Pilot RCT of posturing following surgery for macular hole

ISRCTN ISRCTN96973836
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

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

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

Study information

Study designPilot randomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectives1. 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) studiedEye Diseases: Macular hole
Intervention1. 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 typeOther
Primary outcome measure1. Variance and effect size to inform power calculation for a full study
2. Recruitment rate
3. Establish procedures and protocols
Secondary outcome measures1. Macular hole closure
2. Visual acuity
3. Complications
4. Differences in answer to patient survey questions between the 2 groups
Overall study start date15/11/2006
Completion date15/11/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants30
Key inclusion criteria1. 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 criteria1. 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 enrolment15/11/2006
Date of final enrolment15/11/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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