Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/11/2014
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 J Innes

ORCID ID

Contact details

Hull Royal Infirmary
Ophthalmology Unit
Hull
HU3 2JZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084125075

Study information

Scientific title

To determine whether an eye shield is necessary following uncomplicated phacoemulsification cataract surgery

Acronym

Study hypothesis

To determine whether there are increased post-operative complications in patients using an eye shield.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised case controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Cataract

Intervention

The study group will be 75 patients with uncomplicated phacoemulsification in whom an eye shield will be used in the postop period over the operated eye. The shield will be used at night for a period of 1 week. The control group will comprise 75 patients with uncomplicated phacoemulsification with no eye shield for use in the postoperative period. A similar operative technique will be employed for each patient selected for this study. As far as possible the same anaesthetic technique will be used for each patient. Patients with coexisting or previous ocular pathology other than cataract will not be included.

Following surgery patients will be randomised to one of the two groups. Information will be gathered by standardised questionnaire administered by ophthalmic nursing staff one week after surgery during their routine post operative visit.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Outcome of surgery, patient questionnaire.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/06/2003

Overall trial end date

01/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Adults following cataract surgery uncomplicated by operative problems. Chosen randomly at preoperative assessment.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

150

Participant exclusion criteria

1. Intraoperative complications
2. Existing ocular pathology
3. Patients with one good seeing eye

Recruitment start date

19/06/2003

Recruitment end date

01/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The North and South Bank Research and Development Consortium (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