Low dose Atropine for Myopia control

Not yet recruiting

Conditions: Myopia,

Registration Number: CTRI/2019/09/021193

Lead Sponsor: Centre for Sight

Brief Summary: Control of myopia progression has become an important goal, as myopia is a leading cause of visual disability throughout the world. In India uncorrected refractive errors are one of the most common causes of visual impairment. Currently, on average, 30% of the world is myopic and by 2050, based on current trends, almost 50% will be myopic, thatâ€™s 5 billion people.High Myopia may be associated with significantly increased risks of retinal degeneration, retinal detachment, glaucoma and cataract associated with high myopia. 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 (1%) 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 dilation and increased light sensitivity. However, almost all studies on atropine have been carried out on children of Chinese origin (SE Asia). 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 atropine eye drops(0.01%) in slowing the progression of myopia and ocular axial elongation in Indian children. A total of 80 children of ages 6-18 years will be classified into two groups based on age, which will further be randomized into two sub groups. Intervention subgroup for each age group will receive atropine 0.01% once daily in each eye. Control group will not receive any medications. Follow up visits will be scheduled every six months The progression of myopia (change in refractive error and axial length) will be compared in the two groups by objective methods. It will alsobe compared on different grades of myopia and different age groups to state the best time to start myopia control.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Age: 6 to 18 years 2.
Myopia â‰¥ 2.00 D (cycloplegic refraction; spherical equivalent) with or without any astigmatism 3.
The minimum increase in refractive error should be 0.75DS in less than 6 months.
Provide written informed consent; 5.
No prior or current treatment for preventing myopia progression (bifocals / progressive addition lenses / orthokeratology) 6.
Willingness and ability to follow all instructions and comply with schedule for follow-up visits.

Exclusion Criteria

Best corrected visual acuity < 6/18 2.
Simple myopic/hyperopic astigmatism with 0 spherical refractive error (Pure astigmatism) 3.
No prior or current treatment for preventing myopia progression (bifocals / progressive addition lenses / orthokeratology) 4.
Ocular diseases like Retinal dystrophy, Retinopathy of prematurity, Corneal opacities, keratoconus, Ocular hypertension / Glaucoma 5.
Prior intraocular surgery 6.
Allergy to atropine eye drops 7.
Lack of consent for participating in the study 8.
Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome, Down syndrome, cardiac or significant respiratory diseases 9.
Those lost to follow-ups, lack of 80% compliance to Atropine 0.01% eyedrops 10.
In addition, the Investigator may exclude or discontinue any subject for any sound medical reason.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in spherical equivalent refractive error (SER) relative to baseline (Indicator of progression of myopia)	2years
2. Change in axial length during follow-up relative to baseline (Increased axial length correlates with myopic progression).	2years

Secondary Outcome Measures

Name	Time	Method
Any adverse events (blurred near vision, glare, allergic reaction, if any)	2 years

Trial Locations

Locations (1): Centre for Sight Eye Institute
🇮🇳
West, DELHI, India
Centre for Sight Eye Institute
🇮🇳West, DELHI, India
Dr Nayak
Principal investigator
01142504250
ms@centreforsight.net