Atropine 0.01% Eye Drops in Myopia Study

• Status: Enrolling by invitation
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sultan Qaboos University
• Collaborator: Christian Medical College, Vellore, India
• Treatments: Atropine; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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