| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN82666926 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0141184531 |
| Public title | A randomised prospective study to evaluate laser peripheral iridotomy with YAG laser against sequential argon-YAG laser in dark irides |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Eye Diseases: Pigmentation disorders |
| Study hypothesis | To identify the advantages of combined argon-YAG laser iridotomy versus YAG laser alone, in patients of darkly pigmented irides. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Require iridotomy in both eyes
2. Informed consent available
3. Can follow up after 3 months
4. Dark irides |
| Participants - 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 |
| Patient information material |
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| Anticipated start date | 23/08/2006 |
| Anticipated end date | 22/01/2007 |
| Status of trial | Completed |
| Target number of participants | 30 |
| Interventions | Randomised controlled study
1. Pure YAG laser
2. Argon-YAG Laser |
| Primary outcome measure(s) | Total YAG laser power utilised |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Moorfields Eye Hospital NHS Foundation Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Julian DeSilva |
| Contact details | Moorfields Eye Hospital
162 City Road
London
United Kingdom
EC1V 2PD |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN82666926 |
| Date last extracted from ISRCTN register | 17/04/2008 |
