Abstract
This study aims to assess the prevalence and characteristics of preterm infants with retinopathy of prematurity (ROP) treated outside the recommended guidelines. In this retrospective monocentric cohort, we included all premature children treated in our department for ROP by laser photoablation or anti-VEGF intravitreal injection. The main outcome was treatment of both eyes for ROP less severe than pre-threshold type 1, treated outside ETROP guidelines. A total of 114 children received treatment for ROP in our department, among whom 32 (28.1%) children received treatment for indications outside the ETROP guidelines for both eyes. The indications outside the guidelines were persistent stage 2 or 3 ROP that showed no evidence of regression after 41 weeks of corrected gestational age (11 children; 34.4%), pre-plus stage (11; 34.4%), difficulties in disease staging (7; 21.9%), type 2 ROP with plus disease (2; 6.2%), and treatment due to logistical difficulties (1; 3.1%; hospitalized in neonatal units hundreds of miles away from our department, with no fundus examination possible in the neonatal unit). To resume, in our cohort, 28.1% of children received treatment for ROP less severe than pre-threshold type 1 both eyes. The main indications for off-label treatment were the persistence of active ROP during follow-up and the presence of pre-plus-stage disease. Our data suggest the need to update ROP treatment criteria to reflect real-life practices. Additional studies are required in order to evaluate the long-term benefits and side effects of treatments outside the recommended indications, and to establish revised treatment guidelines.
Highlights
Over the past decade, the survival of preterm children has improved; these children remain vulnerable to neonatal complications—especially retinopathy of prematurity (ROP) [1,2,3]
The International Classification of Retinopathy of Prematurity (ICROP) 3rd edition (ICROP3) study brought some updates to the ROP nomenclature: the definition of a posterior zone II region that begins at the margin between zone I and zone II, a definition of aggressive ROP that can occur in larger preterm infants and beyond the posterior retina, and precise definitions of regression and reactivation [7]
The following data were collected: gestational age (GA), birth weight (BW), sex, ETROP stage, ICROP classification, corrected age at the time of treatment, type of the first treatment, number of laser impacts if laser ablation was performed, screening method—wide-angle imaging system (RetCam®, Clarity Medical Systems, Pleasanton, CA, USA) or indirect ophthalmoscopy—and distance in kilometers between home and Rothschild Foundation Hospital (RFH)
Summary
The survival of preterm children has improved; these children remain vulnerable to neonatal complications—especially retinopathy of prematurity (ROP) [1,2,3]. ROP is a vasoproliferative disorder of the retina that can have adverse visual consequences, with blindness being the most severe. The International Classification of Retinopathy of Prematurity (ICROP) provided a harmonized clinical classification for ROP [4]. The ETROP (Early Treatment of Retinopathy of Prematurity) study introduced the definition of “pre-threshold” type 1 ROP and “pre-threshold” type 2 ROP [5,6]. Treatment is indicated in “pre-threshold” type 1 ROP, while “pre-threshold” type 2 ROP requires close follow-up without treatment. The ICROP 3rd edition (ICROP3) study brought some updates to the ROP nomenclature: the definition of a posterior zone II region that begins at the margin between zone I and zone II, a definition of aggressive ROP that can occur in larger preterm infants and beyond the posterior retina, and precise definitions of regression and reactivation [7]
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