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Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia

Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia: A Cross-over Single-blind Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03097198
Enrollment
98
Registered
2017-03-31
Start date
2016-12-31
Completion date
2018-12-31
Last updated
2017-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Juvenile, Traditional Chinese Medicine, Plum-blossom needle

Brief 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.

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.

Interventions

OTHERPlum-blossom Needle

* 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.

DRUGTropicamide Eye Drops

Instill one drop in both eyes every night before bed.

Sponsors

Wenzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes of vision acuityEvery 30 days for 150 daysInternational Standard Visual Acuity Chart
Changes of cycloplegic refractive errorsEvery 30 days for 150 daysMeasured using subjective refraction

Secondary

MeasureTime frame
Changes of accommodation responsesEvery 30 days for 150 days
Changes of accommodation facilityEvery 30 days for 150 days
Changes of ciliary body thicknessEvery 30 days for 150 days
Changes of axial lengthEvery 30 days for 150 days

Countries

China

Contacts

Primary ContactLewei Tang, Doctor
zhizhezhiwei@163.com+86 15869627364

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026