Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate

The Hong Kong Polytechnic University

Status: Completed

Conditions: Myopia

Treatments: Drug: Artificial tear; Drug: Atropine (0.01%)

Study type: Interventional

Funder types: Other

Identifiers

NCT03374306

HongKongPU_Optometry1

Details and patient eligibility

About

Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.

Enrollment: 71 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age between 7 and 10 years
• Good general health and no family history of ocular diseases
• No current or history of epilepsy or asthma
• Myopia : -0.50 to -1.00 D (inclusive, both eyes)
• Astigmatism : ≤ 0.50 D
• No hyperopia, amblyopia or strabismus
• No reported ocular eye diseases or disorders
• No drug allergy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 2 patient groups, including a placebo group

Atropine 0.01%

Experimental group

Description:

Group receiving atropine treatment for 18 months

Treatment:

Drug: Atropine (0.01%)

Artifical tear

Placebo Comparator group

Description:

Group receiving placebo for 18 months

Treatment:

Drug: Artificial tear