the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression

He Eye Hospital

Status: Enrolling

Conditions: Myopia

Treatments: Other: 0.9% sodium chloride; Drug: 0.01% atropine

Study type: Interventional

Funder types: Other

Identifiers

NCT06034366

atropine2023

Details and patient eligibility

About

Near work-induced transient myopia (NITM) is an important factor in permanent myopia (PM) development and progression. Atropine eye drop is beneficial in reducing initial NITM and slowing down myopic progression.Participants were randomly assigned in a 1:1 ratio to receive 0.01% atropine or placebo eye drop once nightly bilaterally for one year. Initial NITM, cycloplegic refraction, axial length (AL), best-corrected visual acuity (BCVA), intraocular pressure (IOP), and pupil diameter will be measured at baseline, 4-week, 12-week, 24-week, 36-week, and 48-week. Visual Function Questionnaire was administered at baseline and each follow-up visit. Adverse events also will be monitored and documented at each subsequent follow-up visit. This study investigates the efficacy of 0.01% atropine in the treatment of NITM and its possible association with the progression of refractive change in Chinese myopic children.

Full description

Myopia is a common condition that develops primarily during childhood and early adulthood when excessive elongation of the eye results in images of distant objects coming into focus in front of the retina, resulting in blurred distance vision. Myopia is the most common ocular disorder worldwide, with increasing prevalence over the past decades, predominantly in East Asia. Previous studies suggested that environmental factors, such as near-work demands, likely play an important role in myopia development in the younger population.

Near work, a main environmental-based factor in the development and progression of permanent myopia (PM), induced via near work-induced transient myopia (NITM). Compared with PM, NITM refers to the prolonged period required for the accommodation of the eyes to return to a normal level after engaging in a sustained near task. It was proposed some years ago that NITM, which produces minor and chronic retinal defocus, may be one of many possible environmentally-based, myopigenic, contributory factors to permanent myopia.

As a nonselective muscarinic antagonist, atropine eye drops with different concentrations have been reported to slow down the myopic progression in myopes. Recently, a two weeks study assessed the efficacy of a low-concentration of atropine (0.01%) on the initial NITM magnitude among Chinese myopic children. The results suggested 0.01% atropine reduced the initial NITM magnitude. However, the long-term efficacy of 0.01% atropine in treating NITM and the relationship between NITM and refractive change after treatment is still unclear.

This study aimed to investigate the efficacy of 0.01% atropine in treating NITM and its possible association with the progression of refractive change in Chinese myopic children.

Enrollment: 150 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 6 to 12 years
• Subjects and their guardians agreed to participate in this study
• Best-corrected visual acuity (BCVA) 0.1 (log minimum angle of resolution, LogMAR) or better.
• Initial NITM (spherical equivalent) ≤ -0.25 D
• Cycloplegic refractions ≥ -1.0 D and astigmatism ≤ 2.5 D in both eyes.
• Anisometropia in both eyes ≤ 1.5 D

Exclusion criteria

• Children with existing systemic diseases including asthma, collagen disease, immune system disorders, prostate hypertrophy, spastic paralysis, Down's syndrome, severe cardiac, pulmonary, hepatic, and renal dysfunction.
• Patients with glaucoma or high intraocular pressure, ocular inflammatory diseases, strabismus, amblyopia, corneal diseases, diseases of lens, retinal and optic neuropathy
• Regular use of medications that may affect the efficacy of 0.01% atropine, including hairy fruit rutabaga eye drops, tropicamide eye drops, anticholinergic drugs such as pirenzepine and tropicamide, and cholinergic drugs such as carbachol and hairy fruit rutabaga.
• Previous experiences with myopia control therapy.
• A history of allergies to atropine.
• Patients were deemed inappropriate for trial participation by the lead investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

study group

Experimental group

Description:

Participants in the study group will use 0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,

Treatment:

Drug: 0.01% atropine

placebo eye drops

Other group

Description:

participants in the control group will utilize placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks.

Treatment:

Other: 0.9% sodium chloride