Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
08/09/2015
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 Julian DeSilva

ORCID ID

Contact details

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0141184531

Study information

Scientific title

A randomised prospective study to evaluate laser peripheral iridotomy with YAG laser against sequential argon-YAG laser in dark irides

Acronym

Study hypothesis

To identify the advantages of combined argon-YAG laser iridotomy versus YAG laser alone, in patients of darkly pigmented irides.

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Eye Diseases: Pigmentation disorders

Intervention

1. Pure YAG laser
2. Argon-YAG Laser

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Total YAG laser power utilised

Secondary outcome measures

1. Complications (iris haemorrhage, elevated intraocular pressure, intraocular inflammation, focal corneal opacity)
2. Patency of laser iridotomy after single treatment
3. Cost implications of 2 laser treatments versus need for failed iridotomy requiring a second treatment

Overall trial start date

23/08/2006

Overall trial end date

22/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Require iridotomy in both eyes
2. Informed consent available
3. Can follow up after 3 months
4. Dark irides

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30

Participant exclusion criteria

1. Previous failed laser iridotomy
2. History of previous intraocular pathology affecting iris morphology
3. Patients with only 1 functional eye or previous ACG
4. Patients with advanced glaucoma
5. Patients medically unfit for laser treatment

Recruitment start date

23/08/2006

Recruitment end date

22/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Moorfields Eye Hospital NHS Foundation Trust (UK), NHS R&D Support Funding

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