Effects of pupil-dilating drug on myopia progression and intraocular pressure elevation
| ISRCTN | ISRCTN33002849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33002849 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/01/2016
- Registration date
- 31/05/2016
- Last edited
- 30/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
6F, Department of Ophthalmology
Chang Gung Memorial Hospital
222, MaiJing Rd
An Leh District
Keelung
204
Taiwan
Study information
| Study design | Single site prospective, interventional longitudinal and non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effects of topical atropine on intraocular pressure and myopia progression |
| Study objectives | 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(s) | Institutional Review Board at Chang Gung Memorial Hospital, Taiwan, 30/01/2009, ref: 97-1988A3 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Atropine |
| Primary outcome measure | 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 study start date | 01/03/2009 |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 60 children |
| Total final enrolment | 56 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/05/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
204
Taiwan
Sponsor information
Hospital/treatment centre
6F, Department of Ophthalmology
Chang Gung Memorial Hospital
222, MaiJing Rd
An Leh District
Keelung
204
Taiwan
"ROR" |
https://ror.org/02verss31 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/07/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/07/2016 | 30/11/2020 | Yes | No |
Editorial Notes
30/11/2020: Publication reference and total final enrolment added.
