Myopic ProgressionNCT05192824
Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality
A study testing Orthokeratology lens in people with Myopic Progression, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
This study was aimed to evaluate the effects of different Orthokeratology，including the size of central optical zone and the height of peripheral reverse curve, on myopia control and visual quality. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopic Progression
- What is being tested?
- Orthokeratology lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2021to 31 Dec 2025
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Myopia: between -1.00D and 4.00D in both eyes
- Astigmatism: <1.5D for with-the-rule astigmatism, <1.00D for the against-the-rule astigmatism
- Visual acuity: the best corrected vision acuity(BCVA)≥20/20 in both eyes
- Subjects that volunteer to participate in the clinical trial and sign informed consent
Who cannot join
- Contraindications of wearing Ortho-K.
- Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
- Any type of strabismus or amblyopia
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020
Shuxian Zhang, +8618630996574, xindewo2006@163.com
About this study
This study was aimed to evaluate the effects of different Orthokeratology，including the size of central optical zone and the height of peripheral reverse curve, on myopia control and visual quality.
Read the detailed description
This study was aimed to evaluate the effects of different Orthokeratology on myopia control and visual quality. The different optical zone of Orthokeratology lens was divided into 4 groups, ranged from 5.5 mm to 6 mm. And the control group subjects with the single glasses was included. The effectiveness of Orthokeratology was measured by axial length progression. The visual quality of subjects was evaluated by a questionnaire, contrast sensitivity and wavefront aberration.
- Conditions
- Myopic Progression
- Being tested
- Orthokeratology lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthokeratology lensDevice
Also called Ortho-K
The intervention was according to the design of different optical zone and peripheral reverse curve
| Study group | Role | What they receive |
|---|---|---|
| Single-vision glasses | No intervention | Subjects wearing single-vision glasses CR-39 |
| Orthokeratology lenses group 1 | Experimental | Subjects wearing orthokeratology lenses of 5mm optical zone. Receives: Device: Orthokeratology lens |
| Orthokeratology lenses group 2 | Experimental | Subjects wearing orthokeratology lenses of 5.5mm optical zone. Receives: Device: Orthokeratology lens |
| Orthokeratology lenses group 3 | Experimental | Subjects wearing orthokeratology lenses of 6mm optical zone. Receives: Device: Orthokeratology lens |
| Orthokeratology lenses group 4 | Experimental | Subjects wearing orthokeratology lenses of 6mm optical zone and the increased height of peripheral reverse curve. Receives: Device: Orthokeratology lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in axial length in 2 years
The axial length was measured by AL-scan
Measured: Every 6 months for a period 2 years
Changes in Cycloplegic subjective refraction in 2 years
The cycloplegic subjective refraction was evaluated by optometrist
Measured: Every 6 months for a period 2 years
Secondary outcomes (9)
Change in visual questionnaire as compared to baseline（Postoperative 6 months, 12 months, 18 months and 24 months）
The symptoms score measured by a visual questionnaire, each symptom was evaluated on a scale of 0 to 10.
Measured: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
Ocular aberration measured by Zeiss i. Profiler Plus aberrometer
Measured: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in contrast sensitivity as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Contrast sensitivity measured by Stereo optical 6500
Measured: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in choroidal thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software
Measured: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) customized software
Measured: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in corneal biomechanics parameters (SSI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Corneal response parameters(SSI) was evaluated by Corvis ST.
Measured: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in peripheral refraction as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Peripheral refraction measured by multispectral refraction topography
Measured: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in corneal surface regularity index (SRI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
The corneal surface regularity index (SRI) was measured by Corneal Topography.
Measured: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in corneal surface asymmetry index (SAI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
The corneal surface asymmetry index (SAI) was measured by Corneal Topography.
Measured: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start10 Dec 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuxian zhang, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192824
- Sponsor's protocol ID
- TianjinEH-Orthokeratology lens
- Status last verified
- Dec 2021
- First submitted
- 19 Nov 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He M, Du Y, Liu Q, Ren C, Liu J, Wang Q, Li L, Yu J. Effects of orthokeratology on the progression of low to moderate myopia in Chinese children. BMC Ophthalmol. 2016 Jul 27;16:126. doi: 10.1186/s12886-016-0302-5.
PubMed 27464993Huang J, Wen D, Wang Q, McAlinden C, Flitcroft I, Chen H, Saw SM, Chen H, Bao F, Zhao Y, Hu L, Li X, Gao R, Lu W, Du Y, Jinag Z, Yu A, Lian H, Jiang Q, Yu Y, Qu J. Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123(4):697-708. doi: 10.1016/j.ophtha.2015.11.010. Epub 2016 Jan 27.
PubMed 26826749Hu Y, Wen C, Li Z, Zhao W, Ding X, Yang X. Areal summed corneal power shift is an important determinant for axial length elongation in myopic children treated with overnight orthokeratology. Br J Ophthalmol. 2019 Nov;103(11):1571-1575. doi: 10.1136/bjophthalmol-2018-312933. Epub 2019 Jan 31.
PubMed 30705043Paune J, Fonts S, Rodriguez L, Queiros A. The Role of Back Optic Zone Diameter in Myopia Control with Orthokeratology Lenses. J Clin Med. 2021 Jan 18;10(2):336. doi: 10.3390/jcm10020336.
