Condition category
Eye Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/03/2008
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

Mr A Foss

ORCID ID

Contact details

Health Care of the Elderly
A Floor
East Block
University Hospital
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes