Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
28/08/2015
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 David Elliott

ORCID ID

Contact details

Department of Optometry
Richmond Building
University of Bradford
Bradford
BD7 1DP
United Kingdom
+44 (0)1274 234642
d.elliott1@bradford.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0050114598

Study information

Scientific title

Improvements in balance control, obstacle avoidance and step negotiation after cataract surgery.

Acronym

Study hypothesis

Does early cataract surgery improve balance control and mobility performance?

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

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Cataract

Intervention

The study will be a randomised clinical trial with subjects being placed into a group obtaining early surgery or one obtaining surgery at the usual time. The early surgery group will be tested before and after the operation, while the other group will be tested twice before surgery with the same test-retest time interval.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Power statistics have been used to determine subject numbers required. Between group comparisons of visual function, postural stability/control and mobility measures. An alpha level of P <0.05 will be used to determine statistical significant differences.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/07/2002

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients attending the Eye Clinic at Bradford Royal Infirmary, who suffer with cataracts will be asked by their treating consultant if they wish to take part.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

30/07/2002

Recruitment end date

30/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Optometry
Bradford
BD7 1DP
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Bradford Hospitals NHS Trust (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

Publication citations

Additional files

Editorial Notes