Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-01 @ 9:00 PM
Study NCT ID:
NCT06034366
Status:
UNKNOWN
Last Update Posted:
2023-11-29
First Post:
2023-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression
Sponsor:
He Eye Hospital
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: