The emotional impact of restoring sight
| ISRCTN | ISRCTN16721218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16721218 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 356506 |
| Protocol serial number | Nil known |
| Sponsor | University College London |
| Funders | Medical Research Foundation, Moorfields Eye Charity |
- Submission date
- 14/03/2025
- Registration date
- 27/03/2025
- Last edited
- 02/09/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
More treatment options than ever before are available for young people with vision impairment, but very little is known about the impact of these sight restoration therapies on wellbeing and mental health. In adults, sight restoration is often associated with depression and a reduction in mental wellbeing.
The aim of this study is to fully understand the wellbeing and mental health of adolescents undergoing sight restoration therapy and will develop clinical guidelines for the psychological support of young people receiving this treatment.
Who can participate?
Children and adolescents (age 10-20 years) with vision impairment who are receiving treatment expected to improve their vision.
What does the study involve?
Completing age-appropriate questionnaires five times: before receiving sight restoration treatment, then 1, 3, 6 and 12 months after treatment. Participating in a short interview before treatment and at the final visit. Participants' parent(s)/carer(s) will also complete a questionnaire at each assessment and a short interview at the first and last assessment.
What are the possible benefits and risks of participating?
Benefits: This is an exploratory study and is not likely to directly benefit participants. However, if needed, participants will be referred or signposted to appropriate mental health services.
Risks: It is possible that some of the interview questions may raise uncomfortable issues for participants or their parents/carers. The researchers have well-established risk management protocols, written in conjunction with clinical psychologists, which have been used for similar studies to ensure appropriate signposting and referral for participants who express signs of mental ill-health, up to and including emergency care.
Where is the study run from?
UCL Institute of Ophthalmology, part of University College London, in association with Moorfields Eye Hospital, Great Ormond Street Hospital for Children, and the NIHR Moorfields Biomedical Research Centre (UK)
When is the study starting and how long is it expected to run for?
January 2025 to December 2027
Who is funding the study?
1. The Medical Research Foundation (UK)
2. Moorfields Eye Charity (UK)
Who is the main contact?
Michael Crossland, m.crossland@ucl.ac.uk
Contact information
Public, Scientific, Principal investigator
UCL Institute of Ophthalmology
11-43 Bath Street
London
EC1V 9EL
United Kingdom
 ORCID ID |
0000-0001-6833-6043 |
|---|---|
| Phone | +44 (0)2076086800 |
| m.crossland@ucl.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Longitudinal observational study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | The emotional impact of restoring sight (EIRS): well-being and mental health in children and adolescents receiving sight restoring therapy for eye disease |
| Study acronym | EIRS |
| Study objectives | This study will use mixed qualitative and quantitative research methods to understand how sight-restoring treatment (for example, gene therapy for inherited retinal disease) affects the wellbeing and mental health of young people with vision impairment. |
| Ethics approval(s) |
Not yet submitted, Ethics committee name not provided (Address not provided, City not provided, Zip/postal code not provided; Telephone number not provided; Email not provided), ref: Reference number not provided |
| Health condition(s) or problem(s) studied | Any eye disease causing bilateral vision impairment |
| Intervention | Participants will complete age-appropriate questionnaires to assess their mental health and wellbeing five times: before receiving sight restoration treatment, and 1, 3, 6 and 12 months after treatment. Before treatment and at the end of the study, participants will also complete a short qualitative interview. Participants' parent(s)/carer(s) will also complete a questionnaire at each assessment and a short interview at the first and last assessment. |
| Intervention type | Not Specified |
| Primary outcome measure(s) |
Mental wellbeing assessed using the Warwick Edinburgh Mental Wellbeing Scale at pre-treatment, months 1, 3, 6 and 12 |
| Key secondary outcome measure(s) |
1. Participation assessed using the Child and Adolescent Scale of Participation at pre-treatment, months 1, 3, 6 and 12 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient, Carer |
|---|---|
| Age group | Mixed |
| Lower age limit | 10 Years |
| Upper age limit | 20 Years |
| Sex | All |
| Target sample size at registration | 36 |
| Key inclusion criteria | 1. Young people aged 10-20 years 2. Meeting the ICD-11 criterion of having mild, moderate or severe vision impairment, or blindness, in their better eye 3. Receiving treatment intended to improve their visual function 4. With sufficient English comprehension to understand the age-appropriate questionnaires |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/01/2026 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
162 City Road
London
EC1V 2PD
United Kingdom
Great Ormond Street
London
WC1N 3JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Datasets generated and/or analysed during the current study will be made available upon request from Michael Crossland (m.crossland@ucl.ac.uk). To preserve the confidentiality of the participants, potentially identifiable data will be redacted. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/09/2025: The date of first enrolment was changed from 01/09/2025 to 01/01/2026.
14/03/2025: Study's existence confirmed by Medical Research Foundation.
