Contact information
Type
Scientific
Primary contact
Mr W Luke Membrey
ORCID ID
Contact details
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
+44 (0)20 7566 2059
Luke.Membrey@moorfields.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0141187718
Study information
Scientific title
Acronym
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
Ethics approval
Not provided at time of registration
Study design
Pilot randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
15/11/2006
Overall trial end date
15/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30
Participant 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
Recruitment start date
15/11/2006
Recruitment end date
15/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Moorfields Eye Hospital NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22161423
Publication citations
-
Results
Solebo AL, Lange CA, Bunce C, Bainbridge JW, Face-down positioning or posturing after macular hole surgery., Cochrane Database Syst Rev, 2011, 12, CD008228, doi: 10.1002/14651858.CD008228.pub2.