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OpenTrials
Completed

NCT Number: NCT03374306

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry, Hong Kong Polytechnic University

Hong Kong, 00000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine (0.01%)

Drug

tropical application

Artificial tear

Drug

tropical application

Primary outcomes

  1. Annualized Changes in Refractive Error (SER)

    Time frame: 18 months

    Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months

Secondary outcomes

  1. Annualized Change in Axial Length

    Time frame: 18 months

    Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • The University of Hong Kong

Registry information

Official study title

Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 15, 2017
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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