Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/04/2016
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 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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

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