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Original Investigation
November 12, 2020

Diagnostic Test Accuracy of the Red Reflex Test for Ocular Pathology in Infants: A Meta-analysis

Author Affiliations
  • 1Department of Ophthalmology, Rigshospitalet-Glostrup, Glostrup, Denmark
  • 2Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
JAMA Ophthalmol. 2021;139(1):33-40. doi:10.1001/jamaophthalmol.2020.4854
Key Points

Question  What is the diagnostic accuracy of the red reflex test for detecting ocular pathologies in infants?

Findings  In this systematic review and meta-analysis including 5 studies of 8713 patients, the red reflex test had a low sensitivity and a high specificity for detecting ocular pathologies.

Meaning  When screening infants, an abnormal red reflex test result is highly indicative of an ocular pathology, but a normal red reflex result does not rule out ocular pathologies.

Abstract

Importance  Red reflex testing is a simple and inexpensive method implemented in many countries as an important part of infant screening for ocular pathologies.

Objectives  To review the literature on the diagnostic accuracy of the red reflex test in infant screening for ocular pathologies and to perform meta-analyses to provide summary estimates.

Data Sources  The following literature databases were searched for English-language, peer-reviewed literature, published until April 19, 2020: Cochrane Central, PubMed/MEDLINE, Embase, Web of Science Core Collection, BIOSIS Previews, Current Contents Connect, Data Citation Index, Derwent Innovations Index, KCI-Korean Journal Database, Russian Science Citation Index, SciELO Citation Index, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and ClinicalTrials.gov.

Study Selection  Eligibility criteria were defined according to population (studies of consecutively screened infants), exposure (red reflex or Brückner test as the index test), comparator (any ophthalmological examination), and study type (any study with diagnostic test accuracy data).

Data Extraction and Synthesis  The Preferred Reporting Items for Systematic Reviews and Meta-Analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) guidelines were followed. Data were extracted independently by 2 authors. For summary estimates of diagnostic test accuracy, the hierarchical summary receiver operating characteristics curve was used. Prevalence of ocular pathologies was introduced for a prevalence meta-analysis, which was then used in calculations of diagnostic accuracy of the red reflex test when applied in infant screening.

Main Outcomes and Measures  True-positive, false-positive, true-negative, and false-negative findings; sensitivity; specificity; and positive and negative predictive values.

Results  In this meta-analysis, 8713 unique infants from 5 unique studies were eligible for qualitative and quantitative review. All studies used the red reflex test without pupillary dilation and were compared with a reference test performed with pupillary dilation. For any ocular pathology, an estimated sensitivity of 7.5% (95% CI, 7.4%-7.5%) and specificity of 97.5% (95% CI, 97.5%-97.5%) was found. Focusing on ocular pathologies that required a medical or surgical intervention, sensitivity improved to 17.5% (95% CI, 0.8%-84.8%) and specificity remained high at 97.6% (95% CI, 87.7%-99.6%).

Conclusions and Relevance  These findings suggest that an abnormal red reflex finding most likely reflects an underlying ocular pathology. However, a normal red reflex finding during screening does not exclude ocular disease.

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    2 Comments for this article
    EXPAND ALL
    A frugal yet effective way to deliver eye screening in low resource settings: The Arclight direct ophthalmoscope
    Andrew Blaikie, MBChB FRCOphth (UK) | University of St Andrews, School of Medicine, Global Health Division, St Andrews, Scotland, KY16 9TF
    The meta-analysis by Subhi et al (1) is a timely reminder that the ‘red reflex’ test is a simple yet effective means to screen for eye disease in early childhood. While routinely performed in wealthier settings it is rarely performed in low and middle income countries (LMICs) where the burden of blindness is greatest. Sadly in LMICs almost no health care workers at the mid or community level have access to a direct ophthalmoscope (DO) necessary to perform this test effectively. The Arclight DO has however been developed to address this lack of access to equipment; it is inexpensive, solar-powered, and independent of costly and hard-to-find batteries and bulbs.

    Despite its simplified design, it has been reported to have similar performance to more expensive devices amongst a range of health care workers training in Malawi (2). Importantly, in a study from Tanzania (3), sensitivity of 92.7% and specificity of 96.7% was achieved with a larger scale feasibility study concluding that “Arclight red reflex screening by Reproductive & Child Health nurses is feasible, as well as being both sensitive and specific”.

    To further strengthen and encourage successful acquisition of hands-on skills realistic simulation teaching eyes and an inter-professional education (IPE) programme have also been refined. Recent evaluation in Rwanda (4) indicated the Arclight package to be a suitable vehicle for promoting collaborative eye health practice amongst clinical officers, nurses and medical students. While face to face training and assessment will always be the gold standard, remote teaching using video conferencing platforms in the COVID-19 era can also be delivered exploiting the ease of use and portability of the Arclight and simulation training tools (5).

