To compare the efficiency of drops versus the specially designed spectacles (DIMS) to slow down the increase in myopia (shortsightedness) in children.

Not Applicable

• Conditions: Health Condition 1: H521- Myopia

• Registration Number: CTRI/2023/03/050441
• Lead Sponsor: HOYA Holdings

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Children with myopia of SE between -0.50 D and -10.00 D (combination of -6.00DS and -4.00 DC) of age group 6-12 years

2) Documented history of myopia progression by more than - 0.50D and/or increase in axial length by more than 0.20mm between 6 months to one year while using 0.01% atropine once daily

3) Corrected VA is = 0.1 Log MAR or 0.8 in Snellen.

Exclusion Criteria

1) Prior use of 0.01% low dose atropine twice a day

2) History of any previous myopia control intervention other than 0.01% low dose atropine

3) History of any ocular or systemic disease

4) History of any previous ocular surgery or trauma

5) Anisometropia > - 2.00 D; Astigmatism > - 1.50 D and Amblyopia

6) Any hypersensitivity/allergic reaction with use of 0.01% atropine

7) Myopia of higher than -8.00D (limited by availability of DIMS spectacle lens in power higher than that)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of myopia progression in terms spherical equivalent over 1 year of period.Timepoint: At baseline, 6 months and 1 year (total 18 months)

Secondary Outcome Measures

Name	Time	Method
To evaluate the change in axial length and choroidal thickness over 18 months.Timepoint: At baseline, 6 months and 1 year (total 18 months)