A randomised prospective study to evaluate laser peripheral iridotomy with YAG laser against sequential argon-YAG laser in dark irides
| ISRCTN | ISRCTN82666926 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82666926 |
| Secondary identifying numbers | N0141184531 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 12/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Julian DeSilva
Scientific
Scientific
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised prospective study to evaluate laser peripheral iridotomy with YAG laser against sequential argon-YAG laser in dark irides |
| Study objectives | To identify the advantages of combined argon-YAG laser iridotomy versus YAG laser alone, in patients of darkly pigmented irides. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Pigmentation disorders |
| Intervention | 1. Pure YAG laser 2. Argon-YAG Laser |
| Intervention type | Procedure/Surgery |
| 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 study start date | 23/08/2006 |
| Completion date | 22/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Require iridotomy in both eyes 2. Informed consent available 3. Can follow up after 3 months 4. Dark irides |
| Key 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 |
| Date of first enrolment | 23/08/2006 |
| Date of final enrolment | 22/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Moorfields Eye Hospital NHS Foundation Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2012 | Yes | No |
Editorial Notes
12/10/2017: Publication reference added.
