Myopic ProgressionNCT02643342
A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye
A study testing Orthokeratology in people with Myopic Progression, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopic Progression
- What is being tested?
- Orthokeratology
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2016to 3 Aug 2019
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 to 10 years old
- Myopia: between 0.50 D and 4.00 D in both eyes
- Astigmatism: <1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
- Anisometropia: ≤ 1.50 D
- Symmetrical corneal topography with corneal toricity <2.00 D in both eyes
- Agree for randomization
Who cannot join
- Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
- Any type of strabismus or amblyopia
- Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
- Rigid contact lenses (including orthokeratology lenses) experience
- Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
- Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
- Poor compliance for lens wear or follow-up
Trial locations and contacts
1 site in 1 country.
About this study
This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control.
- Conditions
- Myopic Progression
- Being tested
- Orthokeratology
- Keywords
- myopia control, orthokeratology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthokeratologyDevice
Also called ortho-k
| Study group | Role | What they receive |
|---|---|---|
| Single-vision glasses | No intervention | Subjects wearing single-vision glasses CR-39 of refractive index 1.56. |
| Orthokeratology with normal compression factor | Sham comparator | Subjects wearing orthokeratology lenses of normal compression factor about 0.50-0.75D. Receives: Device: Orthokeratology |
| Orthokeratology with increased compression factor | Active comparator | Subjects wearing orthokeratology lenses of increased compression factor about 1.50-1.75D. Receives: Device: Orthokeratology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
axial progression of the eyeball
Measured: every 6 monthly in 2 years
Secondary outcomes (4)
Ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer
ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer
Measured: every 6 monthly in 2 years
Corneal biomechanics (corneal response using ocular response)
corneal response using ocular response
Measured: every 6 monthly in 2 years
Accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer
accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer using different accommodation targets
Measured: every 6 monthly in 2 years
Choroidal thickness captured by Optical Coherent Tomographer (OCT)
choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software
Measured: every 6 monthly in 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study start18 Jun 2016
- Primary completion3 Aug 2019
- Study completion3 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Myopic ProgressionStudies 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Menicon Co., Ltd., 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
- NCT02643342
- Sponsor's protocol ID
- HSEARS20150909002
- Status last verified
- Feb 2020
- First submitted
- 28 Dec 2015
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lam CS, Lam CH, Cheng SC, Chan LY. Prevalence of myopia among Hong Kong Chinese schoolchildren: changes over two decades. Ophthalmic Physiol Opt. 2012 Jan;32(1):17-24. doi: 10.1111/j.1475-1313.2011.00886.x.
PubMed 22150587Cho 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 15875367Cho 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 22969068Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527.
PubMed 24003088Gonzalez-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 18434845Wolffsohn JS, Safeen S, Shah S, Laiquzzaman M. Changes of corneal biomechanics with keratoconus. Cornea. 2012 Aug;31(8):849-54. doi: 10.1097/ICO.0b013e318243e42d.
PubMed 22495031Tse DY, Lam CS, Guggenheim JA, Lam C, Li KK, Liu Q, To CH. Simultaneous defocus integration during refractive development. Invest Ophthalmol Vis Sci. 2007 Dec;48(12):5352-9. doi: 10.1167/iovs.07-0383.
PubMed 18055781Chan B, Cho P, Mountford J. The validity of the Jessen formula in overnight orthokeratology: a retrospective study. Ophthalmic Physiol Opt. 2008 May;28(3):265-8. doi: 10.1111/j.1475-1313.2008.00545.x.
PubMed 18426426Wan K, Lau JK, Cheung SW, Cho P. Orthokeratology with increased compression factor (OKIC): study design and preliminary results. BMJ Open Ophthalmol. 2020 May 4;5(1):e000345. doi: 10.1136/bmjophth-2019-000345. eCollection 2020.
PubMed 32420450
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye
- ClinicalTrials.gov ID
- NCT02643342
- Acronym / sponsor ID
- HSEARS20150909002
- Conditions
- Myopic Progression
- Keywords
- myopia control, orthokeratology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Menicon Co., Ltd., Queensland University of Technology, Aston University
- Study start
- 18 Jun 2016 (actual)
- Primary completion
- 3 Aug 2019 (actual)
- Study completion
- 3 Aug 2019 (actual)
- First posted
- 31 Dec 2015 (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.
This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control.
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 | No intervention | –Subjects wearing single-vision glasses CR-39 of refractive index 1.56. |
| Orthokeratology with normal compression factor | Sham comparator | Device: OrthokeratologySubjects wearing orthokeratology lenses of normal compression factor about 0.50-0.75D. |
| Orthokeratology with increased compression factor | Active comparator | Device: OrthokeratologySubjects wearing orthokeratology lenses of increased compression factor about 1.50-1.75D. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 6 to 10 years old
- Myopia: between 0.50 D and 4.00 D in both eyes
- Astigmatism: <1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
- Anisometropia: ≤ 1.50 D
- Symmetrical corneal topography with corneal toricity <2.00 D in both eyes
Key exclusion criteria (7 listed)
- Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
- Any type of strabismus or amblyopia
- Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
- Rigid contact lenses (including orthokeratology lenses) experience
- Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
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 |
|---|---|---|
| OrthokeratologyAlso: ortho-k | Device | Orthokeratology with increased compression factor, Orthokeratology with normal compression factor |
Primary outcome
Axial length
Time frame: every 6 monthly in 2 years
axial progression of the eyeball
4 secondary outcomes
Ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer
Time frame: every 6 monthly in 2 years
Corneal biomechanics (corneal response using ocular response)
Time frame: every 6 monthly in 2 years
Accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer
Time frame: every 6 monthly in 2 years
Choroidal thickness captured by Optical Coherent Tomographer (OCT)
Time frame: every 6 monthly in 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 30 Jul 2020.
- Background: PubMed 22150587Lam CS, Lam CH, Cheng SC, Chan LY. Prevalence of myopia among Hong Kong Chinese schoolchildren: changes over two decades. Ophthalmic Physiol Opt. 2012 Jan;32(1):17-24. doi: 10.1111/j.1475-1313.2011.00886.x.
- 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 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.
- Background: PubMed 24003088Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527.
- 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.
- Background: PubMed 22495031Wolffsohn JS, Safeen S, Shah S, Laiquzzaman M. Changes of corneal biomechanics with keratoconus. Cornea. 2012 Aug;31(8):849-54. doi: 10.1097/ICO.0b013e318243e42d.
- Background: PubMed 18055781Tse DY, Lam CS, Guggenheim JA, Lam C, Li KK, Liu Q, To CH. Simultaneous defocus integration during refractive development. Invest Ophthalmol Vis Sci. 2007 Dec;48(12):5352-9. doi: 10.1167/iovs.07-0383.
- Background: PubMed 18426426Chan B, Cho P, Mountford J. The validity of the Jessen formula in overnight orthokeratology: a retrospective study. Ophthalmic Physiol Opt. 2008 May;28(3):265-8. doi: 10.1111/j.1475-1313.2008.00545.x.
- Derived from this study: PubMed 32420450Wan K, Lau JK, Cheung SW, Cho P. Orthokeratology with increased compression factor (OKIC): study design and preliminary results. BMJ Open Ophthalmol. 2020 May 4;5(1):e000345. doi: 10.1136/bmjophth-2019-000345. eCollection 2020.
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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 in people with Myopic Progression, 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 7 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 30 Jul 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. Some participants in this study may receive a placebo. 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?
Axial length (time frame: every 6 monthly in 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 NCT02643342, which also lists 9 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 30 Jul 2020.