Comparison of QoL for children with treated & untreated RoP v1
Research type
Research Study
Full title
A comparison of Quality of Life for children with treated and untreated retinopathy of prematurity (version 1)
IRAS ID
299966
Contact name
Qasim Mansoor
Contact email
Sponsor organisation
South Tees Hospitals Foundation Trust
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
Retinopathy of Prematurity (RoP) is a disorder of retinal vessel growth associated with very premature birth, low birth weight and high exposure to oxygen. Depending on the stage of disease, it may self-resolve, or cause partial or total loss of vision secondary to retinal scarring and retinal detachment. It can also cause glaucoma, squints or lazy eye to develop. Premature babies are routinely screened and followed up accordingly, to assess if treatment, such as laser or eye injection is necessary.
This is a proposed cross sectional observational study involving children who were born at a gestational age of 23 (+0) - 26(+6) weeks between Jan 2014 – Dec 2015, and referred to the ophthalmology department in James Cook for screening for RoP. We will be using health-related quality of life (QoL) and vision-related QoL questionnaire data collected by a parent/guardian, as well as checking the most recent ophthalmological data available, with our primary outcome being a comparison in QoL between patients who received laser treatment and those who were assessed but did not require treatment for RoP. If there is no recent ophthalmological data, we will invite the family to attend for a visual assessment and orthoptic assessment for the child. By collaborating with the neonatal team at James Cook, we will also include the recorded neonatal/neurological data in our analysis.
This study is important to quantify the impact of treatment of RoP on QoL by comparing the treated and untreated cohorts, and is unique in comparing the latter two cohorts and in providing a more holistic overview than previous papers by incorporating both visual and health related QoL questionnaires, as well as neonatal and recent ophthalmological data, which will help towards a consensus in the literature. It will be conducted at James Cook University Hospital in Middlesbrough.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
21/SW/0165
Date of REC Opinion
6 Jan 2022
REC opinion
Further Information Favourable Opinion