Nationwide survey of prosthetic eye users
| ISRCTN | ISRCTN28123440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28123440 |
| IRAS number | 218611 |
| Secondary identifying numbers | IRAS No 218611 |
- Submission date
- 22/03/2017
- Registration date
- 04/07/2017
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
Maxillofacial Prosthetics Dept
Queen Victoria Hospital
Holtye Road
East Grinstead
RH19 3DZ
East Grinstead
RH19 3DZ
United Kingdom
| Phone | +44 1342 414310 |
|---|---|
| emma.worrell@nhs.net |
Study information
| Study design | Observational cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | A nationwide survey of prosthetic eye users: A collaborative study with all NHS ocular prosthetic service providers |
| Study objectives | 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(s) | East of Scotland Research Ethics Service, 21/02/2017, ref: NRES 17/ES/0010 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/04/2017 |
| Completion date | 01/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 as a minimum sample size |
| Total final enrolment | 1185 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/07/2017 |
| Date of final enrolment | 31/05/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
East Grinstead
RH19 3DZ
East Grinstead
RH19 3DZ
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Office
Holtye Road
East Grinstead
East Grinstead
RH19 3DZ
England
United Kingdom
| Phone | +44 1342 414000 |
|---|---|
| sarah.dawe@qvh.nhs.uk | |
"ROR" |
https://ror.org/01ywpxj09 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | comfort and satisfaction results | 26/10/2020 | 23/09/2021 | Yes | No |
| Results article | demographics, comfort and satisfaction results | 05/09/2020 | 23/09/2021 | Yes | No |
| Results article | maintenance, management and quality of life results | 04/01/2021 | 23/09/2021 | Yes | No |
| Results article | visual function and quality of life results | 01/03/2021 | 23/09/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
23/09/2021: Publication reference added.
12/06/2019: Added total final enrolment.
10/06/2019: Dr Emma Worrell's email address has been updated.
22/09/2017: Internal review.
