Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
22/09/2014
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 B Ilango

ORCID ID

Contact details

Wolverhampton Eye Infirmary
Cataract Surgery
Wolverhampton
WV10 0QP
United Kingdom
bilango@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0214181354

Study information

Scientific title

Acronym

Study hypothesis

What is the most comfortable and safest method for corneal protection after cataract surgery?

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

Eye diseases: cataract

Intervention

Eyepad vs eyeshield vs viscoelastic agent plus eyeshield in patients who have undergone cataract surgery.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Pain scores on first postoperative day
2. Corneal fluorescein staining on first postoperative day

Secondary outcome measures

Patient mobility and satisfaction in the post-operative period.

Overall trial start date

07/04/2006

Overall trial end date

07/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who have undergone eye surgery, undergoing uncomplicated phacoemulsification under local anaesthesia

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

1. Age < 18 years old
2. Difficulty in comprehension of study method or processes
3. Complicated cataract surgery
4. Pre-existing corneal disease
5. Corneal wound requiring suturing
6. Postoperative intraocular pressure of >25 mmHg
7. Greater than moderate anterior chamber reaction (+2 cells/flare) postoperatively

Recruitment start date

07/04/2006

Recruitment end date

07/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolverhampton Eye Infirmary
Wolverhampton
WV10 0QP
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

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

Funders

Funder type

Government

Funder name

The Royal Wolverhampton Hospitals NHS Trust (UK), RWHT in kind contribution, 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

Publication citations

Additional files

Editorial Notes