Atropine eye drops to decrease myopia progression in children

Completed

• Conditions: Myopia

• Registration Number: CTRI/2016/11/007450
• Lead Sponsor: Dr Rajendra Prasad Centre for Ophthalmic Science

Brief Summary

Myopia has emerged as a worldwide public health issue ans is 1 of the 5 ocular conditions identified as immediate priorities by the World Health Organizations’s Global Initiative for the Elimination of Avoidable Blindness. In addition to the optical impact of myopia on vision and the associated costs of correction, myopia is a major risk factor for ocular disease. Myopia increases the risk of eye diseases including glaucoma, cataract and retinal detachment.The risk of myopia are significant even in low to moderate myopes and comparable to the risks of smoking and hypertension to cardiovascular diseases.Standard of care currently treats only the optical and medical consequences of myopia rather than limiting its progression.There have been various methods in past described for control of progression of myopia.Among these methods Atropine 0.01 % have been shown to control myopia progression with minimal side effects. There have been no studies yet assessing effect of 0.01 % atropine eyedrops in Indian population for controlling myopia progression.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-12
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Age 6-12 years Refractive error of spherical equivalent between -2D to -6D in each eye as measured by cycloplegic autorefraction Distance vision correctable to logMAR 0.2 or better in both eyes Normal ocular health other than myopia Informed consent Willing to follow-up.

Exclusion Criteria

• Astigmatism more than -1.5 D as measured by cycloplegic autorefraction Amblyopia Strabismus Allergy to atropine or homatropine Previous or concurrent use of contact lenses, bifocals, progressive addition lenses or other forms of treatment (including atropine) for myopia History of cardiac , neurologic or significant respiratory diseases.
• Unwilling to give consent/ follow-up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
myopia progression	2 weeks | 2 months | 4 months | 8 months | 1 year

Secondary Outcome Measures

Name	Time	Method
side effects	2 weeks

Trial Locations

Locations (1)

Dr RP Centre; 🇮🇳 Delhi, DELHI, India

Dr RP Centre

🇮🇳Delhi, DELHI, India

Rohit Saxena

Principal investigator

1126593182

rohitsaxena80@yahoo.com