Condition category
Eye Diseases
Date applied
22/03/2017
Date assigned
04/07/2017
Last edited
22/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes

22/09/2017: Internal review.