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GLAUCOMA IMAGE ANALYZERS IN PERSPECTIVE

There is now a cacophony of rhetoric on the whole issue of “structural and functional” assessment as it relates to the glaucoma diagnostic evaluation.  Very simply, scanning devices, such as the GDx-VCC, HRT, OCT, and RTA assess the structure of the optic nerve and/or retinal nerve fiber tissues, whereas visual field testing assesses the functional integrity of the optic nerve and visual pathway.

The big question is, when does one rely more on structural indices, and when does one rely more on functional indices?  There is a lot of overlap and a wide range of opinions regarding this issue.  Generally, it is felt that structural assessment has its forte in early detection, whereas once there is a repeatable visual field defect, it is probably best to follow these patients with visual field studies every 6 to 12 months.  Of course, if a patient progresses to a “repeatable” visual field defect,  reducing the IOP to a pachymetry-adjusted IOP of 12 to 14mmHg needs to be considered. The Advanced Glaucoma Intervention Study demonstrated a halt to measurable progression in disease when the IOP was held to about 12mmHg or lower.  Many such patients can achieve this through medical therapy; however,  many may require a trabeculectomy to achieve such a low target.

It is becoming clearer that the Frequency Doubling Technology and Short Wavelength Automated Perimetry may be able to detect visual field loss earlier than standard (white-on-white) automated perimetry (SAP).  Which then will be more sensitive for earlier detection - a structural scan or one of these enhanced perimetric techniques?  This distinction is not fully understood at this time, and even if it were, individual variability would always  be a potential confounder to any general consensus.

The glaucoma scanning technologies bring another piece to the diagnostic puzzle, and we are now comfortable with recommending that all optometrists acquire one of them as soon as it is feasible.  They are, however, of maximum diagnostic value when used within the context of a comprehensive glaucoma evaluation.  Used as a single piece of diagnostic data, their false-positive and false-negative results could cause the naïve clinician to either overtreat or undertreat many patients; similar to applanation tonometric readings that are not pachymetrically modified.  

The emergence of increasingly sophisticated diagnostic technologies is always welcome.  However, the old analogy comes to mind of watching a dog chase a car; what is he going to do with it if he ever catches it?  In a similar vein, it is crucial that we have a keen understanding of how to integrate any new and evolving technology in a manner that enhances patient care.  There are four, high-profile, image analyzer instruments available, and all of them can bring valuable adjunctive data into the decision-making milieu.  Unfortunately, these instruments are sometimes promoted with excessive zeal (by both the companies and lecturers). That over-exuberance has the potential for compromised patient care when relatively naïve doctors confer too much weight to the data obtained with any of these devices.  All scanning devices have limits to their sensitivity and specificity.  Therefore, both the structural and functional data obtained can be either immensely helpful or non-contributory, and at times, even misleading.  It is the astute clinician who has the wisdom to look at all the clinical  findings in proper perspective who provides excellent patient care. This is why we feel compelled to share the following perspective with you, our colleagues.

Just as the prostaglandins ushered in a new level of excitement in the treatment of glaucoma, the retina nerve fiber layer analyzers have ushered in a new level of excitement in the diagnosis of glaucoma. While these are indeed exciting new additions to our diagnostic armamentaria, they must be used appropriately.  The GDx-VCC, HRT, OCT, and RTA all have unique strengths and weaknesses, and all can bring greater diagnostic strength to the diagnostic work-up.  We feel the GDx-VCC is the overall best-valued instrument at this time, and the one we use in our clinical care.  We urge every optometrist to acquire one of these image analyzers, but exercise sound clinical judgment when integrating the data generated from these devices.  We urge you to carefully consider the following quotes and commentary so that you can integrate these technologies into your practices APPROPRIATELY.

  1. “The Gold Standard for diagnosing glaucoma is a well-trained clinician applying observational skills in the examination of the optic nerve, and interpreting examination findings in the clinical context of a particular patient.  Computerized imaging technology cannot substitute for sound clinical skills and judgment in the diagnosis of glaucoma.”

