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As noted in the Description, this policy only addresses ocular photoscreening when performed in the primary care physician’s office, either as an adjunct or alternative to standard visual assessment. Aside from assessment of visual acuity using Snellen charts, letters, or other techniques, primary care physicians typically assess fixation and following movements and perform the red reflex test. Specifically, the red reflex test can detect visual opacities in the visual axis and abnormalities of the back of the eye, such as retinoblastoma or retinal detachment. When the red reflex is assessed simultaneously, potentially amblyopic conditions, such as asymmetric refractive errors and strabismus, can also be identified. The test is performed in a darkened room, with the direct ophthalmoscope focused on each pupil individually and then both eyes simultaneously. The family and clinical history may also identify a child at higher risk of amblyopia. For example, high-risk children include those with a family history of strabismus, amblyopia, high refractive errors, or childhood eye disorders. Children born prematurely, or those with neurologic and developmental conditions, are also at higher risk.
It is assumed that the results of photoscreening would be used to prompt referral to an ophthalmologist for further evaluation. Therefore, assessment of photoscreening in this setting requires population-based studies to determine whether the results of photoscreening result in a higher referral rate to ophthalmologists, with an associated improvement in sensitivity and specificity for detection of amblyogenic factors that lead to earlier diagnosis and treatment with a decrease in vision-impairing amblyopia. To date, these studies have not been performed.
The majority of the published studies have focused on the technical feasibility of ocular photoscreening, setting diagnostic parameters for interpretation of the photographs and its use in public health settings. For example, Tong and colleagues from the Wilmer Eye Institute published a series of three studies of the MTI PhotoScreener. The first study of 100 children was designed to determine whether or not healthcare professionals or lay volunteers could interpret and grade photoscreening photographs. A total of 18 volunteers including both pediatric ophthalmologists and lay personnel interpreted the photoscreening results, which included 26 children with normal ophthalmologic exams and 74 with abnormalities. Results from the graders varied, with sensitivities ranging from 37–88% and specificity from 40–80%. No single grader achieved both sensitivity and specificity greater than 70%. The authors concluded that these results reflected either inconsistent photographic interpretation skills or deficient grading criteria.
A subsequent study was published in 2000, which included 392 preverbal children who were referred to an ophthalmologist for examination; 103 had normal examination findings, while the remaining 284 children had conditions of interest for pediatric screening. In this study, the photographs were graded by a representative of the manufacturer, MTI PhotoScreener™, and the results compared with the results of the ophthalmologic exam. The overall sensitivity was 65% and the specificity 87%. The results were further analyzed according to the abnormality present, i.e., external examination abnormality (e.g., ptosis), media opacity, strabismus, and refractive error. The sensitivity for refractive error was low (33%), while the sensitivity for strabismus was 55%. The authors conclude that while photoscreening with the MTI system is promising, further research on grading criteria, particularly to detect refractive errors, is needed. The third study by the Wilmer Eye Institute investigated a new grading system for hyperopia, based on the conclusions from the previous study that the criteria for hyperopia indicating a failing grade were too low and would result in an undesirably high referral rate. This study re-examined the 392 photographs from the previous study and developed new grading criteria that resulted in a sensitivity and specificity of 100% and 88%, respectively.
Simons and colleagues studied the MTI PhotoScreener™ in 100 children, aged four months to twelve years, who were recruited either from a pediatric ophthalmologic referral practice or a day care center, or who were suspected to have developmental delay or a behavior disorder. All 100 photographs were independently graded by six observers, including four pediatric ophthalmologists, a nurse, and a research coordinator, and compared to the results of a complete ophthalmologic examination. For detecting any abnormal results, the sensitivity ranged from 80–91% and the specificity ranged from 20–67%. This study included verbal children, who presumably could participate in visual acuity tests.
It should be noted that all of the above studies recruited patients from a pediatric ophthalmology practice or other settings such that the studied population had a high incidence of patients with pathologic conditions. While these populations are useful to determine the initial sensitivity of photoscreening, this population does not duplicate the general population of children presenting to the primary care physicians’ office. Presumably, the patients in the above studies were referred to a pediatric ophthalmologist due to a clinical abnormality noted in the physical exam or a history that placed them at high risk. To determine the utility of photoscreening in the primary care physician’s office, the sensitivity and specificity of the photoscreening should be compared to the sensitivity and specificity of clinical diagnosis in this setting.
