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

Phase 4

Not yet recruiting

Conditions: Astigmatism,

Registration Number: CTRI/2019/05/018970

Lead Sponsor: DrAbraham Kurian

Brief Summary: **STUDY OBJECTIVE :** To evaluate the efficacy and safety of low strength atropine eyedrops 0.01% in preventing progression of compound myopic astigmatism in children and young adults

**CLINICAL HYPOTHESIS :** Low dose atropine (0.01%) eyedrops is effective in preventing or slowing down the progression of myopic component of Compound myopic astigmatism in children as well as young adults, with minimal or insignificant side effects.

Single centre, Randomised Controlled Trial; Parallel group, Intervetional study design

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 baseline. The secondary outcome will be the change in axial length with respect to the baseline measurement.

The ATOM studies established the effect of Atropine in preventing the progression of low to moderate myopia and it was concluded that at low strength of 0.01% the drug showed optimum efficacy with minimal side effects and minimal rebound.

However the study failed to study high myopes (>6 D) and children above 12 years while myopic progression can continue in young adults. Also the study duration was limited which fails to bring out the persistence of the long term results.

The study also excluded eyes with coexisting astigmatism > 1.5D

In our experience it is seen that Compound Myopic astigmatism is the most common refractive error in children in our population, rather than Simple Myopia and the myopic component of Compound Myopic astigmatism has been shown to progress as in simple myopia.

So we designed this study to study the efficacy of low strength Atropine (0.01%) in the Indian population, to assess its efficacy in Compound myopic astigmatism and to assess the persistence of the efficacy as well as the safety profile for a longer period. Also we intended to include a higher age group ie upto 15 years (Inclusion age: 5-15 years) which was not included in the ATOM studies.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

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 baseline	1 year

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be the change in axial length with respect to the baseline measurement.	1 year

Trial Locations

Locations (1): Chaithanya Eye Hospital and Research Institute
🇮🇳
Thiruvananthapuram, KERALA, India
Chaithanya Eye Hospital and Research Institute
🇮🇳Thiruvananthapuram, KERALA, India
Dr Iodine Reghunadhan
Principal investigator
9847104830
iodine_b@yahoo.com