    “Structural changes in the optic nerve head may precede visual field abnormalities in early glaucoma.  These changes may be subtle and manifest themselves over many years.  Therefore, careful documentation of optic nerve structure at the time glaucoma is initially suspected will be extremely valuable in subsequently confirming or excluding a diagnosis of glaucoma during a patient’s lifetime.”

    “No instrument utilizing computerized imaging technology currently exists that has a sensitivity and specificity required to function as a useful screening tool for glaucoma.”

    “Documentation of optic nerve structure is of limited use in advanced glaucoma.  The diagnosis of advanced glaucomatous optic neuropathy is easily made by the trained observer, and does not require confirmation by optic nerve imaging studies.  Also, small changes in optic nerve topography are difficult to measure in the presence of advanced neuroretinal rim loss.  Functional assessment of the optic nerve head with visual field testing is more appropriate to assess disease progression in advanced glaucoma.”

    Reference
    Tanaka, G. H., Is Scanning Laser Imaging of the Optic Disc a Substitute For Stereo Disc Photography?, Glaucoma Subspecialty Day, American Academy of Ophthalmology, November 2003.

    M & T Commentary
    These four points nicely place this evolving technology in appropriate clinical perspective.  We urge you to acquire a scanning device, and use it wisely in evaluating all of your glaucoma suspects, as well as those with mild to moderate glaucoma. 

  2. “While OCT provides an objective measurement of nerve fiber layer structure, its clinical use in the early detection and follow-up of glaucoma patients requires additional clinical evaluation.  This author does not currently use this information to make important therapeutic decisions in patients at present.  Additional clinical correlation with existing techniques and prospective evaluations are required.”

    Reference
    Jaffe, G. J., and Caprioli, J., Perspective: Optical Coherence Tomography to Detect and Manage Retinal Disease and Glaucoma, AJO, January 2004.

    M & T Commentary
    This same exact statement applies to all scanning technologies and all visual field technologies. The evaluation of a patient suspected of having glaucoma is a complex, cerebral integration of numerous factors. These include age, race, family history, IOP, diurnal profile, central corneal thickness, optic nerve head status, gonioscopy, and visual field studies.  One must also consider the patient’s interest in being treated, ability to purchase eyedrops, instill eyedrops, willingness to return for follow-up care, etc.  Scanning image results are one component of this comprehensive evaluation, not a litmus test for glaucoma.

  3. “Regarding this entire category of devices, Dr. Ritch cautions that doctors shouldn’t depend on them too much. ‘I heard about a woman in her 40’s whose pressures, discs, and visual fields were normal.  She was treated with medications, laser, and nearly a trabeculectomy because of a defect found on a GDx test,’ “ he says.  ‘This is what you have to worry about, people using these instruments as gospel. They’re not.  They just supply more data for you to fit into the picture.’  Dr. Weinreb agrees.  ‘It’s important to place these tests in the context of an accurate and thorough clinical examination.  Basing treatment on information gleaned only from a single instrument test would be a misuse of the technology.  At the current time, they are meant to enhance an informed clinical examination, not to replace it.’ “

    Reference
    New Avenues in Glaucoma Diagnostics, Ophthalmology Management, August 2003.

    M & T Commentary
    Drs. Robert Ritch and Robert Weinreb are distinguished, internationally recognized, glaucoma experts, and we completely agree with their perspective.  As said earlier, we are thrilled to have our GDx-VCC, and appreciate its value as a COMPONENT of our diagnostic evaluation.

  4. “I think it’s extremely critical for ophthalmologists (M & Tx and optometric physicians) to have one of these devices in their offices,” said David S. Greenfield, M.D., associate professor, Bascom-Palmer Eye Institute, University of Miami, Florida. “These devices have the ability to quantitatively evaluate structures that could never before be quantitatively measured in a very user-friendly fashion.  While none of these technologies will replace visual field testing, their role is to provide additional, adjunctive information about structure that is complementary to the information generated with visual field testing.  Most glaucoma patients and eyes suspected to have early glaucomatous damage will benefit from having baseline and serial testing with ocular imaging.”

