MyopiaNCT03097198
Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia
A study testing Plum-blossom Needle and Tropicamide Eye Drops in people with Myopia, run by Wenzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine whether plum-blossom needle is effective in the treatment of juvenile myopia and compare the efficacy with Tropicamide Eye Drops. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Myopia
- What is being tested?
- Plum-blossom Needle and Tropicamide Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2018
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The result of retinoscopy is myopic refractive error, near visual acuity and other visual functions must be normal
- Distance visual acuity can be corrected to normal using negative spherical or cylindrical lenses
- Myopia diopter spherical lenses must be ≤-3.00 D which measured under cycloplegia
- Subjects must be between 8 and 20 years of age
Who cannot join
- Diopter spherical lenses be >-3.00 D , or uncorrected distance visual acuity <0.1, or pathologic myopia with eye complications
- Diopter spherical lense ≥1.50 D or cylindrical lenses ≥1.00 D, as measured under cycloplegia
- The affected eyes have other diseases which affect the determination of acupuncture efficacy
- Subjects with serious systemic diseases, such as cerebrovascular, liver, kidney, hematopoietic system, and psychiatric diseases
- Longterm use of other related drugs or treatments, which have not been terminated
- Parents or subjects refuse to participate this trial
- Participating other ongoing clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Lewei Tang, Doctor, +86 15869627364, zhizhezhiwei@163.com
About this study
Official title: Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia: A Cross-over Single-blind Randomized Study
The purpose of this study is to determine whether plum-blossom needle is effective in the treatment of juvenile myopia and compare the efficacy with Tropicamide Eye Drops.
Read the detailed description
Plum-blossom needle is a historical treatment technology of Traditional Chinese Medicine, and has been applied to ophthalmic diseases, such as myopia and glaucoma, for nearly one hundred years.
- Conditions
- Myopia
- Being tested
- Plum-blossom Needle, Tropicamide Eye Drops
- Keywords
- Juvenile, Traditional Chinese Medicine, Plum-blossom needle
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plum-blossom NeedleOther
Also called Double head dermal needles (HWATO, China)
- acupoint selection: Zhengguang 1, Zhengguang 2, GB20, GV14, LI4.
- plum-blossom needle manipulation methods: After the skin has been wiped with 75 % alcohol, plum-blossom needles will be tapped perpendicularly on the skin at the selected acupoints with wrist force and then lifted immediately. Each point will be tapped repeatedly for 20 to 50 times and both sides of cervical vertebra and temporal region, Suprao-infraorbital margin will be tapped repeatedly. Acupuncturists should tap the points gently to make patients feel only a little pain and stop when the skin gets flushed but is not bleeding.
Tropicamide Eye DropsDrug
Also called 6ml:30mg(0.5%)（FREDA, China）
Instill one drop in both eyes every night before bed.
| Study group | Role | What they receive |
|---|---|---|
| PbN-TED | Experimental | Treated with plum-blossom needle first for 10 times during 20 days, followed with a one-month wash-out period and a 10-day period with Tropicamide Eye Drops. Receives: Other: Plum-blossom Needle; Drug: Tropicamide Eye Drops |
| TED-PbN | Experimental | Treated with Tropicamide Eye Drops for 10 days first, followed with a one-month wash-out period and 10 times of plum-blossom needle treatment for 20 days. Receives: Other: Plum-blossom Needle; Drug: Tropicamide Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of vision acuity
International Standard Visual Acuity Chart
Measured: Every 30 days for 150 days
Changes of cycloplegic refractive errors
Measured using subjective refraction
Measured: Every 30 days for 150 days
Secondary outcomes (4)
Changes of accommodation responses
Measured: Every 30 days for 150 days
Changes of accommodation facility
Measured: Every 30 days for 150 days
Changes of ciliary body thickness
Measured: Every 30 days for 150 days
Changes of axial length
Measured: Every 30 days for 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startDec 2016
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Lewei, Wenzhou Medical University
- Investigators
- Yuanbo Liang, Doctor, Study director, Clinical&Epidemiological Eye Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097198
- Sponsor's protocol ID
- 2016ZB080
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD sharing plan is undecided yet.
Publications
Chen L, Liang Y, Xu M, Zheng J, Yu H, Tang L. Effect of plum-blossom needling versus tropicamide eye drops on adolescent myopia: protocol for a randomized crossover trial. J Tradit Chin Med. 2020 Apr;40(2):333-339.
