes; and the amount is less than refractive sphere
- 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
Show all 9Show fewer
- Willingness to wear contact lenses or spectacles on a daily basis
- Can obtain good ortho-k results with the study lenses
- Availability for follow-up for at least 14 months
Who cannot join
- Strabismus at distance or near
- Contraindication for contact lens wear and ortho-k (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)
- Prior experience with the use of rigid lenses (including ortho-k)
- Prior experience with myopia control treatment (e.g. refractive therapy or progressive spectacles)
Show all 10Show fewer
- Non-compliance to the follow up schedule
- Non-compliance to the use of the prescribed optical correction
- Poor ocular response to ortho-k lens wear
- Significant residual refractive error after ortho-k treatment resulting in poor unaided vision (worse than 0.18 in logMAR scale)
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: Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (2) Discontinuation of Lens Wear in New Ortho-k Children
This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children.
Read the detailed description
Children wearing ortho-k have been shown to have slower rate of myopic progression than those wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009). Younger myopic children (aged 6-10 years old) may have the faster increase in myopia than old myopic children (aged 11-15 years old), i.e. the rate of myopic progression may be different in different age groups and in children with different refractive status (Edwards 1999; Fan et al. 2004; Cheng et al. 2007). Although the refractive correction with ortho-k has been well documented, it is unknown whether the efficiency and reversibility of ortho-k for myopic reduction as well as myopic control are similar in children of different age and refractive groups.
In this 14-month study, the eyeball length in 45 younger (6-10 years old) and 45 older (11-15 years old) myopic children before and after ortho-k will be evaluated. Eyeball elongation will be determined for the first 7 months when single-vision glasses will be prescribed (Phase I) and the next 7 months when ortho-k will be prescribed (Phase I). Rate of myopic progression will be determined and compared between the two groups of children in the two phases.
- Conditions
- Myopia
- Being tested
- single-vision glasses, ortho-k lenses
- Keywords
- children, corneal reshaping, myopia, myopia progression, orthokeratology
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-vision glassesDevice
Also called CR-39 lenses
Daily wear of glasses to correct vision in the first seven months of the study
ortho-k lensesDevice
Also called orthokeratology, corneal reshaping therapy, Menicon Z Night lenses, Menicon Z Night Toric lenses
Nightly wear of lenses to correct vision in day time in the second seven months of the study
| Study group | Role | What they receive |
|---|---|---|
| ortho-k lenses | Experimental | Children were switched to wear ortho-k lenses for 7 months after wearing single-vision glasses for 7 months Receives: Device: single-vision glasses; Device: ortho-k lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Axial Elongation in the Two Study Phases
Axial elongation in children during the two study phases. Phase I: 7 months wearing single-vision spectacles. Phase II: 7 months wearing orthokeratology
Measured: 14 months
Secondary outcomes (1)
Number of Participants With Serious Adverse Effects
Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2013
- Study completionDec 2013
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
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects were prescribed with a pair of glasses for seven months and switched to orthokeratology for another seven months
- Masking
- Single blind
- Enrolment
- 91 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
- NCT01236755
- Sponsor's protocol ID
- H-ZG50-2
- Acronym
- DOEE2
- Status last verified
- Feb 2020
- First submitted
- 8 Nov 2010
- Last updated
- 11 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cheng D, Schmid KL, Woo GC. Myopia prevalence in Chinese-Canadian children in an optometric practice. Optom Vis Sci. 2007 Jan;84(1):21-32. doi: 10.1097/01.opx.0000254042.24803.1f.
PubMed 17220775Cho 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 15875367Edwards MH. The development of myopia in Hong Kong children between the ages of 7 and 12 years: a five-year longitudinal study. Ophthalmic Physiol Opt. 1999 Jul;19(4):286-94. doi: 10.1046/j.1475-1313.1999.00445.x.
PubMed 10645384Fan DS, Lam DS, Lam RF, Lau JT, Chong KS, Cheung EY, Lai RY, Chew SJ. Prevalence, incidence, and progression of myopia of school children in Hong Kong. Invest Ophthalmol Vis Sci. 2004 Apr;45(4):1071-5. doi: 10.1167/iovs.03-1151.
PubMed 15037570Walline 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 19416935Cheung SW, Boost MV, Cho P. Pre-treatment observation of axial elongation for evidence-based selection of children in Hong Kong for myopia control. Cont Lens Anterior Eye. 2019 Aug;42(4):392-398. doi: 10.1016/j.clae.2018.10.006. Epub 2018 Oct 24.
