MyopiaDOEE1NCT01236742

Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children

A study testing ortho-k lenses and single-vision glasses in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects who stop the treatment with subjects who continue ortho-k lens wear and control subjects wearing single-vision glasses. Read more about this study

Who is it for?: Ages 8 to 14 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: ortho-k lenses and single-vision glasses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteChina
Study dates: Jul 2010to Jun 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 8 to 14 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Age 8-14 years old (inclusive)
Subjects who have completed the ROMIO, TO-SEE or HM-PRO studies at The Hong Kong Polytechnic University
Willingness to be randomized into groups (for ortho-k subjects)
Availability for follow-up for at least 14 months

Who cannot join

Non-compliance to the follow up schedule
Non-compliance to the assigned optical correction (i.e. single-vision glasses or ortho-k lenses)
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)

Trial locations and contacts

1 site in 1 country.

China1 site

School of Optometry, The Hong Kong Polytechnic University
Hong Kong, Hong Kong

Other trials in China

About this study

Official title: Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (1) Discontinuation of Lens Wear in Existing Ortho-k 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). Both studies showed that the effect of myopic control was most significant during the first six months of the treatment. It is unknown whether the myopic control effect would dissipate upon the discontinuation of the treatment or whether the myopic control effect only happened in the first six month of lens wear and was maintained thereafter. The current study aims at evaluating the effect of discontinuation of ortho-k treatment on myopic control in children who are currently on the treatment. This knowledge is necessary and important as patients/parents have concerns about the permanent dependency on ortho-k once they enrolled in the treatment.

Children who have been on the treatment for two years and have recently completed the myopic control studies at The Hong Kong Polytechnic University, i.e. the ROMIO, TO-SEE and HM-PRO studies, will be invited to participate in this 14-month study. Ortho-k subjects will be randomly assigned to study group or the ortho-k control group. The study group subjects will be required to stop lens wear for 7 months at the completion of the previous study (Phase I) and resume lens wear for next 7 months (Phase II). The ortho-k control group subjects will be required to continue the current treatment for another 14 months. Control subjects in the existing myopic control studies will be required to continue using the same treatment, i.e. single-vision glasses, for another 14 months. Rate of myopic progression among the 3 groups and at the two study phases will be determined and compared.

Conditions: Myopia
Being tested: ortho-k lenses, single-vision glasses
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.

ortho-k lensesDevice
Also called orthokeratology, corneal reshaping therapy, Menicon Z Night lenses, Menicon Z Night Toric lenses
nightly wear of orthokeratology lenses to correct vision
single-vision glassesDevice
Also called CR-39 lenses
daily wear of spectacle glasses to correct vision

Study groups in NCT01236742
Study group	Role	What they receive
single-vision glasses and ortho-k lenses	Experimental	Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months Receives: Device: ortho-k lenses; Device: single-vision glasses
ortho-k lenses	Active comparator	Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group Receives: Device: ortho-k lenses
single-vision glasses	Other	Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group Receives: Device: single-vision glasses

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Axial Length
To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects
Measured: Baseline, 7 months, and 14 months after baseline

Secondary outcomes (1)

Incidence of Adverse Effects
The observation of serious and non-serious adverse events in the 14 months of study period
Measured: 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Jun 2013

First posted9 Nov 2010 (estimated)
Study startJul 2010
Primary completionJan 2013
Study completionJun 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 (4)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: Outcomes assessor
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01236742
Sponsor's protocol ID: H-ZG50-1
Acronym: DOEE1
Status last verified: Nov 2017
First submitted: 8 Nov 2010
Last updated: 18 Dec 2017
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 15875367
Walline 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 19416935
Cho P, Cheung SW. Discontinuation of orthokeratology on eyeball elongation (DOEE). Cont Lens Anterior Eye. 2017 Apr;40(2):82-87. doi: 10.1016/j.clae.2016.12.002. Epub 2016 Dec 27.
PubMed 28038841
Lawrenson 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (1) Discontinuation of Lens Wear in Existing Ortho-k Children
ClinicalTrials.gov ID: NCT01236742
Acronym / sponsor ID: DOEE1 / H-ZG50-1
Conditions: Myopia
Keywords: children, corneal reshaping, myopia, myopia progression, orthokeratology
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Collaborators: Menicon Co., Ltd.
Study start: Jul 2010
Primary completion: Jan 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 9 Nov 2010 (estimated)
Results: Posted 8 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
single-vision glasses and ortho-k lenses	Experimental	Device: ortho-k lenses, Device: single-vision glassesChildren who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months
ortho-k lenses	Active comparator	Device: ortho-k lensesChildren who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group
single-vision glasses	Other	Device: single-vision glassesChildren who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group

Who may qualify

Ages: 8 to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Age 8-14 years old (inclusive)
Subjects who have completed the ROMIO, TO-SEE or HM-PRO studies at The Hong Kong Polytechnic University
Willingness to be randomized into groups (for ortho-k subjects)
Availability for follow-up for at least 14 months

Key exclusion criteria (5 listed)

Non-compliance to the follow up schedule
Non-compliance to the assigned optical correction (i.e. single-vision glasses or ortho-k lenses)
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)

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 lensesAlso: orthokeratology, corneal reshaping therapy, Menicon Z Night lenses, Menicon Z Night Toric lensesnightly wear of orthokeratology lenses to correct vision	Device	ortho-k lenses, single-vision glasses and ortho-k lenses
single-vision glassesAlso: CR-39 lensesdaily wear of spectacle glasses to correct vision	Device	single-vision glasses, single-vision glasses and ortho-k lenses

Primary outcome

Change in Axial Length
Time frame: Baseline, 7 months, and 14 months after baseline
To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects

1 secondary outcome

Incidence of Adverse Effects
Time frame: 14 months

Results and safety

Results posted to the registry on 8 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single-vision Glasses and Ortho-k Lenses	18	15
Ortho-k Lenses	19	16
Single-vision Glasses	16	13

Primary outcome: Change in Axial Length

Time frame: Baseline, 7 months, and 14 months after baseline. Mean (Standard Deviation). Unit: mm

Measure	Single-vision Glasses and Ortho-k Lenses n = 15	Ortho-k Lenses n = 16	Single-vision Glasses n = 13
Phase I (first 7 months)	0.153 (0.021)	0.087 (0.020)	0.082 (0.022)
Phase II (last 7 months)	0.059 (0.014)	0.068 (0.013)	0.064 (0.015)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse effect data were collected within 2 months after completion of the study for subjects on ortho-k. The subjects were asked to return the contact lenses upon completion of the study and were dismissed once their refractive error and corneal shape were stabilized after cessation of ortho-k treatment. The time required was less than 2 months for all subjects.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-vision Glasses and Ortho-k Lenses	0 of 18 (0%)	1 of 18 (5.6%)	Not reported
Ortho-k Lenses	0 of 19 (0%)	0 of 19 (0%)	Not reported
Single-vision Glasses	0 of 16 (0%)	0 of 16 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
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 28038841Cho P, Cheung SW. Discontinuation of orthokeratology on eyeball elongation (DOEE). Cont Lens Anterior Eye. 2017 Apr;40(2):82-87. doi: 10.1016/j.clae.2016.12.002. Epub 2016 Dec 27.
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.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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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 single-vision glasses 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 4 inclusion and 5 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 18 Dec 2017. 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 8 Nov 2017). 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 Length (time frame: Baseline, 7 months, and 14 months after baseline). 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 NCT01236742, which also lists 4 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 18 Dec 2017.