Condition category
Eye Diseases
Date applied
20/09/2013
Date assigned
04/10/2013
Last edited
04/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ville Saarela

ORCID ID

Contact details

Department of Ophthalmology
P.O. Box 21
OYS
Finland
Oulu
90029
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

71016

Study information

Scientific title

Northern Finland Birth Cohort eye study: a randomised screening trial

Acronym

Study hypothesis

Evaluation of the effectiveness and cost effectiveness of glaucoma screening.

Ethics approval

Northern Ostrobothnia Hospital district, Finland

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

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2012

Overall trial end date

31/12/2028

Reason abandoned

Eligibility

Participant inclusion criteria

Randomized members of Northern Finland Birth Cohort (born in 1966 in the two northernmost provinces in Finland)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3350

Participant exclusion criteria

Those who are not a part of Northern Finland Birth Cohort

Recruitment start date

01/04/2012

Recruitment end date

31/12/2028

Locations

Countries of recruitment

Finland

Trial participating centre

Department of Ophthalmology
Oulu
90029
Finland

Sponsor information

Organisation

Silmäsäätiö (Finland)

Sponsor details

Mannerheimintie 136 A 28
Helsinki
00270
Finland

Sponsor type

Research organisation

Website

http://www.silmasaatio.fi/

Funders

Funder type

Research organisation

Funder name

Silmäsäätiö (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes