| Title: |
Extended optical treatment versus early patching with an intensive patching regimen in children with amblyopia in Europe (EuPatch): a multicentre, randomised controlled trial |
| Authors: |
Proudlock, FA; Hisaund, M; Maconachie, G; Papageorgiou, E; Manouchehrinia, A; Dahlmann-Noor, A; Khandelwal, P; Self, J; Beisse, C; Gottlob, I; Mellors, A; Mallory, L; Teli, S; Sheth, V; Langmann, A; Bruce, A; Smith, A; Powell, C; Cross, M; North, L; Abbott, J; Mohan, M; Kafil-Hussain, N; Joseph, A; Webb, H; Redmill, B; Lawler, C; Sturm, V; Purohit, R; Gupta, M; Elliott, S; Mataftsi, A; Hamada, S; Evans, M; Hatebur, S; Hussain, S; Orr, J; Farooq, S; Osborne, D; Begum, F; Crofts, C; Pausch, F; Gaugl, H; Haug, J; Jones, R; Steinmair, K; Sharma, T; Hillier, S; Dent, M; Patel, S; Lienhart, A; Pennington, E; Maymond, S; Ludden, S; Zafeiropoulos, P; Asproudis, I; Tsironi, E; Scheitlin, C; Chauhan, M; Toor, S; Bennett, C; McPherson, C; Ramm, L; Bibi, M; Hussain, H; Samaddar, J; Shinh, R; Sarna, S; Amlani, K; Sauer, W; Kurt, A; Chung-Crossley, J; Ashraf, N; Tailor, V; Stewart, C |
| Source: |
The Lancet , 403 (10438) pp. 1766-1778. (2024) |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2024 |
| Collection: |
University College London: UCL Discovery |
| Description: |
Background: Amblyopia, the most common visual impairment of childhood, is a public health concern. An extended period of optical treatment before patching is recommended by the clinical guidelines of several countries. The aim of this study was to compare an intensive patching regimen, with and without extended optical treatment (EOT), in a randomised controlled trial. Methods: EuPatch was a randomised controlled trial conducted in 30 hospitals in the UK, Greece, Austria, Germany, and Switzerland. Children aged 3–8 years with newly detected, untreated amblyopia (defined as an interocular difference ≥0·30 logarithm of the minimum angle of resolution [logMAR] best corrected visual acuity [BCVA]) due to anisometropia, strabismus, or both were eligible. Participants were randomly assigned (1:1) via a computer-generated sequence to either the EOT group (18 weeks of glasses use before patching) or to the early patching group (3 weeks of glasses use before patching), stratified for type and severity of amblyopia. All participants were initially prescribed an intensive patching regimen (10 h/day, 6 days per week), supplemented with motivational materials. The patching period was up to 24 weeks. Participants, parents or guardians, assessors, and the trial statistician were not masked to treatment allocation. The primary outcome was successful treatment (ie, ≤0·20 logMAR interocular difference in BCVA) after 12 weeks of patching. Two primary analyses were conducted: the main analysis included all participants, including those who dropped out, but excluded those who did not provide outcome data at week 12 and remained on the study; the other analysis imputed this missing data. All eligible and randomly assigned participants were assessed for adverse events. This study is registered with the International Standard Randomised Controlled Trial Number registry (ISRCTN51712593) and is no longer recruiting. Findings: Between June 20, 2013, and March 12, 2020, after exclusion of eight participants found ineligible after detailed ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/10192321/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/10192321/1/1-s2.0-S0140673623028933-main.pdf; https://discovery.ucl.ac.uk/id/eprint/10192321/ |
| Rights: |
open |
| Accession Number: |
edsbas.75EF22B9 |
| Database: |
BASE |