Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185146360
Study information
Scientific title
Acronym
Study hypothesis
To identify what is best practice for removal of corneal rust, ensuring that patient care is not compromised.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Eye Diseases: Corneal damage
Intervention
Patients will be randomly allocated 2 or 5 days using sealed envelopes.
The following will be undertaken: 1.Case History, 2.Visual Acuity, 3. Examination: Slit lamp bio microscopy 4. Check whether patient fits criteria, 5. ask patient to participate, give patient information sheet, obtain consent. 6. Nurse practitioner opens envelope to identify 2 or 5 days. 7. Size and depth of foreign body will be measured and documented. 8. Other signs, symptoms documented eg inflammation. 9. pain score 1-10 analogue scale 10. procedure of removal 11. measurement of rust remaining 12 treatment given i.e medication, whether padded 13, follow up appointment according to random allocation 14 repeat visits to follow above procedure 15 telephone call to be made if follow up appointment not attended.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Aims & Objectives: To identify what is the best practice for removal of cornea rust, ensuring that patient care is not compromised. To compare differences in discomfort felt by the patient and healing process of the cornea when visits are at 2 or 5 day intervals. Study endpoints: To compare ease and completion of removal of cornea rust.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
27/02/2003
Overall trial end date
28/02/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
27/02/2003
Recruitment end date
28/02/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Accident & Emergency OPD Department
Plymouth
PL4 6PL
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Plymouth Hospitals NHS Trust (UK), Own Account
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