MyopiaNCT00978679
Peripheral Optics in Myopia and Orthokeratology
A study testing Orthokeratology lenses and Spectacles in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The primary objective of the current study is to investigate changes in peripheral refraction and aberration in children wearing orthokeratology lenses and single-vision spectacles. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Orthokeratology lenses and Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Dec 2015
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Myopia (refractive sphere): > 0.50D and ≤ 6.00D
- Astigmatism: with-the-rule astigmatism (axes 180 +/- 30) ≤ 1.50D; astigmatism of other axes ≤ 0.50D
- Spherical equivalent (SE): > 0.50D and ≤ 6.75D (myopia)
- Best corrected monocular visual acuity: equal to or better than 6/7.5 in Snellen scale
- 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 myopic control treatment (e.g. refractive therapy or progressive 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, 000000
About this study
Official title: Peripheral Refraction and Aberration in Myopic Progression and Myopic Control
The primary objective of the current study is to investigate changes in peripheral refraction and aberration in children wearing orthokeratology lenses and single-vision spectacles.
Read the detailed description
Apart from being effective in reducing low to moderate myopia, orthokeratology has been shown to have potential in retarding myopic progression. The central cornea is flattened and peripheral optics altered in orthokeratology and it has been suggested that orthokeratology slows myopic progression through the alteration of peripheral optics. The aim of the current study is to investigate the changes in peripheral refraction and aberration in children wearing orthokeratology (study group) and single-vision spectacles (control group).
- Conditions
- Myopia
- Being tested
- Orthokeratology lenses, Spectacles
- Keywords
- Children, Peripheral refraction, Aberration, Eyeball length, Myopic control, Myopia, Corneal reshaping, 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 Menicon Z Night Lens 2, Menicon Z Night Lens 2 Toric
Nightly use of orthokeratology lenses to correct the refractive errors
SpectaclesDevice
Also called Glasses, Eyeglasses
Daily use of single vision lenses to correct refractive errors
| Study group | Role | What they receive |
|---|---|---|
| Orthokeratology | Experimental | Myopic children wearing orthokeratology at night will be the study group Receives: Device: Orthokeratology lenses |
| Others | Other | Myopic children wearing single-vision spectacles in the daytime will serve as control group Receives: Device: Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length
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 posted17 Sep 2009 (estimated)
- Study startMar 2008
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 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, School of Optometry, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978679
- Sponsor's protocol ID
- G-RGVM
- Status last verified
- Feb 2016
- First submitted
- 16 Sep 2009
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mathur A, Atchison DA. Effect of orthokeratology on peripheral aberrations of the eye. Optom Vis Sci. 2009 May;86(5):E476-84. doi: 10.1097/OPX.0b013e31819fa5aa.
PubMed 19342979Cho 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 19416935Charman WN, Mountford J, Atchison DA, Markwell EL. Peripheral refraction in orthokeratology patients. Optom Vis Sci. 2006 Sep;83(9):641-8. doi: 10.1097/01.opx.0000232840.66716.af.
PubMed 16971842
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Refraction and Aberration in Myopic Progression and Myopic Control
- ClinicalTrials.gov ID
- NCT00978679
- Acronym / sponsor ID
- G-RGVM
- Conditions
- Myopia
- Keywords
- Children, Peripheral refraction, Aberration, Eyeball length, Myopic control, Myopia, Corneal reshaping, Orthokeratology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Menicon Co., Ltd.
- Study start
- Mar 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 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 primary objective of the current study is to investigate changes in peripheral refraction and aberration in children wearing orthokeratology lenses and single-vision spectacles.
Detailed description
Apart from being effective in reducing low to moderate myopia, orthokeratology has been shown to have potential in retarding myopic progression. The central cornea is flattened and peripheral optics altered in orthokeratology and it has been suggested that orthokeratology slows myopic progression through the alteration of peripheral optics. The aim of the current study is to investigate the changes in peripheral refraction and aberration in children wearing orthokeratology (study group) and single-vision spectacles (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthokeratology | Experimental | Device: Orthokeratology lensesMyopic children wearing orthokeratology at night will be the study group |
| Others | Other | Device: SpectaclesMyopic children wearing single-vision spectacles in the daytime will serve as control group |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Myopia (refractive sphere): > 0.50D and ≤ 6.00D
- Astigmatism: with-the-rule astigmatism (axes 180 +/- 30) ≤ 1.50D; astigmatism of other axes ≤ 0.50D
- Spherical equivalent (SE): > 0.50D and ≤ 6.75D (myopia)
- Best corrected monocular visual acuity: equal to or better than 6/7.5 in Snellen scale
- Willingness to wear contact lenses or spectacles on a daily basis
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 myopic control treatment (e.g. refractive therapy or progressive 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: Menicon Z Night Lens 2, Menicon Z Night Lens 2 ToricNightly use of orthokeratology lenses to correct the refractive errors | Device | Orthokeratology |
| SpectaclesAlso: Glasses, EyeglassesDaily use of single vision lenses to correct refractive errors | Device | Others |
Primary outcome
Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length
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 23 Feb 2016.
- Background: PubMed 19342979Mathur A, Atchison DA. Effect of orthokeratology on peripheral aberrations of the eye. Optom Vis Sci. 2009 May;86(5):E476-84. doi: 10.1097/OPX.0b013e31819fa5aa.
- 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 16971842Charman WN, Mountford J, Atchison DA, Markwell EL. Peripheral refraction in orthokeratology patients. Optom Vis Sci. 2006 Sep;83(9):641-8. doi: 10.1097/01.opx.0000232840.66716.af.
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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
School of Optometry, 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 Spectacles 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 6 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 23 Feb 2016. 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?
Changes in cycloplegic off-axial auto-refraction, aberration and eyeball length (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 NCT00978679, 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 23 Feb 2016.