Pilot RCT of posturing following surgery for macular hole
ISRCTN | ISRCTN96973836 |
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DOI | https://doi.org/10.1186/ISRCTN96973836 |
Secondary identifying numbers | N0141187718 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 20/12/2011
- 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 W Luke Membrey
Scientific
Scientific
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
Phone | +44 (0)20 7566 2059 |
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Luke.Membrey@moorfields.nhs.uk |
Study information
Study design | Pilot randomised controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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 |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Eye Diseases: Macular hole |
Intervention | 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 |
Intervention type | Other |
Primary outcome measure | 1. Variance and effect size to inform power calculation for a full study 2. Recruitment rate 3. Establish procedures and protocols |
Secondary outcome measures | 1. Macular hole closure 2. Visual acuity 3. Complications 4. Differences in answer to patient survey questions between the 2 groups |
Overall study start date | 15/11/2006 |
Completion date | 15/11/2007 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 30 |
Key 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 |
Key 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 |
Date of first enrolment | 15/11/2006 |
Date of final enrolment | 15/11/2007 |
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 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Moorfields Eye Hospital NHS Foundation Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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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 | 07/12/2011 | Yes | No |