Condition category
Eye Diseases
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
24/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes