Nationwide survey of prosthetic eye users
| ISRCTN | ISRCTN28123440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28123440 |
| Integrated Research Application System (IRAS) | 218611 |
| Protocol serial number | IRAS No 218611 |
| Sponsor | Queen Victoria Hospital |
| Funders | Queen Victoria Hospital, Institute of Maxillofacial Prosthetists and Technologists, Investigator initiated and funded |
- 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
| Primary study design | Observational |
|---|---|
| Study design | Observational cross sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| 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 |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
1. Incidence of anophthalmia is analysed using participant questionnaires |
| Key secondary outcome measure(s) |
There are no secondary outcome measures. |
| Completion date | 01/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 500 |
| 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
- United Kingdom
- England
Study participating centre
East Grinstead
RH19 3DZ
East Grinstead
RH19 3DZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
