Clinical trial NCT06034366: the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression
Official title: a Parallel Assignment Prospective, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nearwork-induced transient myopia (NITM) in diopter
timeFrame: At baseline, week 4, week 12, week 24, week 36, and week 48
Secondary outcomes:
measure: Spherical equivalent (SE) in diopter
timeFrame: At baseline, week 4, week 12, week 24, week 36, and week 48
measure: Axial length (AL) in millimetre
timeFrame: At baseline, week 4, week 12, week 24, week 36, and week 48
measure: 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)
timeFrame: At baseline, week 4, week 12, week 24, week 36, and week 48
Other outcomes:
measure: Safety evaluation of best corrected visual acuity (BCVA)
timeFrame: At baseline, week 4, week 12, week 24, week 36, and week 48
measure: Safety evaluation of pupil size
timeFrame: At baseline, week 4, week 12, week 24, week 36, and week 48
measure: Safety evaluation of intraocular pressure
timeFrame: At baseline, week 4, week 12, week 24, week 36, and week 48
Locations:
city: Shenyang
country: China
facility: He Eye Hospital
state: Liaoning
city: Shenyang
country: China
facility: He Eye Specialist Hospital
Study officials:
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