Contact information
Type
Scientific
Primary contact
Dr Liam Smeeth
ORCID ID
Contact details
Epidemiology Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7636 8636
liam.smeeth@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9900232
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/02/2000
Overall trial end date
12/06/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
2000
Participant exclusion criteria
Anyone in long-term care or with terminal disease.
Recruitment start date
01/02/2000
Recruitment end date
12/06/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Epidemiology Unit
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list
1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12084753
2. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14977771
Publication citations
-
Results
Evans JR, Fletcher AE, Wormald RP, Ng ES, Stirling S, Smeeth L, Breeze E, Bulpitt CJ, Nunes M, Jones D, Tulloch A, Prevalence of visual impairment in people aged 75 years and older in Britain: results from the MRC trial of assessment and management of older people in the community., Br J Ophthalmol, 2002, 86, 7, 795-800.
-
Results
Evans JR, Fletcher AE, Wormald RP, , Causes of visual impairment in people aged 75 years and older in Britain: an add-on study to the MRC Trial of Assessment and Management of Older People in the Community., Br J Ophthalmol, 2004, 88, 3, 365-370.