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ISRCTN
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ISRCTN82666926
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ClinicalTrials.gov identifier
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Public title
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A randomised prospective study to evaluate laser peripheral iridotomy with YAG laser against sequential argon-YAG laser in dark irides
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0141184531
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Study hypothesis
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To identify the advantages of combined argon-YAG laser iridotomy versus YAG laser alone, in patients of darkly pigmented irides.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Eye Diseases: Pigmentation disorders
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Participants - inclusion criteria
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1. Require iridotomy in both eyes
2. Informed consent available
3. Can follow up after 3 months
4. Dark irides
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Participants - exclusion criteria
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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
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Anticipated start date
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23/08/2006
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Anticipated end date
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22/01/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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30
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Interventions
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Randomised controlled study
1. Pure YAG laser
2. Argon-YAG Laser
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Primary outcome measure(s)
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Total YAG laser power utilised
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Secondary outcome measure(s)
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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
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Sources of funding
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Moorfields Eye Hospital NHS Foundation Trust
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Julian
DeSilva
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Address
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Moorfields Eye Hospital
162 City Road
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City/town
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London
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Zip/Postcode
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EC1V 2PD
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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06/11/2007
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Date ISRCTN assigned
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28/09/2007
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