Ocular photoscreening has also been investigated in a public health care setting, where presumably the photoscreening is the only type of vision screening that is available to participants. For example, Donahue and colleagues reported on the results of a public health screening program that evaluated 15,000 preschool children in Tennessee. This program used volunteers from local Lions Clubs to take the photographs, and all photographs were interpreted at a central reading station by professional photo readers. The positive predictive value ranged from 84% when a diagnosis of strabismus was suggested by the photoscreen to 41% for astigmatism. While this public health setting is not applicable to this policy, it is anticipated that ocular photoscreening may be predominantly used in this setting.
In 2002, the American Academy of Pediatrics (AAP) published a commentary on photoscreening. This document noted the following:
- Photoscreening does not represent a single technique or piece of equipment. Different optical systems can be used for photoscreening. Interpretation of screened images may be performed in the physician's office, office in a reading center, or with an automated system.
- Each photoscreening system may have its own advantages and disadvantages, and it appears that results published in the literature for one system are not necessarily valid for others.
- It is difficult to compare efficacies of various vision-screening methods, such as stereoacuity testing, autorefraction, red reflex testing and cover testing, and then determine if photoscreening has better positive and negative predictive values. This is attributable in part to a lack of uniformity in pass-fail criteria for significant refractive errors.
- Photoscreening needs to be studied more extensively. The AAP favors additional research of photoscreening devices and other vision-screening methods in large, controlled studies to elucidate validity of results, efficacy, and cost effectiveness to identify amblyogenic factors in different age groups as well as subgroups of children.
In 2003, the AAP issued a policy statement on eye examination as performed by pediatricians, which included discussion of ocular photoscreening. This document noted that “photoscreening is not a substitute for accurate visual acuity measurement but can provide significant information about the presence of sight threatening conditions such as strabismus, refractive errors, media opacities (cataract) and retinal abnormalities (retinoblastoma). Photoscreening techniques are still evolving.”
In 2003, AAPOS published a position statement on photoscreening, which reads in part, “It is important to remember that photoscreening detects many problems that predispose the developing visual system to amblyopia, rather than providing a direct test of visual acuity and binocularity, and that, therefore these latter tests are preferable once a child can cooperate with such testing. For the preliterate child, however, photoscreening systems show significant potential. Current photoscreeners still suffer from relatively low sensitivity, high false positive referral rates, and relatively high usage costs. Advances in technology will eventually lead to the development of systems having higher sensitivities and positive predictive values. AAPOS encourages the development of such systems. We believe that further research may produce systems that have sufficient reliability to achieve widespread acceptance and usage, not only for children who do not receive primary medical care, but also in the primary care physician’s office.”
A literature search performed for the period of 2004 through July 2007 did not identify any additional published literature that would prompt reconsideration of the policy statement, which remains unchanged. The published literature continues to focus on settings other than the primary care physician’s office, i.e., a public health setting or an ophthalmology clinic. In 2005, a Cochrane review focused on the role of screening for amblyopia in general and noted that there have been no trials comparing the prevalence of amblyopia in screened vs. unscreened trials, therefore it is difficult to analyze the impact of screening programs on the prevalence of amblyopia. A single study was identified that examined the use of photoscreening in the primary care setting. Kemper and colleagues conducted a national survey of 377 pediatricians (55% response) to determine the rate of acuity screening in preschool children. It was reported that vision screening was conducted in 35%, 73%, and 66%, of three, four, and five-year olds, respectively. Few (8%) of the respondents reported using either autorefraction or photoscreening. Based on a retrospective review, Donahue reported that younger children with anisometropia had a lower prevalence of amblyopia than older children. This retrospective study, which should be considered preliminary, suggests that earlier detection of anisometropia might allow earlier intervention, and may prevent or retard development of amblyopia.
The National Eye Institute is sponsoring a three-phase multicenter prospective clinical trial to evaluate screening tests for identifying preschool children in need of comprehensive eye examinations. The category of screening personnel and the specific screening tests will be determined in Phases I and II of the “Vision in Preschoolers (VIP) Study”. Phase III will evaluate the performance (sensitivity and specificity) of the tests in identifying specific vision disorders in 6400 Head Start preschoolers.
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