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Study on the efficacy and safety of defocus frame glasses and 0.01 % atropine in children with intermittent exotropia and myopia

Study on the efficacy and safety of defocus frame glasses and 0.01 % atropine in children with intermittent exotropia and myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108644
Enrollment
Unknown
Registered
2025-09-03
Start date
2025-09-06
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

intermittent exotropia with myopia

Interventions

group of defocus frame glasses:Wearing defocus frame glasses
group of 0.01 % atropine:receive 0.01% atropine

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1 . Confirmed diagnosis of intermittent exotropia; 2 . The clinic control scores of near and far viewing were <= 3 points; 3 . 6 ~ 12 years old ( when agreeing to join ) ; 4 . After cycloplegia, the equivalent spherical diopter of both eyes was between-4.0 and-0.5 diopter ( D ), the astigmatism of both eyes was <= 1.5D, and the anisometropia was <= 1.5D; 5 . Best corrected visual acuity ( BCVA ) <= 0.10 logMAR.

Exclusion criteria

Exclusion criteria: 1 . Patients with ocular organic diseases; 2 . History of eye surgery; 3 . There is a history of systemic diseases such as tumor, heart disease, hypertension, epilepsy, mental illness and so on; 4 . Known atropine allergy; 5 . Peripheral anterior chamber depth < 1 / 3 corneal thickness; 6 . Participate in other intervention trials in the past 6 months; 7 . Have received any myopia control treatment in the past 6 months, including orthokeratology, atropine eye drops, defocus lens, etc; 8 . In the past 6 months, patients had received non-surgical treatment of strabismus, including negative lens overcorrection, prism, visual training, etc. ( except refractive correction ).; 9 . For safety reasons or the interests of patients, the researchers believe that patients should not participate in other cases of this trial.

Design outcomes

Primary

MeasureTime frame
One-year axial length changes;

Secondary

MeasureTime frame
Two-year axial length changes;Diopter;Angle of deviation;Control score;Stereoacuity;Fusional vergence amplitude;BCVA;Intraocular pressure;Accommodative amplitude;

Countries

China

Contacts

Public ContactLiu Hu

The First Affiliated Hospital of Nanjing Medical University

liuhu@njmu.edu.cn+86 139 5209 1066

Outcome results

None listed

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