Dataset Information

Effect of Eye Masks on Neonatal Stress Following Dilated Retinal Examination: The MASK-ROP Randomized Clinical Trial.

ABSTRACT: Importance:Although screening examinations for retinopathy of prematurity (ROP) prevent blindness, they are physiologically stressful for infants. Photosensitivity during mydriasis may contribute to postexamination stress, and reducing light stimulation may make infants more comfortable. Objective:To determine the effect of a phototherapy mask worn during mydriasis on infant stress in the 12-hour period following ROP screening. Design, Setting, and Participants:The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination (MASK-ROP) randomized clinical trial with patient recruitment from April 2016 to June 2017 at neonatal intensive care units at St Michael's Hospital and Sunnybrook Health Sciences Center in Toronto, Ontario, Canada. A consecutive series of infants with birth weight of less than 1500 g and/or gestational age of less than 32 weeks undergoing their first ROP screening were analyzed beginning in July 2017. Analysis was intention to treat. Interventions:Patients were randomized to wear a phototherapy mask for a minimum of 4 hours after dilating drop instillation in addition to standard comfort measures. Main Outcomes and Measures:Number of desaturation, bradycardic, or apneic events during the 12-hour postexamination period. Results:Of 51 infants who were examined, 28 (54.9%) were randomized to the treatment group (ie, used a mask) and 23 (45.1%) to the control group. Overall, 10 (35.7%) and 13 infants (56.5%) received ventilator support at the time of examination in the treatment and control groups, respectively. The mean (SD) gestational age was 27.9 (2.4) weeks, 32 (63%) were boys, and the mean (SD) birth weight was 1058.6 (312.0) g. The number of all stressful events were lower in the treatment group compared with controls in the 12-hour postexamination period, adjusted for events prior to examination and ventilation status (mean [95% CI] events,?1.0 [0.6-1.8] vs 1.7 [1.0-1.7]; rate ratio [RR],?0.57; 95% CI, 0.3-1.2; P?=?.12). Risk factors associated with increased stress included younger gestational age (RR,?1.32; 95% CI, 1.2-1.5 per week), lower birth weight (RR,?1.39; 95% CI, 1.2-1.5 per 100 g), ventilator support around the time of examination (RR,?2.67; 95% CI, 1.3-5.6), intraventricular hemorrhage (RR,?3.78; 95% CI, 1.9-7.3), and hyponatremia (RR,?3.42; 95% CI, 1.8-6.6). No adverse events occurred while using eye masks. Conclusions and Relevance:This randomized clinical trial found that light sensitivity may play a role in stress observed in the late postexamination period. However, unequal distribution of infants receiving ventilator support placed certain neonates at higher risk of stress, and the clinical significance of this intervention's benefit could not be concluded with confidence. Trial Registration:ClinicalTrials.gov identifier: NCT03824782.

SUBMITTER: Szigiato AA

PROVIDER: S-EPMC6735413 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Effect of Eye Masks on Neonatal Stress Following Dilated Retinal Examination: The MASK-ROP Randomized Clinical Trial.

Szigiato Andrei-Alexandru AA Speckert Matthew M Zielonka Jeanne J Hollamby Kathleen K Altomare Filiberto F Ng Eugene E Nisenbaum Rosane R Sgro Michael M

JAMA ophthalmology 20191101 11

<h4>Importance</h4>Although screening examinations for retinopathy of prematurity (ROP) prevent blindness, they are physiologically stressful for infants. Photosensitivity during mydriasis may contribute to postexamination stress, and reducing light stimulation may make infants more comfortable.<h4>Objective</h4>To determine the effect of a phototherapy mask worn during mydriasis on infant stress in the 12-hour period following ROP screening.<h4>Design, setting, and participants</h4>The Effect o ...[more]

