MyopiaNCT03516357
Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children
An observational study of Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2018to 11 Jan 2022
- Phase
- Observational
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: myopia
Who may be able to join
- 1. subjects were 6-16 years of age; 2.had no other ocular diseases aside from refractive error and no keratoconus (confirmed by pre-treatment corneal topography); 3. had an intraocular pressure (IOP) of <21 mmHg; 4. had an with-the- rule astigmatism (axes 180 ± 30) ≤ 1.50 D; 5.had a best corrected visual acuity（BCVA） ≤0.00 log MAR units in both eyes (Snellen equivalent to 20/20);
Who cannot join
- 1. had binocular vision problems; 2.use medications that might affect refractive development; 3.had history of ortho-k or contact lens wear; 4. Ocular surface diseases and other eye diseases which can cause abnormalities of ocular surface; 5. Patients with histories of ocular injury or surgery; 6. Corneal staining and decentration of lens after wearing Ortho-k.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Jingan, 380 Kangding Road
Zhu Mengjun, MD, 86-21-62565920
Zhu Mengjun, MD
About this study
Official title: Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic
Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children
Read the detailed description
1.The primary objective of the current study is to investigate changes in uncorrected visual acuity, diopter, accommodation, peripheral refraction, IOP, tear film quality, corneal thickness, corneal topography, corneal biomechanical parameters, objective optical quality, corneal and conjunctiva sensitivity and choroidal thickness for children with different diopters after wearing orthokeratology lenses; 2. Through measure long-term changes of these parameters, including corneal topography, axial length, peripheral refraction, objective optical quality and choroidal thickness, to explore occurrence and development regularity of myopia.
- Conditions
- Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| low myopia | -3.00D < spherical equivalent refractive error < -0.50D | |
| moderate myopia | -6.00D < spherical equivalent refractive error ≤ -3.0D | |
| high myopia | spherical equivalent refractive error ≤ -6.0D |
What is being measured
The primary outcome is the main question the study is designed to answer.
axial length measured by IOL-master
measured by IOL-master
Measured: 2 years
Secondary outcomes (10)
accommodation measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
Measured: 2 years
peripheral refraction measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
Measured: 2 years
IOP measured by Corvis-ST
measured by Corvis-ST
Measured: 2 years
corneal thickness measured by Corvis-ST
measured by Corvis-ST
Measured: 2 years
corneal biomechanical parameters measured by Corvis-ST
measured by Corvis-ST
Measured: 2 years
tear film quality measured by Keratography
measured by Keratography
Measured: 2 years
corneal morphological characteristics measured by Optikon 2000 corneal topographer
measured by Optikon 2000 corneal topographer
Measured: 2 years
objective optical quality measured by OQAS visual quality analyzing system
measured by OQAS visual quality analyzing system
Measured: 2 years
corneal and conjunctiva sensitivity measured by Cochet-Bonnet
measured by Cochet-Bonnet
Measured: 2 years
choroidal thickness measured by ocular coherence tomography
measured by ocular coherence tomography
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 posted4 May 2018
- Study start11 Jan 2018
- Primary completion11 Jan 2022 (estimated)
- Study completion11 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516357
- Sponsor's protocol ID
- YFZX2017002
- Status last verified
- Nov 2017
- First submitted
- 12 Apr 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic
- ClinicalTrials.gov ID
- NCT03516357
- Acronym / sponsor ID
- YFZX2017002
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 11 Jan 2022 (estimated)
- Study completion
- 11 Jan 2022 (estimated)
- First posted
- 4 May 2018 (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.
Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children
Detailed description
1.The primary objective of the current study is to investigate changes in uncorrected visual acuity, diopter, accommodation, peripheral refraction, IOP, tear film quality, corneal thickness, corneal topography, corneal biomechanical parameters, objective optical quality, corneal and conjunctiva sensitivity and choroidal thickness for children with different diopters after wearing orthokeratology lenses; 2. Through measure long-term changes of these parameters, including corneal topography, axial length, peripheral refraction, objective optical quality and choroidal thickness, to explore occurrence and development regularity of myopia.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low myopia | – | –-3.00D < spherical equivalent refractive error < -0.50D |
| moderate myopia | – | –-6.00D < spherical equivalent refractive error ≤ -3.0D |
| high myopia | – | –spherical equivalent refractive error ≤ -6.0D |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- myopia
Key inclusion criteria (1 listed)
- 1. subjects were 6-16 years of age; 2.had no other ocular diseases aside from refractive error and no keratoconus (confirmed by pre-treatment corneal topography); 3. had an intraocular pressure (IOP) of <21 mmHg; 4. had an with-the- rule astigmatism (axes 180 ± 30) ≤ 1.50 D; 5.had a best corrected visual acuity（BCVA） ≤0.00 log MAR units in both eyes (Snellen equivalent to 20/20);
Key exclusion criteria (1 listed)
- 1. had binocular vision problems; 2.use medications that might affect refractive development; 3.had history of ortho-k or contact lens wear; 4. Ocular surface diseases and other eye diseases which can cause abnormalities of ocular surface; 5. Patients with histories of ocular injury or surgery; 6. Corneal staining and decentration of lens after wearing 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.
Primary outcome
axial length measured by IOL-master
Time frame: 2 years
measured by IOL-master
10 secondary outcomes
accommodation measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
Time frame: 2 years
peripheral refraction measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
Time frame: 2 years
IOP measured by Corvis-ST
Time frame: 2 years
corneal thickness measured by Corvis-ST
Time frame: 2 years
corneal biomechanical parameters measured by Corvis-ST
Time frame: 2 years
tear film quality measured by Keratography
Time frame: 2 years
corneal morphological characteristics measured by Optikon 2000 corneal topographer
Time frame: 2 years
objective optical quality measured by OQAS visual quality analyzing system
Time frame: 2 years
corneal and conjunctiva sensitivity measured by Cochet-Bonnet
Time frame: 2 years
choroidal thickness measured by ocular coherence tomography
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 4 May 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Shanghai Eye Disease Prevention and Treatment Center 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 1 inclusion and 1 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 4 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhu Mengjun, MD (86-21-62565920, morning5012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
axial length measured by IOL-master (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2018.