Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBF 98XX7 (N0192080943)
Study information
Scientific title
Acronym
Study hypothesis
To determine whether cataract surgery reduces the risk of falls in 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
Treatment
Patient information sheet
Condition
Cataract surgery in elderly people
Intervention
Expedited versus routine cataract surgery
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Time to first fall
2. Mean fall frequency over 12 months after randomisation
3. Visual acuity
4. Visual disability (VF-14)
5. Barthel Index
6. London handicap scale
7. EuroQOL questionnaire
8. Formal and informal care costs
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/1999
Overall trial end date
01/10/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Female patients awaiting cataract surgery
2. Aged 75 - 85 years
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
400
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/1999
Recruitment end date
01/10/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Care of the Elderly
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Trent (UK)
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/18172067
Publication citations
-
Results
Datta S, Foss AJ, Grainge MJ, Gregson RM, Zaman A, Masud T, Osborn F, Harwood RH, The importance of acuity, stereopsis, and contrast sensitivity for health-related quality of life in elderly women with cataracts., Invest. Ophthalmol. Vis. Sci., 2008, 49, 1, 1-6, doi: 10.1167/iovs.06-1073.