    Based on our experience could we also propose that the term 'red reflex test', although widely recognized, be updated to a potentially more accurate and racially equitable 'fundus reflex test'. This term better takes into account the wide range of eye pigmentation types that lead to variations in color and brightness: the appearance in normal babies in Africa, as well as Asia, is rarely red tending instead to be orange/yellow and sometimes white. This current default to a term more accurate for the appearance, on average, in eyes from individuals of European ancestry creates challenges when teaching, as well as confusion in practise.

    References

    1. Subhi Y, Schmidt DC, Al-Bakri M, Bach-Holm D, Kessel L. Diagnostic Test Accuracy of the Red Reflex Test for Ocular Pathology in Infants: A Meta-analysis. JAMA Ophthalmol. November 2020:1-7. doi:10.1001/jamaophthalmol.2020.4854
    2. Tuteja SY, Blaikie A, Kekunnaya R. Identification of Amblyogenic Risk Factors with the Brückner Reflex Test using the low-cost ‘Arclight’ Direct Ophthalmoscope. Eye. In Press.
    3. Mndeme FG, Mmbaga BT, Kim MJ, et al. Red reflex examination in reproductive and child health clinics for early detection of paediatric cataract and ocular media disorders: cross-sectional diagnostic accuracy and feasibility studies from Kilimanjaro, Tanzania. Eye. 2020. doi:10.1038/s41433-020-1019-5
    4. Carroll VO, Sagahutu JB, Ndayambaje D, Kayiranga D, Kitema GF, Rujeni N. Evaluation of a pilot interprofessional Arclight TM workshop for healthcare students in Rwanda : promoting collaborative practice in eye health. J Interprof Care. 2020;00(00):1-4. doi:10.1080/13561820.2020.1782356
    5. Joseph M, Obaid H. Comment on : Reshaping ophthalmology training after COVID-19 pandemic. Eye. 2020:19-21. doi:10.1038/s41433-020-01139-9
    CONFLICT OF INTEREST: AB is a part-time employee of the University of St Andrews. The University owns a social enterprise subsidiary company which sells Arclights to users in high resource countries. All profits are used to fund distribution and education exercises of the device in low income countries via the University’s Global Health Division. AB does not benefit directly or indirectly financially from these sales but acknowledges the common relationship between his employer and the social enterprise.
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    Comment on Diagnostic Test Accuracy of the Red Reflex Test for Ocular Pathology in Infants A Meta-analysis
    Thiago Martins |
    To the editor:

    In the response to the article titled “Diagnostic Test Accuracy of the Red Reflex Test for Ocular Pathology in Infants A Meta-analysis,” I would like to raise few points.
    The article concluded that an abnormal red reflex finding most likely reflects an underlying ocular pathology. However, a normal red reflex finding during screening does not exclude ocular disease.1

    I believe the red reflex test has greater sensitivity for detecting pathologies of the anterior segment than of the posterior segment of the newborn. Most abnormalities of the fundus of the eye involving retinal pigmentary abnormalities, vascular
    abnormalities, hemorrhage, and exudative pathology were often not detected by the red reflex exam.2


    I believe training of pediatric teams can be accomplished with the use of low-cost models, which allow the simulation of changes in the anterior and posterior segment of the newborn. The models can be constructed using cardboard and using an acrylic sphere and photographs of pathologies that simulate pathologies in the newborn. The acrylic sphere can be replaced by simulating opacities in the newborn's cornea and lens3.
    Proper teaching of this exam might help to avoid preventable causes of childhood blindness, which can have a great economic impact on society due to the long-life expectancy of these patients.


    FUNDING/SUPPORT: none
    FINANCIAL DISCLOSURES: none

    REFERENCES


    1. Subhi Y, Schmidt DC, Al-Bakri M, Bach-Holm D, Kessel L. Diagnostic Test Accuracy of the Red Reflex Test for Ocular Pathology in Infants: A Meta-analysis. JAMA Ophthalmol. 2020 Nov 12:e204854. doi: 10.1001/jamaophthalmol.2020.4854. Epub ahead of print. PMID: 33180103; PMCID: PMC7662495.
    2. Sun M, Ma A, Li F, Cheng K, Zhang M, Yang H, Nie W, Zhao B. Sensitivity and Specificity of Red Reflex Test in Newborn Eye Screening. J Pediatr. 2016 Dec;179:192-196.e4. doi: 10.1016/j.jpeds.2016.08.048. Epub 2016 Sep 15. PMID: 27640356.
    3. Dos Santos Martins TG, de Azevedo Costa ALF, Martins RV, Schor P. A Teaching Model for the Bruckner Test: Improving Screening for Congenital Cataract. Insight. 2017; 42(1):33-34.
    CONFLICT OF INTEREST: None Reported
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