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

Sponsor
He Eye Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06034366
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.01% atropine
  • Other: 0.9% sodium chloride
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
May 31, 2025
Anticipated Study Completion Date :
May 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: study group

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

Drug: 0.01% atropine
0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,
Other: placebo eye drops

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.

Other: 0.9% sodium chloride
placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks

Outcome Measures

Primary Outcome Measures

  1. Nearwork-induced transient myopia (NITM) in diopter [At baseline, week 4, week 12, week 24, week 36, and week 48]

    WAM-5500; Grand Seiko, Japan, will be used to assess the NITM in diopter unit.

Secondary Outcome Measures

  1. Spherical equivalent (SE) in diopter [At baseline, week 4, week 12, week 24, week 36, and week 48]

    WAM-5500; Grand Seiko, Japan, will be used to assess the SE of each eye in diopter unit.

  2. Axial length (AL) in millimetre [At baseline, week 4, week 12, week 24, week 36, and week 48]

    Zeiss IOL Master 700 will be used to assess the AL of each eye in diopter unit.

  3. 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) [At baseline, week 4, week 12, week 24, week 36, and week 48]

    The NEI-VFQ-25 contains 25 questions: general health, general vision, ocular pain, distance, near tasks, dependency on others, role limitation, mental health, social function, driving, peripheral vision, and color vision difficulty. The answer is converted into a 100-point scale for each question, with 100 being the best and 0 the worst. One or more questions are specific to each subscale; therefore, the subscale score is the average of one or more specific questions. The Chinese version of the NEI-VFQ-25 questionnaire was used

Other Outcome Measures

  1. Safety evaluation of best corrected visual acuity (BCVA) [At baseline, week 4, week 12, week 24, week 36, and week 48]

    Best-corrected visual acuity (BCVA) 0.1 (log minimum angle of resolution, LogMAR) chart will be used to assess BCVA of each eye.

  2. Safety evaluation of pupil size [At baseline, week 4, week 12, week 24, week 36, and week 48]

    Pupil size in millimetres will be measured using OPD-Scan III, Nidek, Japan.

  3. Safety evaluation of intraocular pressure [At baseline, week 4, week 12, week 24, week 36, and week 48]

    Intraocular pressure (IOP) in mmHg using a tonometry.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • Myopic refractions ≥ -1.0 D and astigmatism ≤ 2.5 D in both eyes.

Exclusion Criteria:

  • Children with systemic diseases or ocular diseases.

  • previous experiences with myopia control therapy

  • a history of allergies to atropine.

  • Patients were deemed inappropriate for trial participation by the lead investigator.

Contacts and Locations

Locations

Site City State Country Postal Code
1 He Eye Hospital Shenyang Liaoning China 110034

Sponsors and Collaborators

  • He Eye Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
He Eye Hospital
ClinicalTrials.gov Identifier:
NCT06034366
Other Study ID Numbers:
  • atropine2023
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myopia
Atropine

Study Results

No Results Posted as of Sep 13, 2023