Northern Finland Birth Cohort eye study
| ISRCTN | ISRCTN88555958 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88555958 |
| Secondary identifying numbers | 71016 |
- Submission date
- 20/09/2013
- Registration date
- 04/10/2013
- Last edited
- 12/02/2021
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Glaucoma is a group of eye conditions in which the optic (eye) nerve is damaged due to changes in eye pressure. Although glaucoma is treatable, it is a major cause of blindness worldwide. The objective is to study the effects of screening for eye diseases on the individuals and on society.
Who can participate?
Members of the Northern Finland Birth Cohort, born 1966.
What does the study involve?
The patients are randomly allocated to either the screening group or the no screening group. They are screened for eye diseases mainly glaucoma, with ocular imaging [visual field examinations, sharpness of vision and eye pressure measurements]. The effect of screening will be compared with no screening.
What are the possible benefits and risks of participating?
The main benefit is timely diagnosis of glaucoma, therefore avoiding the possible damage to eyesight due to the progression of glaucoma. All the investigations are non-invasive and generally well-tolerated by patients. Rarely, some people may experience mild and passing discomfort due to the dilatation of pupils.
Where is the study run from?
Oulu University Hospital, Finland.
When is the study starting and how long is it expected to run for?
The study started in April 2012 and is expected to run for 16 years.
Who is funding the study?
Silmäsäätiö, Finland.
Who is the main contact?
Ville Saarela
Contact information
Scientific
Department of Ophthalmology
P.O. Box 21
OYS
Finland
Oulu
90029
Finland
Study information
| Study design | 1. Randomised screening trial 2. Diagnostic cohort study 3. Cost-effectiveness trial and cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Northern Finland Birth Cohort eye study: a randomised screening trial |
| Study objectives | Evaluation of the effectiveness and cost effectiveness of glaucoma screening. |
| Ethics approval(s) | Northern Ostrobothnia Hospital district, Finland |
| Health condition(s) or problem(s) studied | Glaucoma |
| Intervention | Screening for eye diseases, mainly glaucoma, with ocular imaging (scanning laser polarimetry, optical coherence tomography, retinal nerve fibre layer photography, scanning laser ophthalmoscopy, stereoscopic optic nerve head photography) 2. Visual field examinations 3. Visual acuity and intraocular pressure. The patients are randomised with respect to age, gender and area of residence. The effect of screening will be compared with no screening after 16 years. |
| Intervention type | Other |
| Primary outcome measure | The clinical evaluation of glaucomatous damage in the visual fields, optic nerve head and retinal nerve fibre layer will be compared with the group with screening and those without screening, after 16 years |
| Secondary outcome measures | Effectiveness and cost-effectiveness |
| Overall study start date | 01/04/2012 |
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 3350 |
| Total final enrolment | 10321 |
| Key inclusion criteria | Randomized members of Northern Finland Birth Cohort (born in 1966 in the two northernmost provinces in Finland) |
| Key exclusion criteria | Those who are not a part of Northern Finland Birth Cohort |
| Date of first enrolment | 01/04/2012 |
| Date of final enrolment | 31/12/2028 |
Locations
Countries of recruitment
- Finland
Study participating centre
90029
Finland
Sponsor information
Research organisation
Mannerheimintie 136 A 28
Helsinki
00270
Finland
| Website | http://www.silmasaatio.fi/ |
|---|---|
"ROR" |
https://ror.org/033r0hh63 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/10/2013 | 12/02/2021 | Yes | No |
| Results article | glaucoma prevalence results | 01/03/2019 | 12/02/2021 | Yes | No |
Editorial Notes
12/02/2021: The following changes have been made:
1. Publication references added.
2. The final enrolment number has been added from the 2018 reference.
