Contact information
Type
Scientific
Primary contact
Mr Vasant Raman
ORCID ID
Contact details
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
Devon
EX2 5BW
United Kingdom
+44 (0)1392 406033
Vasant317@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0203121465
Study information
Scientific title
Topical direct laser pan retinal photocoagulation versus retrobulbar indirect laser photocoagulation - which is more comfortable to the patient?
Acronym
Study hypothesis
Which of the two treatment modalities, topical direct laser pan retinal photocoagulation and retrobulbar indirect pan retinal photocoagulation laser is more comfortable to the patient?
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
Condition
Surgery of the eye
Intervention
Randomised controlled trial. Patients undergoing laser treatment either after topical or retrobulbar anaesthesia will be given a visual pain analog score chart. They will be asked to score the pain perceived during the course of the treatment. They will also be given a pain analog score chart to score pain felt during the first 48 h following treatment and the need for taking analgesics. They will be provided with a stamped addressed envelope.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Do patients feel comfortable having pan retinal photocoagulation laser treatment after retrobulbar anaesthesia?
Study endpoints: to compare the subjective comfort between topical anaesthesia direct pan retinal photocoagulation laser, and retrobulbar anaesthesia indirect pan retinal photocoagulation laser.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
23/12/2002
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients will be selected from the waiting list for laser procedure. A letter will be sent out to them giving them information regarding the proposed research, and on the day of the laser they will be asked about their willingness to take part in the research. Case selection will be random. This is a non-therapeutic research. Patients will be over 16 years of age.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
23/12/2002
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter, Devon
EX2 5BW
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Devon and Exeter NHS Trust (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