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Low dose Atropine for Myopia control

COMPARATIVE STUDY OF MYOPIA PROGRESSION IN SUBJECTS ON LOW DOSAGE OF ATROPINE WITH MATCHED CONTROLS OF DIFFERENT AGE GROUPS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021193
Enrollment
80
Registered
2019-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H521- Myopia

Interventions

Intervention1: Low dose atropine eyedrops (0.01%): Topical instillation of low dose atropine eyedrops in both eyes at night time, daily, alongwith glass use (one eyedop in each eye, once daily dosage

Sponsors

Centre for Sight
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 6 to 18 years 2. Myopia >= 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. 4. 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

Exclusion criteria: 1. Best corrected visual acuity 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.

Design outcomes

Primary

MeasureTime frame
1.Change in spherical equivalent refractive error (SER) relative to baseline (Indicator of progression of myopia) 2. Change in axial length during follow-up relative to baseline (Increased axial length correlates with myopic progression). Timepoint: 2years—

Secondary

MeasureTime frame
Any adverse events (blurred near vision, glare, allergic reaction, if any)Timepoint: 2 years—

Countries

India

Contacts

Public ContactDr Sumit Monga

Centre for Sight

drsumitmonga@gmail.com01142504250

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026