PMID: 31486844

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Project description:ImportanceIn improving clinical outcomes, developing a sustainable, transformative care delivery model is important for accessible, efficient, low-cost, high-quality community-based imaging and diagnosis of retinal diseases.ObjectiveTo test the feasibility and accuracy of the remote diagnosis imaging model as a clinical screening tool to facilitate the identification of referable macular degeneration.Design, setting, and participantsA nonrandomized study of 159 patients was conducted in sites with a relatively high disease prevalence (Duke University Health System endocrinology clinic and 2 Duke University Health System assisted living centers in North Carolina). All patients underwent remote diagnosis imaging, defined as color fundus photography (CFP) and optical coherence tomography (OCT) of nondilated pupils, acquired by nonexpert imagers using a retinal imaging device located at the point of service. The criterion standard examination was defined as a traditional dilated eye examination performed by retinal specialists. Deidentified remote diagnosis images were graded for interpretability and presence of referable macular degeneration, defined as any condition requiring a retinal specialist attention. Data analysis was performed from November 20, 2015, to February 10, 2019.Main outcomes and measuresPrimary outcome was feasibility of the remote retinal imaging. Secondary outcomes were operational characteristics and diagnostic and referral accuracy.ResultsOf the 159 patients included in the study, the mean (SD) age of enrolled participants was 65 (17) years, with a female to male ratio of 1.3 to 1. Most patients were white (111 [69.8%]), 44 were black patients (27.7%), approximately 1% were Asian patients and Hispanic patients, and 2 patients declined to disclose their race/ethnicity. Thirty-five eyes (22.0%) were determined to require referral to the retinal specialist by criterion standard examination. Remote diagnosis image interpretability was better when OCT was used compared with CFP (241 [96.4%] vs 164 [65.6%]). Remote diagnosis had high diagnostic accuracy in identifying referable macular degeneration: OCT and CFP both had 94% sensitivity (95% CI, 84%-98%), and OCT had specificity higher than for CFP (93% [95% CI, 87%-96% ] vs 63% [95% CI, 53%-71%]). Substantial agreement was found between the criterion standard and OCT (κ = 0.83; 95% CI, 0.76-0.91; P < .001) and between the criterion standard and CFP (κ = 0.76; 95% CI, 0.64-0.87; P < .001). The nonvalidated patient satisfaction survey revealed that 122 participants (76.7%; mean score, 4.16; 95% CI, 3.98-4.35) preferred remote imaging over the standard care examination.Conclusions and relevanceRemote diagnosis imaging and a standard examination by a retinal specialist appeared equivalent in identifying referable macular degeneration in patients with high disease prevalence; these results may assist in delivering timely treatment and seem to warrant future research into additional metrics.

Project description:BackgroundSpontaneous retinal activity (SRA) is important during eye-specific segregation within the dorsal lateral geniculate nucleus (dLGN), but the feature(s) of activity critical for retinogeniculate refinement are controversial. Pharmacologically or genetically manipulating cholinergic signaling during SRA perturbs correlated retinal ganglion cell (RGC) spiking and disrupts eye-specific retinofugal refinement in vivo, consistent with an instructive role for SRA during visual system development. Paradoxically, ablating the starburst amacrine cells (SACs) that generate cholinergic spontaneous activity disrupts correlated RGC firing without impacting retinal activity levels or eye-specific segregation in the dLGN. Such experiments suggest that patterned SRA during retinal waves is not critical for eye-specific refinement and instead, normal activity levels are permissive for retinogeniculate development. Here we revisit the effects of ablating the cholinergic network during eye-specific segregation and show that SAC ablation disrupts, but does not eliminate, retinal waves with no concomitant impact on normal eye-specific segregation in the dLGN.ResultsWe induced SAC ablation in postnatal ferret pups beginning at birth by intraocular injection of a novel immunotoxin selective for the ferret vesicular acetylcholine transporter (Ferret VAChT-Sap). Through dual-patch whole-cell and multi-electrode array recording we found that SAC ablation altered SRA patterns and led to significantly smaller retinal waves compared with controls. Despite these defects, eye-specific segregation was normal. Further, interocular competition for target territory in the dLGN proceeded in cases where SAC ablation was asymmetric in the two eyes.ConclusionsOur data demonstrate normal eye-specific retinogeniculate development despite significant abnormalities in patterned SRA. Comparing our current results with earlier studies suggests that defects in retinal wave size, absolute levels of SRA, correlations between RGC pairs, RGC burst frequency, high frequency RGC firing during bursts, and the number of spikes per RGC burst are each uncorrelated with abnormalities in eye-specific segregation in the dLGN. An increase in the fraction of asynchronous spikes occurring outside of bursts and waves correlates with eye-specific segregation defects in studies reported to date. These findings highlight the relative importance of different features of SRA while providing additional constraints for computational models of Hebbian plasticity mechanisms in the developing visual system.

Dataset Information

Effect of Eye Masks on Neonatal Stress Following Dilated Retinal Examination: The MASK-ROP Randomized Clinical Trial.

Publications

Effect of Eye Masks on Neonatal Stress Following Dilated Retinal Examination: The MASK-ROP Randomized Clinical Trial.

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