    M & T Commentary
    Dr. Greenfield is yet another highly regarded glaucoma expert, and indeed, has great expertise in imaging technology. 

    “The HRT, GDx, and OCT can HELP (emphasis added) determine which glaucoma patients require treatment and which can be monitored without treatment.”

    M & T Commentary
    The degree of this “help” will be relative to the numerous other factors in the diagnostic evaluation, i.e., is the diagnosis pretty clear-cut, or more borderline.  Obviously, the more borderline the diagnostic call, the keener one will have to look at all of the diagnostic data.

    Reference
    Incorporate Optic Nerve Head Imaging Into Your Practice, EyeWorld, December 2003.

  5. “Measurements of optic disc stereometric parameters by HRT is highly reproducible.  However, the use of retinal nerve fiber-related parameters should be taken cautiously.” 

    Reference
    Miglior, S. et al, Intraobserver and Interobserver Reproducibility in the Evaluation of Optic Disc Stereometric Parameter by Heidelberg Retina Tomograph, Ophthalmology, June 2002.

  6. “With structural tests, we have to recognize that there is no perfect instrument.  There wasn’t one in 1994, there isn’t one in 2003, and there won’t be one in 2010.  Every instrument, whether objective or subjective, has advantages and disadvantages.”

    Reference
    Weinreb, R. N, Weighing the Cost of Glaucoma Progression, Ophthalmology Management, August 2003.

  7. “In this study, HRT-based classification of ‘Glaucoma’ or ‘Normal’ was moderately sensitive, but not very specific when compared with the clinical impression as the Gold Standard.  Clinicians should not rely on the HRT diagnosis alone, but should use it to supplement the impression based on an eye examination and other ancillary tests.”

    Reference
    Kesen, M. R. et al, The Heidelberg Retina Tomagraph Versus Clinical Impression in the Diagnosis of Glaucoma, AJO, May 2002.

    M & T Commentary       
    While this article examined the HRT, its conclusions are equally valid for all of these image analyzers.  By the way, these technologies are exactly that - “image analyzers.”  However, you - the doctor - are the “patient analyzer;” please bear this critical distinction in mind!

  8. “There are two challenges to assessing the structure of the optic nerve.  The first is distinguishing between a normal and a glaucomatous optic nerve at a single point in time at any severity of disease.  This is obviously more difficult in mild disease.  However, the Gold Standard of performing this task is the well-trained clinician.  The ability of current imaging technology to allow the clinician to diagnosis glaucoma correctly on a single examination is not perfect, and its usefulness in this regard is of secondary importance.  The more important challenge is detecting glaucoma progression over time.  Scanning laser imaging of the optic nerve enhances, but does not replace good clinical skills in diagnosing glaucoma.  On a cautionary note, it is unsound clinical practice to base treatment decisions on a single-imaging study, and we must interpret imaging data in a clinical context.”

    Reference
    Tanaka, G. H., Stereo Disc Imaging Still Gold Standard for Glaucoma Imaging, Ophthalmology Times, 15 January 2004.

  9. We had the distinct privilege to attend the first global Association of International Glaucoma Society’s consensus meeting on “Structure and Function in the Management of Glaucoma” in San Diego, November 13-14, 2003.  The Optometric Glaucoma Society, of which we are members, is one of sixteen member societies of this worldwide body of glaucoma experts.  The following quote from page 90 of their printed program says:

    “There was general agreement that the current literature does not provide the requisite evidence to validate any of these imaging instruments for widespread, routine, clinical use, as the techniques have not been shown to be better than standard clinical testing, or a dilated examination from a trained clinician.  However, in the hands of an experienced clinician who understands the strengths and limitations of the instruments, information may be helpful in many clinical situations.  Unfortunately, it is unlikely that general ophthalmologists  (M & Txand probably optometric physicians, as well) examine the optic disc and/or nerve fiber layer with the same degree of expertise as a glaucoma sub-specialist.  In a recent survey of 395 US managed care patients, only 53% of patients received an optic disc photograph or drawing at their initial visit. ‘x it can be argued that imaging can be recommended as a routine clinical tool, as it will increase the assessment of the optic disc and retinal nerve fiber layer (RNFL) in the management of glaucoma.  However, x it is important to consider whether the cost of possible misinterpretation of results from imaging instruments to diagnosis glaucoma (and the possible overtreatment due to false positives) outweighs the benefits of providing optic disc and RNFL information to the general ophthalmologist and optometrist who would otherwise not assess the optic disc and RNFL of their glaucoma patients.’  “

