Screening the elderly for impaired vision: a nested trial within the MRC elderly trial

ISRCTN	ISRCTN53474285
DOI	https://doi.org/10.1186/ISRCTN53474285
Secondary identifying numbers	G9900232

Submission date: 23/10/2000
Registration date: 23/10/2000
Last edited: 24/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Liam Smeeth
Scientific

Epidemiology Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7636 8636
Email	liam.smeeth@lshtm.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	To determine the effectiveness of mass screening for visual impairment in unselected elderly people (aged 75 and over) in a community setting as part of a multidimensional screening programme. To assess barriers to treatment of visual impairment among elderly people.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Primary care
Intervention	In the MRC Elderly Screening Study, practices were randomly allocated as follows: 1. Brief assessment by questionnaire followed by a detailed assessment, including visual acuity, only if indicated (the control group for this study) - the targeted screening group 2. Brief assessment by questionnaire followed by a detailed assessment including visual acuity for all patients (the intervention group for this study) - the universal screening group. In the brief assessment, as one of the 35 questions about their health, participants were asked the following question on vision: 'Do you have difficulty seeing newsprint, even if you are wearing glasses?' In arm A, criteria for triggering to the detailed assessment were three or more problems identified from the brief assessment or any one of four 'serious' symptoms (unexpected weight loss, frequent falls in previous month, vomiting blood, coughing blood). In arm B all participants had a detailed assessment. In the detailed assessment, the participants' distance visual acuity was measured using a logarithm of the minimum angle of resolution (logMAR) chart. Anyone with a pinhole corrected acuity of 0.5 or more (equivalent to Snellen acuity less than 6/18) was referred to an ophthalmologist. If the visual impairment was corrected by use of a pinhole, the participant was referred to an optometrist for refractive error correction. The patient assessments described above began in 1995 and were completed at the end of 1998. All participants are being followed up for mortality and hospital admissions but are not being re-examined as part of the MRC Elderly Screening Trial. We are proposing to conduct a nested trial within the MRC trial, specifically to examine the effectiveness of the visual acuity screening component of the study.
Intervention type	Other
Primary outcome measure	These were changed prior to outcome data collection following the pilot study and with the agreement of the trial steering committee. The Primary outcomes are now: 1. Visual acuity less then 6/18 in either eye. 2. Visual function: the composite score on the national eye Institute Visual Function Questionnaire 25 Version.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/02/2000
Completion date	12/06/2002

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target number of participants	2000
Key inclusion criteria	The trial is being conducted in practices involved in the MRC Trial of Assessment and Management of Elderly People in the Community (The Elderly Screening Trial), who were recruited through the MRCGP framework. The patient population included all patients aged 75 years and over registered with study practices at the start of the main trial (1995-1997). We propose to re-examine 2000 participants from 20 practices within the main trial (100 in each practice). We will randomly select 10 practices from the two arms of the main trial. Within each practice, we will then randomly sample 150 people from the list of people who were originally eligible for inclusion in the main Elderly Screening Trial. We will ascertain those participants who have died or moved away. The remaining participants will be invited to an assessment.
Key exclusion criteria	Anyone in long-term care or with terminal disease.
Date of first enrolment	01/02/2000
Date of final enrolment	12/06/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Epidemiology Unit

London
WC1E 7HT
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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?
Results article	results	01/07/2002		Yes	No
Results article	results	01/03/2004		Yes	No