Condition category
Eye Diseases
Date applied
11/02/2015
Date assigned
11/02/2015
Last edited
23/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A macular hole is a small gap that occurs at the centre of the retina (a thin light-sensitive layer of tissue lining the inner surface of the eye). The condition causes sight loss in approximately 2 in every 1000 individuals and can have a devastating impact on quality of life and independence. The condition is believed to result from pulling on the retina by the vitreous gel that fills the eye. It is treated by surgical removal of the vitreous gel to relieve these forces, and injection of a gas bubble to help close the hole. Following surgery, patients may be advised to maintain a face-down position (with the eyes directed straight down) for up to 10 days. This aims to improve the likelihood of the hole closing successfully by maintaining contact of the gas bubble with the macular hole. However, face-down positioning can be uncomfortable and we do not know if it is actually required to ensure a successful outcome. The aim of the proposed research is to determine the value of the advice to position face-down following surgery for large macular holes.

Who can participate?
Adults (aged over 18) diagnosed with a large macular hole.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are advised to position themselves face-down for 8 hours a day for 5 days. Those in group 2 are advised to adopt in inactive face-forward position for a similar period.

What are the possible benefits and risks of participating?
The trial will benefit patients by providing reliable information on the value of positioning following surgery for large macular holes, thereby enabling them to make an appropriately informed choice about the management of their condition.

Where is the study run from?
Moorfields Eye Hospital NHS Foundation Trust (lead centre) and 5 other NHS hospitals in the UK.

When is the study starting and how long is it expected to run for?
November 2014 to December 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr James Bainbridge

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Bainbridge

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17966

Study information

Scientific title

A multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning with an inactive face-forward position on the outcome of surgery for large macular holes.

Acronym

Study hypothesis

The aim of the proposed research is to determine the value of advice to position face-down following surgery for large macular holes.

Ethics approval

NRES Committee London - Westminster, 09/01/2015, ref: 201514/LO/2061

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Ophthalmology; Subtopic: Eye (all Subtopics); Disease: Ophthalmology

Intervention

Positioning in macular surgery. The intervention is advice to position face-down following surgery for a total of at least 8 consecutive or non consecutive hours daily for 5 days. The comparison is advice to maintain an inactive face-forward position following surgery for a total of at least 8 consecutive or non consecutive hours a day for 5 days.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Anatomical closure of the macular hole.; Timepoint(s): Determined at three months after surgery by masked assessment of OCT scans.

Secondary outcome measures

To determine the impact of face-down positioning on sight, quality of life and wellbeing.

Overall trial start date

01/11/2014

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Presence of idiopathic full-thickness macular hole, greater than or equal to 400 µm in diameter as measured OCT
2. Patients electing to have surgery for macular hole, with or without simultaneous phacoemulsification and intra-ocular lens implant
3. Ability and willingness to position face-down or in an inactive faceforward position
4 Lower age limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 192; UK Sample Size: 192; Description: 192 patients in total, 96 in each arm of the study (SS incorporates 10% loss to follow up -min. requirement 86 per arm, 172 in total)

Participant exclusion criteria

1. Age-related macular degeneration; glaucoma; diabetic retinopathy; retinal degeneration; amblyopia; previous vitrectomy surgery (refractive error, lens opacity and previous use of ocriplasmin are not exclusion criteria)
2. Traumatic macular hole
3. History of visual loss suggesting macular hole duration longer than 12 months
4. Presence of a retinal tear identified during surgery for which post operative positioning is advised

Recruitment start date

01/05/2015

Recruitment end date

01/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfields Eye Hospital NHS Foundation Trust (lead centre)
162 City Road
London
EC1V 2PD
United Kingdom

Trial participating centre

Gartnavel General Hospital
Glasgow
G12 0YN
United Kingdom

Trial participating centre

Maidstone Hospital
Kent
ME16 9QQ
United Kingdom

Trial participating centre

Manchester Royal Eye Hospital
Manchester
M13 9WL
United Kingdom

Trial participating centre

Sunderland Royal Hospital
Sunderland
SR4 7TP
United Kingdom

Trial participating centre

Whipps Cross Hospital
London
E11 1NR
United Kingdom

Sponsor information

Organisation

Moorfields Eye Hospital NHS Foundation Trust

Sponsor details

162 City Road
London
EC1V 2PD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results will be disseminated at clinical meetings, and by publication in a peer-reviewed journal. A lay summary will be published on the trial website at: http://blizard.qmul.ac.uk/research-generation/870-macular-hole-positioning.html and should be available from summer 2017.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes