Low vs. high-intensity occlusion therapy for mild/moderate amblyopia
Research type
Research Study
Full title
Low vs. high-intensity occlusion therapy for mild/moderate amblyopia: A randomised, controlled feasibility trial
IRAS ID
266637
Contact name
Dipesh Patel
Contact email
Sponsor organisation
UCL GOS Institute of Child Health
ISRCTN Number
ISRCTN44138928
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
AIM
This study will compare low vs. high treatment doses for patching (occlusion therapy) children with lazy eye (amblyopia) to support the design of a future study.BACKGROUND
Amblyopia is a condition that affects about 230,000 children under 7 years in the UK. It affects the way eyesight develops, causing blurred vision. Treatment involves prescribing glasses, if required, and monitoring for improvement. In children whose vision does not correct fully with glasses alone, patching (covering the better-seeing or normal eye) is then commonly used.
Patching is often difficult for children and many suffer from bullying. Treatment is often unsuccessful.
2 hours daily patching (low-intensity treatment) usually takes a number of months, and sometimes years. Adherence to treatment drops dramatically over time.
High-intensity treatment could produce faster improvements, and better final outcomes, shortening treatment and reducing costs, but there isn’t enough information about the treatment to design a study comparing low to high-intensity patching.RESEARCH QUESTION
In children aged 4 years and older with amblyopia, does low or high-intensity patching produce a better vision outcome?
This study will provide the necessary information to address this question in a clinical trial.METHODS
We will:
1. Conduct a small-scale feasibility study to see if it’s possible to run a larger trial.
We will approach children and their families at Moorfields Eye Hospital to take part in the study. They will be randomly asked to perform either low or high-intensity patching. Treatment will be monitored with an electronic device in their patch. Children will have their vision tested in clinics for 12 months.2. Develop ways to address known problems with treatment adherence.
We will interview patients and their parents and work together with the public, psychologists and specialist implementation scientists to improve treatment adherence.3. Design a clinical trial and apply for funding.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/LO/0093
Date of REC Opinion
27 May 2020
REC opinion
Further Information Favourable Opinion