Pupil dilation prior to cataract surgery with a pledget sponge - a randomised controlled trial.

ISRCTN	ISRCTN63768137
DOI	https://doi.org/10.1186/ISRCTN63768137
Secondary identifying numbers	N0280141214

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Austin McCormick
Scientific

Department of Opthamology
Arrowe Park Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Is pledget sponge soaked in dilating drops as effective as simple repeated drop administration in producing pupil dilation?
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Surgery: Cataract
Intervention	Randomised controlled trial. 1. Pledget sponge. 2. Repeated drop administration.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	tropicamide phenylepherine atropine
Primary outcome measure	Pupil diameter
Secondary outcome measures	Pain or discomfort on administration of drops or pledget assessed using a visual analogue scale
Overall study start date	01/05/2004
Completion date	01/08/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	80
Key inclusion criteria	Plan for 40 patients per group, on average 6 patients per list means approximately 14 lists, 2 Lists per week over 7 weeks.
Key exclusion criteria	Previous eye disease likely to cause a small pupil
Date of first enrolment	01/05/2004
Date of final enrolment	01/08/2004

Department of Opthamology

Wirral
CH49 5PE
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Hospital/treatment centre

Wirral Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2006		Yes	No