PubMed 33477514Gifford P, Tran M, Priestley C, Maseedupally V, Kang P. Reducing treatment zone diameter in orthokeratology and its effect on peripheral ocular refraction. Cont Lens Anterior Eye. 2020 Feb;43(1):54-59. doi: 10.1016/j.clae.2019.11.006. Epub 2019 Nov 24.
PubMed 31776061
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality
- ClinicalTrials.gov ID
- NCT05192824
- Acronym / sponsor ID
- TianjinEH-Orthokeratology lens
- Conditions
- Myopic Progression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jan 2022 (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.
This study was aimed to evaluate the effects of different Orthokeratology，including the size of central optical zone and the height of peripheral reverse curve, on myopia control and visual quality.
Detailed description
This study was aimed to evaluate the effects of different Orthokeratology on myopia control and visual quality. The different optical zone of Orthokeratology lens was divided into 4 groups, ranged from 5.5 mm to 6 mm. And the control group subjects with the single glasses was included. The effectiveness of Orthokeratology was measured by axial length progression. The visual quality of subjects was evaluated by a questionnaire, contrast sensitivity and wavefront aberration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single-vision glasses | No intervention | –Subjects wearing single-vision glasses CR-39 |
| Orthokeratology lenses group 1 | Experimental | Device: Orthokeratology lensSubjects wearing orthokeratology lenses of 5mm optical zone. |
| Orthokeratology lenses group 2 | Experimental | Device: Orthokeratology lensSubjects wearing orthokeratology lenses of 5.5mm optical zone. |
| Orthokeratology lenses group 3 | Experimental | Device: Orthokeratology lensSubjects wearing orthokeratology lenses of 6mm optical zone. |
| Orthokeratology lenses group 4 | Experimental | Device: Orthokeratology lensSubjects wearing orthokeratology lenses of 6mm optical zone and the increased height of peripheral reverse curve. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Myopia: between -1.00D and 4.00D in both eyes
- Astigmatism: <1.5D for with-the-rule astigmatism, <1.00D for the against-the-rule astigmatism
- Visual acuity: the best corrected vision acuity(BCVA)≥20/20 in both eyes
- Subjects that volunteer to participate in the clinical trial and sign informed consent
Key exclusion criteria (5 listed)
- Contraindications of wearing Ortho-K.
- Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
- Any type of strabismus or amblyopia
- 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)
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 lensAlso: Ortho-KThe intervention was according to the design of different optical zone and peripheral reverse curve | Device | Orthokeratology lenses group 1, Orthokeratology lenses group 2, Orthokeratology lenses group 3, Orthokeratology lenses group 4 |
Primary outcome
Changes in axial length in 2 years
Time frame: Every 6 months for a period 2 years
The axial length was measured by AL-scan
Changes in Cycloplegic subjective refraction in 2 years
Time frame: Every 6 months for a period 2 years
The cycloplegic subjective refraction was evaluated by optometrist
9 secondary outcomes
Change in visual questionnaire as compared to baseline（Postoperative 6 months, 12 months, 18 months and 24 months）
Time frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
Time frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in contrast sensitivity as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Time frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in choroidal thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Time frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Time frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in corneal biomechanics parameters (SSI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Time frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in peripheral refraction as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Time frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in corneal surface regularity index (SRI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Time frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in corneal surface asymmetry index (SAI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Time frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Background: PubMed 27464993He M, Du Y, Liu Q, Ren C, Liu J, Wang Q, Li L, Yu J. Effects of orthokeratology on the progression of low to moderate myopia in Chinese children. BMC Ophthalmol. 2016 Jul 27;16:126. doi: 10.1186/s12886-016-0302-5.
- Background: PubMed 26826749Huang J, Wen D, Wang Q, McAlinden C, Flitcroft I, Chen H, Saw SM, Chen H, Bao F, Zhao Y, Hu L, Li X, Gao R, Lu W, Du Y, Jinag Z, Yu A, Lian H, Jiang Q, Yu Y, Qu J. Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123(4):697-708. doi: 10.1016/j.ophtha.2015.11.010. Epub 2016 Jan 27.
- Background: PubMed 30705043Hu Y, Wen C, Li Z, Zhao W, Ding X, Yang X. Areal summed corneal power shift is an important determinant for axial length elongation in myopic children treated with overnight orthokeratology. Br J Ophthalmol. 2019 Nov;103(11):1571-1575. doi: 10.1136/bjophthalmol-2018-312933. Epub 2019 Jan 31.
- Background: PubMed 33477514Paune J, Fonts S, Rodriguez L, Queiros A. The Role of Back Optic Zone Diameter in Myopia Control with Orthokeratology Lenses. J Clin Med. 2021 Jan 18;10(2):336. doi: 10.3390/jcm10020336.
- Background: PubMed 31776061Gifford P, Tran M, Priestley C, Maseedupally V, Kang P. Reducing treatment zone diameter in orthokeratology and its effect on peripheral ocular refraction. Cont Lens Anterior Eye. 2020 Feb;43(1):54-59. doi: 10.1016/j.clae.2019.11.006. Epub 2019 Nov 24.
- Individual participant dataSharing planned: No
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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?
A study testing Orthokeratology lens in people with Myopic Progression, run by Tianjin Eye Hospital 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: status not confirmed, as of the sponsor's last update on 14 Jan 2022. 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 Shuxian Zhang, MD (+8618630996574, xindewo2006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in axial length in 2 years (time frame: Every 6 months for a period 2 years). The study lists 2 primary outcomes in all. 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 NCT05192824, which also lists 5 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 14 Jan 2022.