  10. “Scanning computerized ophthalmic diagnostic imaging (SCODI) plays its least prominent role in advanced glaucomas.  By this stage, patients have definite evidence of perimetric damage. 

    “It’s still reasonable to utilize SCODI at baseline and again annually. The results of SCODI at this juncture are used not to alter the course of therapy, but rather to further bolster the case for stability or progression.”

    Reference
    Rabinowitz, A.,  Our Glaucoma Management Series Examines the Expanding Role of These Technologies, How They’re Being Used, and How to Document for Reimbursement, Part 2. Ophthalmology Management, May 2004.

    M & T Commentary
    We note how Dr. Rabinowitz stresses how these are not used, “to alter the course of therapy,” but rather, he views them as an adjunct to determining whether the patient’s advanced glaucoma is stable or progressing.  We certainly agree with his perspective, and hold this to be true even in cases of less advanced disease.  The forte of image analyzers is likely their ability to detect change over time. The new Humphrey “Glaucoma Progression Analysis” software is likewise a major advancement for determining  visual field deterioration over time.

  11. “Each instrument appears to have unique strengths and limitations yet they all provide adjunctive information to the current gold standards; standard automated perimetry and stereo disc photography. 

    “Dr. Garway-Heath emphasized that physician judgment remains key in evaluating the output of these imaging devices and in incorporating that into the diagnosis and management of individual patients.

    “ ‘My own feeling is, it’s important that generalists not take the reports of these imaging modalities and view them as gospel,’ he said.  ‘Doctors need to use their intelligence in interpreting these reports, because there is a danger of making decisions without looking at all the evidence.  The imaging reports need to be placed in context of the other clinical information.  It’s then that these instruments will have something to offer beyond photos and visual fields.’

    “Dr. Higginbotham agrees.  She said that glaucoma is a big, gray area and all the data must be considered.”

    Reference
    Scerra, Chet, et al, Several Options Now Available For Imaging Glaucoma. Ophthalmology Times, June 1, 2004 

Lastly, I (RKT) would like to relate a personal experience of how not to compromise your patients quality of life (the ultimate goal, by the way). 

The good man that married my wife and I more than fifteen years ago went to his longstanding family optometrist who had recently acquired a scanning device.  As occasionally happens, the device led the OD to believe this 58-year-old male had glaucoma, i.e., a “false positive” result.  Even though all other diagnostic parameters were within normal limits, this optometrist conferred upon this good man the diagnosis of glaucoma and started him on a topical, pressure-lowering medicine.  This pastor called me long distance that very evening, terrified that he might go blind.  How truly sad.  I had him see an OD friend of mine in his same local area for a second opinion, and he was found to be completely normal via the Gold Standard of a competent, comprehensive eye examination.

This is a prime example of how some patients are being abused through personal incompetence; the technology can be helpful when used by a competent doctor who truly understands how to integrate and interpret the clinical data in the context of a comprehensive assessment.  So, again, by all means, purchase one of these devices and use it with sound clinical judgment.  As said before, our instrument of choice at this time is the GDx-VCC. 


GDx-VCC printout of glaucoma suspect patient referred in for a 2nd opinion. Asymmetric cupping is easily sean. The nerve fiber index (NFI) numbers are 23-OD and 26-OS, well within normal limits. The nerve fiber layer maps at the bottom demonstrate normal "double hump" distributions of NFL thickness. The GDx-VCC and all other clinical findings were compatible. Because of the large ONH cupping, she will be followed annually.


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