Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
23/07/2009
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 Austin McCormick

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0280141214

Study information

Scientific title

Acronym

Study hypothesis

Is pledget sponge soaked in dilating drops as effective as simple repeated drop administration in producing pupil dilation?

Ethics approval

Received from local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Cataract

Intervention

Randomised controlled trial.
1. Pledget sponge.
2. Repeated drop administration.

Intervention type

Drug

Phase

Not Specified

Drug names

tropicamide phenylepherine atropine

Primary outcome measures

Pupil diameter

Secondary outcome measures

Pain or discomfort on administration of drops or pledget assessed using a visual analogue scale

Overall trial start date

01/05/2004

Overall trial end date

01/08/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Previous eye disease likely to cause a small pupil

Recruitment start date

01/05/2004

Recruitment end date

01/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Opthamology
Wirral
CH49 5PE
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Wirral Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16925701

Publication citations

  1. Results

    McCormick A, Srinivasan S, Harun S, Watts M, Pupil dilation using a pledget sponge: a randomized controlled trial., Clin. Experiment. Ophthalmol., 2006, 34, 6, 545-549, doi: 10.1111/j.1442-9071.2006.01272.x.

Additional files

Editorial Notes