Positioning in macular hole surgery
| ISRCTN | ISRCTN12410596 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12410596 |
| Secondary identifying numbers | 17966 |
- Submission date
- 11/02/2015
- Registration date
- 11/02/2015
- Last edited
- 08/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | NRES Committee London - Westminster, 09/01/2015, ref: 201514/LO/2061 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2014 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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) |
| Total final enrolment | 185 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2015 |
| Date of final enrolment | 01/04/2017 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
London
EC1V 2PD
United Kingdom
G12 0YN
United Kingdom
ME16 9QQ
United Kingdom
M13 9WL
United Kingdom
SR4 7TP
United Kingdom
E11 1NR
United Kingdom
Sponsor information
Hospital/treatment centre
162 City Road
London
EC1V 2PD
England
United Kingdom
"ROR" |
https://ror.org/03zaddr67 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/11/2015 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 13/06/2017 | No | No | |
| Results article | results | 01/07/2020 | 07/05/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/05/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
16/06/2017: Publication references added.
