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

November 23, 2023 updated by: He Eye Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shenyang, China, 110034
        • Recruiting
        • He Eye Specialist Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110034
        • Recruiting
        • He Eye Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Qin Guanghao, MD
        • Sub-Investigator:
          • Li Liangzhe, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nearwork-induced transient myopia (NITM) in diopter
Time Frame: 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.
At baseline, week 4, week 12, week 24, week 36, and week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spherical equivalent (SE) in diopter
Time Frame: 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.
At baseline, week 4, week 12, week 24, week 36, and week 48
Axial length (AL) in millimetre
Time Frame: 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.
At baseline, week 4, week 12, week 24, week 36, and week 48
25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)
Time Frame: 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
At baseline, week 4, week 12, week 24, week 36, and week 48

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation of best corrected visual acuity (BCVA)
Time Frame: 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.
At baseline, week 4, week 12, week 24, week 36, and week 48
Safety evaluation of pupil size
Time Frame: 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.
At baseline, week 4, week 12, week 24, week 36, and week 48
Safety evaluation of intraocular pressure
Time Frame: At baseline, week 4, week 12, week 24, week 36, and week 48
Intraocular pressure (IOP) in mmHg using a tonometry.
At baseline, week 4, week 12, week 24, week 36, and week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

September 10, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • atropine2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high-impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myopia

Clinical Trials on 0.01% atropine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe