ISRCTN ISRCTN22641495
DOI https://doi.org/10.1186/ISRCTN22641495
Secondary identifying numbers N0185146360
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
11/04/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Jean Middleton
Scientific

Accident & Emergency OPD Department
Royal Eye Infirmary
Dale Road
Mutley
Plymouth
PL4 6PL
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo identify what is best practice for removal of corneal rust, ensuring that patient care is not compromised.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedEye Diseases: Corneal damage
InterventionPatients 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 typeOther
Primary outcome measureAims & 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 measuresNot provided at time of registration
Overall study start date27/02/2003
Completion date28/02/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment27/02/2003
Date of final enrolment28/02/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Accident & Emergency OPD Department
Plymouth
PL4 6PL
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Plymouth Hospitals NHS Trust (UK), Own Account

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan