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ISRCTN
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ISRCTN53474285
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DOI
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10.1186/ISRCTN53474285
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Screening the elderly for impaired vision: a nested trial within the MRC elderly trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9900232
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Primary care
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Anyone in long-term care or with terminal disease.
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Anticipated start date
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01/02/2000
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Anticipated end date
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12/06/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2000
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12084753
2. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14977771
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Contact name
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Dr
Liam
Smeeth
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Address
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Epidemiology Unit
London School of Hygiene and Tropical Medicine
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 8636
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Fax
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+44 (0)20 7436 5389
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Email
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liam.smeeth@lshtm.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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24/11/2010
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Date ISRCTN assigned
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23/10/2000
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