Effect of 0.01% Atropine in children with Myopia
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- RASHMI K
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Degree of myopia progression defined as change in spherical equivalent over 2 years study period as measured by cycloplegic refraction.
Overview
Brief Summary
Myopia also known as ’SHORT SIGHT’ is a refractive error in which incident parallel rays come to focus anterior to the retina when accomodation is at rest.Control of myopia progression has become an important goal because of concerns regarding significantly increased risk of retinal detachment,glaucoma,retinal degeneration and cataract associated with high myopia.Atropine sulfate eye drops has consistently been demonstrated to inhibit axial myopia progression in both humans and animal models. Recently 0.01% Atropine eye drops has been shown to be effective in arresting myopia progression without side effects of cycloplegia,near vision impairment,pupil dilatation and increased light sensitivity.So we plan to evaluate the efficacy and safety of topical 0.01% Atropine eye drops in slowing progression of myopia and ocular elongation in our population. Children aged 6 - 18 years coming to ophthalmology OPD of Kasturba Medical College, Manipal who are diagnosed with compound Myopia of -2.00D or more and astigmatism of -1.50D or less in one or both eyes will be included in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Open Label
Eligibility Criteria
- Ages
- 6.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children both male and female aged 6-18 years with compound myopia of atleast -2.00D or more and astigmatism -1.50 D or less attending Ophthalmology OPD in Kasturba Medical College, Manipal.
Exclusion Criteria
- •1.Myopia due to glaucoma 2.Any ocular trauma 3.Any ocular surgery.
Outcomes
Primary Outcomes
Degree of myopia progression defined as change in spherical equivalent over 2 years study period as measured by cycloplegic refraction.
Time Frame: Degree of myopia progression defined as change in spherical equivalent over 2 years study period as measured by cycloplegic refraction. | Change in axial length as measured by IOL master.
Change in axial length as measured by IOL master.
Time Frame: Degree of myopia progression defined as change in spherical equivalent over 2 years study period as measured by cycloplegic refraction. | Change in axial length as measured by IOL master.
Secondary Outcomes
- Side effects of long term use of 0.01% Atropine eye drops(Assessed every 6 months for the period of 2 years)