PubMed 30366778
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (2) Discontinuation of Lens Wear in New Ortho-k Children
- ClinicalTrials.gov ID
- NCT01236755
- Acronym / sponsor ID
- DOEE2 / H-ZG50-2
- Conditions
- Myopia
- Keywords
- children, corneal reshaping, myopia, myopia progression, orthokeratology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Menicon Co., Ltd.
- Study start
- Oct 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children.
Detailed description
Children wearing ortho-k have been shown to have slower rate of myopic progression than those wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009). Younger myopic children (aged 6-10 years old) may have the faster increase in myopia than old myopic children (aged 11-15 years old), i.e. the rate of myopic progression may be different in different age groups and in children with different refractive status (Edwards 1999; Fan et al. 2004; Cheng et al. 2007). Although the refractive correction with ortho-k has been well documented, it is unknown whether the efficiency and reversibility of ortho-k for myopic reduction as well as myopic control are similar in children of different age and refractive groups.
In this 14-month study, the eyeball length in 45 younger (6-10 years old) and 45 older (11-15 years old) myopic children before and after ortho-k will be evaluated. Eyeball elongation will be determined for the first 7 months when single-vision glasses will be prescribed (Phase I) and the next 7 months when ortho-k will be prescribed (Phase I). Rate of myopic progression will be determined and compared between the two groups of children in the two phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
- Model description
- All subjects were prescribed with a pair of glasses for seven months and switched to orthokeratology for another seven months
| Arm | Type | Receives |
|---|---|---|
| ortho-k lenses | Experimental | Device: single-vision glasses, Device: ortho-k lensesChildren were switched to wear ortho-k lenses for 7 months after wearing single-vision glasses for 7 months |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age: between 6 to 15 years old
- Myopia: between 1.50D and 4.50D in at least one eye
- Spherical equivalent (SE): between -1.00D to -4.50D in both eyes
- Astigmatism: ≤ 3.00D of axes 180 +/- 30 or ≤ 1.00D of other axes; and the amount is less than refractive sphere
- Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
Key exclusion criteria (10 listed)
- Strabismus at distance or near
- Contraindication for contact lens wear and ortho-k (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)
- Prior experience with the use of rigid lenses (including ortho-k)
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 |
|---|---|---|
| single-vision glassesAlso: CR-39 lensesDaily wear of glasses to correct vision in the first seven months of the study | Device | ortho-k lenses |
| ortho-k lensesAlso: orthokeratology, corneal reshaping therapy, Menicon Z Night lenses, Menicon Z Night Toric lensesNightly wear of lenses to correct vision in day time in the second seven months of the study | Device | ortho-k lenses |
Primary outcome
Change in Axial Elongation in the Two Study Phases
Time frame: 14 months
Axial elongation in children during the two study phases. Phase I: 7 months wearing single-vision spectacles. Phase II: 7 months wearing orthokeratology
1 secondary outcome
Number of Participants With Serious Adverse Effects
Time frame: 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17220775Cheng D, Schmid KL, Woo GC. Myopia prevalence in Chinese-Canadian children in an optometric practice. Optom Vis Sci. 2007 Jan;84(1):21-32. doi: 10.1097/01.opx.0000254042.24803.1f.
- 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 10645384Edwards MH. The development of myopia in Hong Kong children between the ages of 7 and 12 years: a five-year longitudinal study. Ophthalmic Physiol Opt. 1999 Jul;19(4):286-94. doi: 10.1046/j.1475-1313.1999.00445.x.
- Background: PubMed 15037570Fan DS, Lam DS, Lam RF, Lau JT, Chong KS, Cheung EY, Lai RY, Chew SJ. Prevalence, incidence, and progression of myopia of school children in Hong Kong. Invest Ophthalmol Vis Sci. 2004 Apr;45(4):1071-5. doi: 10.1167/iovs.03-1151.
- 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 30366778Cheung SW, Boost MV, Cho P. Pre-treatment observation of axial elongation for evidence-based selection of children in Hong Kong for myopia control. Cont Lens Anterior Eye. 2019 Aug;42(4):392-398. doi: 10.1016/j.clae.2018.10.006. Epub 2018 Oct 24.
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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 single-vision glasses and ortho-k 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 9 inclusion and 10 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 11 Mar 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 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 19 Sep 2019). 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?
Change in Axial Elongation in the Two Study Phases (time frame: 14 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 NCT01236755, 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 11 Mar 2020.