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

Wenzhou Medical University

Status: Unknown

Conditions: Myopia

Treatments: Other: Plum-blossom Needle; Drug: Tropicamide Eye Drops

Study type: Interventional

Funder types: Other

Identifiers

NCT03097198

2016ZB080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 8 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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98 participants in 2 patient groups

PbN-TED

Experimental group

Description:

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.

Treatment:

Other: Plum-blossom Needle

Drug: Tropicamide Eye Drops

TED-PbN

Experimental group

Description:

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.

Treatment:

Other: Plum-blossom Needle

Drug: Tropicamide Eye Drops