Atropine eyedrops for preventing increase in refractive error (shortsight and astigmatism)

Phase 4

Conditions: Health Condition 1: H522- Astigmatism

Registration Number: CTRI/2019/05/018970

Lead Sponsor: DrAbraham Kurian

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Children or Young adults in the age group 5-15 years.

2.Myopic refractive error of spherical equivalent > 1.00D as measured by cycloplegic refraction

3.Astigmatism of > 1.50D as measured by cycloplegic refraction

4.Documented progression of myopic component of Compound Myopic astigmatism

5.Ability to understand and follow the study instructions you receive and likely to be amenable for 1 year followup.

6.Normal ocular health other than refractive error

7.Normal Intraocular pressure ( <21 mm Hg)

Exclusion Criteria

1.Known Allergy or hypersensitivity to Atropine, Cyclopentolate, Phenyl ephrine or Proparacaine

2.Amblyopia in atleast one eye

3.History of significant cardiac or respiratory illness

4.Current enrolment in another investigational study or participation in such a study within 30 days of entry into this study

5.No previous or current use of contact lenses or bifocals or progressive lenses or other forms of treatment (including Atropine in any strength) for myopia

6.Patient has a condition or situation which in the investigators opinion, may put the patient at a significant risk, may confound the study results, or interfere with the participation in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be progression of the myopic component of Compound Myopic astigmatism estimated as the change in spherical equivalent refractive error relative to the baselineTimepoint: 1 year

Secondary Outcome Measures