| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN96973836 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0141187718 |
| Public title | Pilot RCT of posturing following surgery for macular hole |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Eye Diseases: Macular hole |
| Study hypothesis | 1. To estimate variance and effect size in order to inform power calculations that will determine the design and size of a future study
2. To estimate recruitment and therefore duration of a future study
3. To establish procedures and protocols for the future study |
| Design/methodology | Pilot randomised controlled study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients listed for surgery for idiopathic full thickness macular hole
2. Able and willing to posture face down for 10 days postoperatively
3. Agree to participate in the trial and give informed consent |
| Participants - exclusion criteria | 1. History of visual loss suggesting a duration of macular hole > 12 months
2. Patients unwilling or unable to posture face down for 10 days postoperatively
3. History of trauma which may have been causative
4. Age less than 18 years old in UK or less than 16 years old in Scotland
5. Previous vitrectomy surgery |
| Patient information material |
|
| Anticipated start date | 15/11/2006 |
| Anticipated end date | 15/11/2007 |
| Status of trial | Completed |
| Target number of participants | 30 |
| Interventions | 1. Posture face down for 50 minutes in every hour for the first 10 days after operation
2. Not to maintain specific posture, except avoid face up posture |
| Primary outcome measure(s) | 1. Variance and effect size to inform power calculation for a full study
2. Recruitment rate
3. Establish procedures and protocols |
| Secondary outcome measure(s) | 1. Macular hole closure
2. Visual acuity
3. Complications
4. Differences in answer to patient survey questions between the 2 groups |
| 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 W Luke Membrey |
| Contact details | Moorfields Eye Hospital
162 City Road
London
United Kingdom
EC1V 2PD |
| Contact telephone | +44 020 7566 2059 |
| Contact fax | +44 020 7566 2059 |
| Contact email | Luke.Membrey@moorfields.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN96973836 |
| Date last extracted from ISRCTN register | 17/04/2008 |
