Extended optical treatment versus early patching with an intensive patching regimen in children with amblyopia in Europe (EuPatch): a multicentre, randomised controlled trial
Authors: Frank A Proudlock, Michael Hisaund, Gail Maconachie, Eleni Papageorgiou, Ali Manouchehrinia, Annegret Dahlmann-Noor, Payal Khandelwal, Jay Self, Christina Beisse, Irene Gottlob, Ashleigh Mellors, Lucy Mallory, Seema Teli, Viral Sheth, Andrea Langmann, Alison Bruce, Angie Smith, Christine Powell, Meriel Cross, Lorraine North, Joseph Abbott, Meyyammai Mohan, Namir Kafil-Hussain, Annie Joseph, Hilary Webb, Brian Redmill, Carly Lawler, Veit Sturm, Ravi Purohit, Mohit Gupta, Sue Elliott, Asimina Mataftsi, Samer Hamada, Megan Evans, Simone Hatebur, Shazia Hussain, Julie Orr, Shegufta Farooq, Daniel Osborne, Farzana Begum, Catherine Crofts, Franziska Pausch, Heike Gaugl, Jennifer Haug, Ruth Jones, Karin Steinmair, Tina Sharma, Stephanie Hillier, Michelle Dent, Selina Patel, Anna Lienhart, Emma Pennington, Sian Maymond, Siobhán Ludden, Parakevas Zafeiropoulos, Ioannis Asproudis, Evangelia Tsironi, Caroline Scheitlin, Monica Chauhan, Sonia Toor, Carolyn Bennett, Charlie McPherson, Laura Ramm, Mashal Bibi, Hafsah Hussain, Julie Samaddar, Raadhika Shinh, Sachi Sarna, Kavita Amlani, Wiebke Sauer, Andrea Kurt, Jenny Chung-Crossley, Nabila Ashraf, Vijay Tailor, Catherine Stewart
Journal: The Lancet (2024)

BackgroundAmblyopia, 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.MethodsEuPatch 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.FindingsBetween June 20, 2013, and March 12, 2020, after exclusion of eight participants found ineligible after detailed screening, we randomly assigned 334 participants (170 to the EOT group and 164 to the early patching group), including 188 (56%) boys, 146 (44%) girls, and two (1%) participants whose sex was not recorded. 317 participants (158 in the EOT group and 159 in the early patching group) were analysed for the primary outcome without imputation of missing data (median follow-up time 42 weeks [IQR 42] in the EOT group vs 27 weeks [27] in the early patching group). 24 (14%) of 170 participants in the EOT group and ten (6%) of 164 in the early patching group were excluded or dropped out of the study, mostly due to loss to follow-up and withdrawal of consent; ten (6%) in the EOT group and three (2%) in the early patching group missed the 12 week visit but remained on the study. A higher proportion of participants in the early patching group had successful treatment (107 [67%] of 159) than those in the EOT group (86 [54%] of 158; 13% difference; p=0·019) after 12 weeks of patching. No serious adverse events related to the interventions occurred.InterpretationThe results from this trial indicate that early patching is more effective than EOT for the treatment of most children with amblyopia. Our findings also provide data for the personalisation of amblyopia treatments.FundingAction Medical Research, NIHR Clinical Research Network, and Ulverscroft Foundation.