Atropine 0.01% Eye Drops in Myopia Study

NCT03508817 | Unknown Early Phase 1

• 1 other identifier: MREC 1473
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atropine, myopia, children

Outcome Measures

Primary Outcomes (1)

• The primary outcome is progression of myopia

  defined as the change in spherical equivalent refractive error (SER) relative to baseline

  2 years

Secondary Outcomes (1)

• change in axial length

  2 years

Other Outcomes (1)

• monitor of adverse events

  3 years

Study Arms (2)

Atropine Sulfate 0.01% Eye Drops Group

EXPERIMENTAL

Intervention group will receive atropine sulphate eye drops 0.01% once nightly for 2 years.

Drug: Atropine Sulfate 0.01% Eye Drops

Control group

NO INTERVENTION

Control group will not receive any medication.

Interventions

Atropine Sulfate 0.01% Eye Drops DRUG

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

Also known as: Atropine

Atropine Sulfate 0.01% Eye Drops Group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 6 to 15 years
• Myopia ≥ 2.00 D (cycloplegic refraction; spherical equivalent)
• No prior or current treatment for preventing myopia progression (bifocals / progressive addition lenses / orthokeratology)

You may not qualify if:

• Best corrected visual acuity \< 0.5 (6/12)
• Refractive Myopia
• Astigmatism ≥ 1.5 D
• Amblyopia
• Ocular hypertension / Glaucoma
• Prior intraocular surgery
• Allergy to atropine eye drops
• Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome
• History of cardiac or significant respiratory diseases
• Lack of consent for participating in the study

Sponsors & Collaborators

• Sultan Qaboos University: lead
• Christian Medical College, Vellore, India: collaborator

Study Sites (1)

Sultan Qaboos University

Muscat, 123, Oman

Location

Related Publications (2)

• Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012 Feb;119(2):347-54. doi: 10.1016/j.ophtha.2011.07.031. Epub 2011 Oct 2.

  PMID: 21963266 BACKGROUND

• Gong Q, Janowski M, Luo M, Wei H, Chen B, Yang G, Liu L. Efficacy and Adverse Effects of Atropine in Childhood Myopia: A Meta-analysis. JAMA Ophthalmol. 2017 Jun 1;135(6):624-630. doi: 10.1001/jamaophthalmol.2017.1091.

  PMID: 28494063 BACKGROUND

MeSH Terms

Conditions

Myopia, Degenerative; Myopia

Interventions

Atropine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Anuradha Ganesh, MD

  Sultan Qaboos University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: Intervention group: Optimal myopia correction with single vision glasses and topical atropine 0.01%, one drop at night time. Control group: Optimal myopia correction with single vision glasses

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: April 26, 2018
• Study Start: December 20, 2018
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

OM (1)