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Atropine 0.01% Eye Drops in Myopia Study

NCT03508817 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-08-06

No results posted yet for this study

Summary

Control of myopia progression has become an important goal because of concerns regarding significantly increased risks of retinal degeneration, retinal detachment, glaucoma and cataract associated with high myopia. It is also clear there prevalence of myopia in children and young adults is increasing all over the world. Several methods including use of progressive addition lenses, rigid gas-permeable contact lenses, and life-style modifications (increased outdoor activity) have reported to alter myopia progression with varying efficacy. In general they have yielded clinical results of marginal significance. Atropine sulphate eye drops has consistently been demonstrated to inhibit axial myopia progression in both humans and animal models. Yet it has not found widespread clinical application for myopia control due to ocular side-effects of cycloplegia and pupil dilation. Recently 0.01% atropine has been shown to be effective in arresting myopia progression without side-effects of cycloplegia and near vision impairment and pupil dilatation and increased light sensitivity. Almost all studies on atropine have been carried out on children of Chinese origin. Efficacy (concentration and dosing) and safety need to be established in the population of interest, before routine use can be recommended. We plan to evaluate the efficacy and safety of topical 0.01% atropine eye drops in slowing the progression of myopia and ocular axial elongation in Omani children. A total of 150 children of ages 6-16 years will be randomized to two groups. Intervention group will receive atropine 0.01% once daily in each eye for two years (Phase 1). Control group will not receive any medications. Follow up visits will be scheduled every three months in Phase 1. Subsequently, medication will be stopped and the study patients will be followed up every six months for one year (Phase 2). The progression of myopia (change in refractive error and axial length) will be compared in the two groups by objective methods.

Conditions

  • Myopia, Progressive

Interventions

DRUG

Atropine Sulfate 0.01% Eye Drops

atropine eye drop in study eye once nightly for two years.

Sponsors & Collaborators

  • Christian Medical College, Vellore, India

    collaborator OTHER

  • Sultan Qaboos University

    lead OTHER

Principal Investigators

  • Anuradha Ganesh, MD · Sultan Qaboos University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • Oman

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508817 on ClinicalTrials.gov