Plain English Summary
Background and study aims
Patients who wear an ocular prosthesis (also known as an artificial eye) often suffer with dry eye symptoms. Up to 90% will also complain of socket discharge, many on a daily basis. No literature exists on their quality of life post eye loss or adapting to monocular vision. There is little data in the field of artificial eye care. A nationwide study could provide the data on current artificial eye patients, ranging from reason for eye loss through to experience on wearing their ocular prosthesis and finally any change in quality of life following eye loss. The aim of this study is to compare patient comfort and satisfaction existing ocular prosthesis users and collate data on prosthetic eye users.
Who can participate?
Adults aged 18 and older who wear a prosthetic eye attending any Eye Service.
What does the study involve?
Participants are asked to fill out an anonymous questionnaire while waiting for an outpatient appointment. The questionnaire will ask about their experience of their ocular prosthesis and related care. There is no follow up required.
What are the possible benefits and risks of participating?
There are no benefits or risks with participating.
Where is the study run from?
This study is being run by the Queen Victoria Hospital (UK) and takes place in any Eye service or National Health Service Maxillofacial Prosthetic Departments (UK).
When is the study starting and how long is it expected to run for?
April 2017 to August 2019
Who is funding the study?
1. Queen Victoria Hospital (UK)
2. Institute of Maxillofacial Prosthetists and Technologists (UK)
Who is the main contact?
Dr Emma Worrell
Trial website
Contact information
Type
Scientific
Primary contact
Dr Emma Worrell
ORCID ID
Contact details
Maxillofacial Prosthetics Dept
Queen Victoria Hospital
Holtye Road
East Grinstead
RH19 3DZ
East Grinstead
RH19 3DZ
United Kingdom
+44 1342 414310
emma.worrell@qvh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IRAS No 218611
Study information
Scientific title
A nationwide survey of prosthetic eye users: A collaborative study with all NHS ocular prosthetic service providers
Acronym
Study hypothesis
The aim of this study is to compare patient comfort and satisfaction existing ocular prosthesis users and collate data on prosthetic eye users.
Ethics approval
East of Scotland Research Ethics Service, 21/02/2017, ref: NRES 17/ES/0010
Study design
Observational cross sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Artificial eye users
Intervention
Participants are given anonymous questionnaires to fill out while they are waiting for their outpatient appointments. The questionniares are available to patients in all eye services (Ocular/Corneoplastic/Ophthalmology) or National Health Service Maxillofacial Prosthetic Departments. The questionnaires will ask about their ocular prosthesis and related care. The study runs until May 2019 and there is no follow up required. Questionnaires are collected by the research team and entered on study databases.
Intervention type
Device
Phase
Drug names
Primary outcome measures
1. Incidence of anophthalmia is analysed using participant questionnaires
2. Length of prosthetic eye use is analysed using a participant questionnaires
3. Length of ocular wear is analysed using participant questionnaires
4. Age of prosthesis is analysed using participant questionnaires
5. Cleaning regime is analysed using participant questionnaires
6. Lubricant use is analysed using participant questionnaires
7. Inflammation is analysed using participant questionnaires
8. Comfort is analysed using participant questionnaires
9. Discharge is analysed using participant questionnaires
10. Quality of life is analysed using participant questionnaires
Secondary outcome measures
There are no secondary outcome measures.
Overall trial start date
01/04/2017
Overall trial end date
01/08/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients wearing a prosthetic eye or cosmetic shell, attending any Eye Service (Ocular/Corneoplastic/Ophthalmology) or National Health Service Maxillofacial Prosthetic Departments.
2. Over 18 years of age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500 as a minimum sample size
Participant exclusion criteria
1. Patients under the age of 18 years of age
2. Patients not wearing a prosthetic eye (e.g. purely an eye conformer)
3. Patients who are unable to give their own consent, under Mental Capacity Act (MCA) 2005
Recruitment start date
07/07/2017
Recruitment end date
31/05/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Victoria Hospital
Holtye Road
East Grinstead
RH19 3DZ
East Grinstead
RH19 3DZ
United Kingdom
Sponsor information
Organisation
Queen Victoria Hospital
Sponsor details
Research and Development Office
Holtye Road
East Grinstead
East Grinstead
RH19 3DZ
United Kingdom
+44 1342 414000
sarah.dawe@qvh.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Queen Victoria Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Institute of Maxillofacial Prosthetists and Technologists
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To write a nationally agreed cleaning protocol or best practice document. The goal is to produce a simple and readily available leaflet for the clinical environment and a downloadable pdf available on each organisation’s website. This study hopes to improve patient’s artificial eye tolerance and reduce deposit build up, reduce symptoms of discharge, ultimately improving the patient experience. This evidence based research will inform and prepare any future new patients; whether through NHS clinics, GP surgeries or affiliated ocular organisations. In addition this research could be used as an update to the most commonly suggested book for adapting to monocular vision: ‘A singular view’ The art of seeing with one eye by Frank B. Brady, first published in 1972.
IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/08/2020
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary