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 this study 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 study 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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2015 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26576755
2017 statistical analysis plan in: https://www.ncbi.nlm.nih.gov/pubmed/28610601