Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
20/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22161423

Publication citations

  1. 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.

Additional files

Editorial Notes