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A clinical study of low-dose atropine eye drops in children with intermittent exotropia combined with myopia

A clinical study of low-dose atropine eye drops in children with intermittent exotropia combined with myopia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075312
Enrollment
Unknown
Registered
2023-09-01
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

intermittent exotropia combined with myopia

Interventions

0.01% atropine group:0.01% low concentration atropine eye drops once every night
0.02% atropine group:0.02% low concentration atropine eye drops once every night
0.04% atropine group:0.04% low concentration atropine eye drops once every night

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1) between 6-12 years of age; 2) basic type of intermittent exotropia (IXT); 3) having myopic refraction (spherical equivalent, SE) by cycloplegic autorefraction = -0.5 diopters (D) and >-6 D in both eyes; 4) having a best-corrected distance visual acuity (BCVA) of = 0.2 logarithms of the minimum angle of resolution (logMAR) (i.e., Snellen 20/32 or better) in each eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart.

Exclusion criteria

Exclusion criteria: (1) diagnosed of ocular diseases or having clinically significant abnormal findings in the ocular examinations; (2) having intraocular pressure (IOP) > 21 mmHg in either eye; (3) having astigmatism by cycloplegic autorefraction = 2 D in either eye; (4) with serious health problems or cognitive disability affecting follow-up or failure to cooperate with examinations; (5) participating in other interventional trials; (6) have received any myopia control in the past 6 months, including orthokeratology, atropine eye drops, defocusing lenses and other myopia control methods; (7) allergic to atropine; (8) with peripheral anterior chamber depth < 1/3 corneal thickness;

Design outcomes

Primary

MeasureTime frame
refraction diopter;axial length;stereoacuity;office-based control scales;deterioration rate;exodeviation magnitude;

Secondary

MeasureTime frame
pupil diameter;accommodative amplitude ;accommodative convergence/accommodation;Choroid related indicators;peripheral refraction;higher-order aberrations;near point of convergence;dry eye related indicators;corneal endothelium;

Countries

China

Contacts

Public ContactLiu Hu

The First Affiliated Hospital with Nanjing Medical University

liuhu@njmu.edu.cn+86 25 6813 6470

Outcome results

None listed

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