Topical direct laser pan retinal photocoagulation versus retrobulbar indirect laser photocoagulation - which is more comfortable to the patient?

ISRCTN	ISRCTN78721738
DOI	https://doi.org/10.1186/ISRCTN78721738
Secondary identifying numbers	N0203121465

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 15/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

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

Mr Vasant Raman
Scientific

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter, Devon
EX2 5BW
United Kingdom

Phone	+44 (0)1392 406033
Email	Vasant317@yahoo.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Topical direct laser pan retinal photocoagulation versus retrobulbar indirect laser photocoagulation - which is more comfortable to the patient?
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	23/12/2002
Completion date	31/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	23/12/2002
Date of final enrolment	31/03/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Devon & Exeter Hospital (Wonford)

Exeter, Devon
EX2 5BW
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Royal Devon and Exeter NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

15/04/2016: No publications found, verifying study status with principal investigator.