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A study on how low dose atropine eye drops affect pupil size and focusing ability in children with nearsightedness

Effect of low dose atropine 0.01 percent for progressive myopia on pupil and accommodation - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/111790
Enrollment
30
Registered
2026-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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 0.01% eye drops: Dose is 0.01% atropine eye drops Frequency is one drop daily at night Duration is for 2 years Route of administration is topical. Control Interventi

Sponsors

Sankara Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children aged between 6 to 16 years diagnosed with progressive myopia who will be treated with topical low-dose atropine 0.01 percent for myopia progression control. 2.Parents and their children willing for the study 3.Cycloplegic spherical equivalent of more than equal to 1 diopter of myopia in each eye 4.Documented myopia progression over previous 12 months in either eye 5.Best-corrected visual acuity (logMAR, logarithm of minimum angle of resolution) of 0.2 (equivalent Snellen fraction 6 by 9) or better in each eye

Exclusion criteria

Exclusion criteria: 1.Past history of any ocular surgery 2.Unilateral myopia 3.Suppression of any eye 4.Patients with pre-existing ocular surface disorders like blepharitis, dry eye, chemical injuries, chronic allergic conjunctivitis and meibomian gland dysfunction. 5.Known case or previously diagnosed case of uveitis, scleritis or keratitis. 6.History of known hypersensitivity to atropine or use of atropine in the past. 7.Developmental delay that renders them unable to carry out eye tests 8.Ocular comorbidities including amblyopia, glaucoma, aphakia, strabismus, pseudophakia 9.Patients with ocular disorders known to affect pupil size and reactivity will be excluded from the study. 10.Systemic comorbidities including cardiac or respiratory disease, and connective tissue disease e.g. Marfan Syndrome etc. 11.Previously received atropine therapy for amblyopia or myopia progression. 12.Use of orthokeratology lenses within the past 3 months. 13.Patients not complaint for low dose atropine eye drops,a diary has to be maintained by parents regarding daily application of the LDA eye drops, compliance of at least 5 days a week has to be instilled 14.Patients who will not be brought for follow-up. 15.Astigmatism more than 2.00 DC

Design outcomes

Primary

MeasureTime frame
1. To analyze pupil size during dynamic, photopic, mesopic and scotopic conditions by using MYAH Machine a non invasive method. 2. To analyze accommodation parameters which will include amplitude of accommodation, accommodative facility, lead and lag of accommodation manually by a single trained optometrist.Timepoint: 1. To analyze pupil size during dynamic, photopic, mesopic ,scotopic conditions by using MYAH Machine at baseline, 1 week, 4 weeks, and 12 weeks 2. To analyze accommodation parameters which will include amplitude of accommodation, accommodative facility, lead and lag of accommodation manually at baseline, 1 week, 4 weeks, and 12 weeks

Secondary

MeasureTime frame
To assess subjective symptoms which will include discomfort in bright light & blurring of near visionTimepoint: To assess subjective symptoms which will include discomfort in bright light & blurring of near vision at baseline, 1 week,4 weeks & 12 weeks.

Countries

India

Contacts

Public ContactDr Gagan Goswami

Sankara Eye Hospital , Shimoga

kavithachalam2@gmail.com9663329877

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026