Topical 0.01% Atropine for the Control of Fast Progressing Myopia (Myopie-STOP)

August 28, 2024 updated by: University Hospital, Strasbourg, France

Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular.

The management of myopia and its complications is therefore a major public health issue.

All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia.

The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67000
        • CHU de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Children from 4 to 12 years

  • Myopia from -1 to -6
  • Fast progressing myopia (>0.75 diopter / year)
  • Informed consent obtained

Exclusion Criteria:

Astigmatism > 1.5 diopters

  • Anisometropia > 2 diopters
  • Concomitant pathology of anterior or posterior segments
  • Other ocular diseases (Ocular inflammation, strabismus …)
  • Atropine hypersensitivity or allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
1 drop per day in both eyes for 1 year
Experimental: Atropine 0.01%
Drug: Atropine 0.01%
1 drop per day in both eyes for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myopia in spherical diopters
Time Frame: 12 months
Automatic measurement of myopia in spherical diopters under cycloplegia
12 months
Myopia in spherical diopters
Time Frame: 9 months
Automatic measurement of myopia in spherical diopters under cycloplegia
9 months
Myopia in spherical diopters
Time Frame: 6 months
Automatic measurement of myopia in spherical diopters under cycloplegia
6 months
Myopia in spherical diopters
Time Frame: 3 months
Automatic measurement of myopia in spherical diopters under cycloplegia
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 3 months
3 months
Adverse events
Time Frame: 12 months
12 months
Adverse events
Time Frame: 6 months
6 months
Axial length
Time Frame: 12 months
12 months
Axial length
Time Frame: 6 months
6 months
Axial length
Time Frame: 3 months
3 months
Axial length
Time Frame: 9 months
9 months
Adverse events
Time Frame: 9 months
9 months
Quality of life questionnaire
Time Frame: 12 months
12 months
Quality of life questionnaire
Time Frame: 9 months
9 months
Quality of life questionnaire
Time Frame: 6 months
6 months
Quality of life questionnaire
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Arnaud SAUER, MD, University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2020

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

June 3, 2024

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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