Condition category
Eye Diseases
Date applied
19/01/2016
Date assigned
31/05/2016
Last edited
24/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Short-sightedness, or myopia, is a common eye condition resulting in distant objects appearing blurred to the sufferer. The condition usually starts from around puberty, but can develop in younger children. The condition gradually gets worse over time. It is caused by the eye stretching and becoming slightly longer than it should. This means that light does not focus on the retina (light-sensitive tissue) of the eye but just in front of it, causing far away objects to look blurred. Myopia is associated with an increase in pressure within the eye (intraocular pressure) over a long period of time. Some studies have shown that the drug atropine slows down the progression of myopia. This study looks at the effects of topical atropine (atropine given as eye drops) on the intraocular pressure of the eye and myopia progression in children and aims to find out the smallest amount of drug that needed (lowest concentration) to get results.

Who can participate?
Short-sighted children aged between 6 and 12 and living in Northern Taiwan.

What does the study involve?
Children are assigned to one of three groups. If the parents state a preference for the child not to be treated with medication, they are assigned to the control group and given glasses to correct their vision if required. If the parents state a preference for their child to be treated with medication, they are randomly allocated to one of two groups. Children in group 2 are given eye drops containing 0.125% atropine in addition to corrective glasses if required. Children in group 3 are given eye drops containing 0.25% atropine in addition to corrective glasses if required. Myopia progression and intraocular pressure is measured at the start of the study and then every 3 months for the next 12 months for all participants.

What are the possible benefits and risks of participating?
In general, there is almost no risk for taking part in this study because atropine use in Taiwan is routine and general practice for myopic children. The only risk, if any, is that those who did not use atropine (control group) will run a rapid myopic progression speed and have a greater chance of high myopia and associated complications during their late adult life.

Where is the study run from?
Chang Gung Memorial Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
March 2009 to March 2011

Who is funding the study?
Chang Gung Medical Research Foundation

Who is the main contact?
Dr Chi-Chin Sun

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chi-Chin Sun

ORCID ID

Contact details

6F
Department of Ophthalmology
Chang Gung Memorial Hospital
222
MaiJing Rd
An Leh District
Keelung
204
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of topical atropine on intraocular pressure and myopia progression

Acronym

Study hypothesis

Topical atropine has been used for a long time to control myopia progression. However, the minimal effective concentration has not been established. Moreover, its effect on intraocular pressure is still in debate. Therefore, we conducted this prospective study.

Ethics approval

Institutional Review Board at Chang Gung Memorial Hospital, Taiwan, 30/01/2009, ref: 97-1988A3

Study design

Single site prospective, interventional longitudinal and non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Myopia in children

Intervention

This is an interventional study that enrolled children with myopia. If the parents state a preference for their child to not receive any medications, they are assigned to the control group with spectacles correction if needed.
If their parents state a preference for their child to be treated with medications, the child is randomly assigned to one of two groups:
1. Child is treated with 0.125% atropine in addition to spectacle correction
2. Child is treated with 0.25% atropine in addition to spectacle correction
All children are followed up for the next 12 months.

Intervention type

Drug

Phase

Not Specified

Drug names

Atropine

Primary outcome measures

Myopia and its progression: with autorefractometer and manifest refraction by experienced technician. Assessed at baseline and then every 3 months for next 12 months.

Secondary outcome measures

IOP measurement: with pneumatic tonometer by experienced technician. Assessed at baseline and then every 3 months for next 12 months.

Overall trial start date

01/03/2009

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children in Northern Taiwan aged between 6 to 12 years.
2. Patients with a refractive error less than -3.0 diopters (D)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60 children

Participant exclusion criteria

1. Congenital eye disorder
2. Any disease influence the cornea, lens or retina
3. Best correct visual acuity<20/25 using the Snellen chart
4. Primary intraocular pressure above 21mmHg
5. Atropine application within 6 months before enrollment
6. Patients who could understand the details of this study or could not adhere to the follow up schedule

Recruitment start date

01/05/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Taiwan

Trial participating centre

Chang Gung Memorial Hospital
Keelung
204
Taiwan

Sponsor information

Organisation

Chang Gung Memorial Hospital

Sponsor details

6F
Department of Ophthalmology
Chang Gung Memorial Hospital
222
MaiJing Rd
An Leh District
Keelung
204
Taiwan

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Chang Gung Medical Research Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This manuscript has been submitted to BMC Ophthalmology and currently under consideration for publication. If possible, we expected it will be published within 3 months. The dissemination targets are those who are interested in myopia control and concern about side effects of mydriatics, including professional Ophthalmologists, public health researchers and the general public.

Intention to publish date

31/07/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes