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 to request a patient information sheet
Condition
Eye Diseases: Pigmentation disorders
Intervention
1. Pure YAG laser
2. Argon-YAG Laser
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/21515562