Pilot RCT of posturing following surgery for macular hole

ISRCTN	ISRCTN96973836
DOI	https://doi.org/10.1186/ISRCTN96973836
Protocol serial number	N0141187718
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Moorfields Eye Hospital NHS Foundation Trust, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr W Luke Membrey
Scientific

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom

Phone	+44 (0)20 7566 2059
Email	Luke.Membrey@moorfields.nhs.uk

Primary study design	Interventional
Study design	Pilot randomised controlled study
Secondary study design	Randomised controlled trial
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(s)	1. Variance and effect size to inform power calculation for a full study 2. Recruitment rate 3. Establish procedures and protocols
Key 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
Completion date	15/11/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Moorfields Eye Hospital

London
EC1V 2PD
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/12/2011		Yes	No