PubMed 32242400
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia: A Cross-over Single-blind Randomized Study
- ClinicalTrials.gov ID
- NCT03097198
- Acronym / sponsor ID
- 2016ZB080
- Conditions
- Myopia
- Keywords
- Juvenile, Traditional Chinese Medicine, Plum-blossom needle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 31 Mar 2017 (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.
The purpose of this study is to determine whether plum-blossom needle is effective in the treatment of juvenile myopia and compare the efficacy with Tropicamide Eye Drops.
Detailed description
Plum-blossom needle is a historical treatment technology of Traditional Chinese Medicine, and has been applied to ophthalmic diseases, such as myopia and glaucoma, for nearly one hundred years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PbN-TED | Experimental | Other: Plum-blossom Needle, Drug: Tropicamide Eye DropsTreated with plum-blossom needle first for 10 times during 20 days, followed with a one-month wash-out period and a 10-day period with Tropicamide Eye Drops. |
| TED-PbN | Experimental | Other: Plum-blossom Needle, Drug: Tropicamide Eye DropsTreated with Tropicamide Eye Drops for 10 days first, followed with a one-month wash-out period and 10 times of plum-blossom needle treatment for 20 days. |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The result of retinoscopy is myopic refractive error, near visual acuity and other visual functions must be normal
- Distance visual acuity can be corrected to normal using negative spherical or cylindrical lenses
- Myopia diopter spherical lenses must be ≤-3.00 D which measured under cycloplegia
- Subjects must be between 8 and 20 years of age
Key exclusion criteria (7 listed)
- Diopter spherical lenses be >-3.00 D , or uncorrected distance visual acuity <0.1, or pathologic myopia with eye complications
- Diopter spherical lense ≥1.50 D or cylindrical lenses ≥1.00 D, as measured under cycloplegia
- The affected eyes have other diseases which affect the determination of acupuncture efficacy
- Subjects with serious systemic diseases, such as cerebrovascular, liver, kidney, hematopoietic system, and psychiatric diseases
- Longterm use of other related drugs or treatments, which have not been terminated
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 |
|---|---|---|
| Plum-blossom NeedleAlso: Double head dermal needles (HWATO, China)* acupoint selection: Zhengguang 1, Zhengguang 2, GB20, GV14, LI4. * plum-blossom needle manipulation methods: After the skin has been wiped with 75 % alcohol, plum-blossom needles will be tapped perpendicularly on the skin at the selected acupoints with wrist force and then lifted immediately. Each point will be tapped repeatedly for 20 to 50 times and both sides of cervical vertebra and temporal region, Suprao-infraorbital margin will be tapped repeatedly. Acupuncturists should tap the points gently to make patients feel only a little pain and stop when the skin gets flushed but is not bleeding. | Other | PbN-TED, TED-PbN |
| Tropicamide Eye DropsAlso: 6ml:30mg(0.5%)（FREDA, China）Instill one drop in both eyes every night before bed. | Drug | PbN-TED, TED-PbN |
Primary outcome
Changes of vision acuity
Time frame: Every 30 days for 150 days
International Standard Visual Acuity Chart
Changes of cycloplegic refractive errors
Time frame: Every 30 days for 150 days
Measured using subjective refraction
4 secondary outcomes
Changes of accommodation responses
Time frame: Every 30 days for 150 days
Changes of accommodation facility
Time frame: Every 30 days for 150 days
Changes of ciliary body thickness
Time frame: Every 30 days for 150 days
Changes of axial length
Time frame: Every 30 days for 150 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Derived from this study: PubMed 32242400Chen L, Liang Y, Xu M, Zheng J, Yu H, Tang L. Effect of plum-blossom needling versus tropicamide eye drops on adolescent myopia: protocol for a randomized crossover trial. J Tradit Chin Med. 2020 Apr;40(2):333-339.
- Individual participant dataSharing planned: Undecided. The IPD sharing plan is undecided yet.
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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.
Yuanbo Liang, Doctor study director
Clinical&Epidemiological Eye Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plum-blossom Needle and Tropicamide Eye Drops in people with Myopia, run by Wenzhou Medical 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 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: status not confirmed, as of the sponsor's last update on 31 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lewei Tang, Doctor (+86 15869627364, zhizhezhiwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of vision acuity (time frame: Every 30 days for 150 days). 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 NCT03097198, which also lists 1 linked publication.
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 31 Mar 2017.