Detection and Monitoring Diseases of the Cornea
Corneal topography describes measurements of the curvature of the cornea. An evaluation of corneal topography is necessary for the accurate diagnosis and follow-up of certain corneal disorders, such as keratoconus, difficult contact lens fits, and pre- and postoperative assessment of the cornea, most commonly after refractive surgery.
Assessing corneal topography is a part of the standard ophthalmologic examination of some individuals. Corneal topography can be evaluated and determined in multiple ways. Computer-assisted corneal topography has been used for early identification and quantitative documentation of the progression of keratoconic corneas, and evidence is sufficient to indicate that computer-assisted topographic mapping can detect and monitor disease.
Various techniques and instruments are available to measure corneal topography: keratometer, keratoscope, and computer-assisted photokeratoscopy.
Regulatory Status
A number of devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. In 1999, the Orbscan® (manufactured by Orbtek, distributed by Bausch and Lomb) was cleared by the Food and Drug Administration. The second-generation Orbscan II is a hybrid system that uses both projective (slit scanning) and reflective (Placido) methods. The Pentacam® (Oculus) is one of a number of rotating Scheimpflug imaging systems produced in Germany. In 2005, the Pentacam HR was released with a newly designed high-resolution camera and improved optics. Food and Drug Administration product code: MXK.
Device | Manufacturer | Date Cleared | 510.k No. | Indication |
Populations | Interventions | Comparators | Outcomes | |
Individuals: | Interventions of interest are: | Comparators of interest are: | Relevant outcomes include: | |
|
|
|
|
|
VX130 Ophthalmic Diagnostic Device | LUNEAU SAS | 4/24/2017 | K162067 | To scan, map and display the geometry of the anterior segment of the eye |
Pentacam AXL | OCULUS OPTIKGERATE GMBH | 1/20/2016 | K152311 | To scan, map and display the geometry of the anterior segment of the eye |
ARGOS | SANTEC CORPORATION | 10/2/2015 | K150754 | To scan, map and display the geometry of the anterior segment of the eye |
ALLEGRO OCULYZER | WAVELIGHT AG | 7/20/2007 | K071183 | To scan, map and display the geometry of the anterior segment of the eye |
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | HEIDELBERG ENGINEERING | 1/13/2006 | K052935 | To scan, map and display the geometry of the anterior segment of the eye |
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | SIS LTD. SURGICAL INSTRUMENT SYSTEMS | 9/28/2005 | K051940 | To scan, map and display the geometry of the anterior segment of the eye |
PATHFINDER | MASSIE RESEARCH LABORATORIES INC. | 9/2/2004 | K031788 | To scan, map and display the geometry of the anterior segment of the eye |
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) | BAUSCH & LOMB | 7/23/2004 | K040913 | To scan, map and display the geometry of the anterior segment of the eye |
PENTACAM SCHEIMPFLUG CAMERA | OCULUS OPTIKGERATE GMBH | 9/16/2003 | K030719 | To scan, map and display the geometry of the anterior segment of the eye |
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM | NIDEK INC. | 8/6/1999 | K991284 | To scan, map and display the geometry of the anterior segment of the eye |
ORBSCAN | TECHNOLAS PERFECT VISION GMBH | 3/5/1999 | K984443 | To scan, map and display the geometry of the anterior segment of the eye |
VX130 Ophthalmic Diagnostic Device | LUNEAU SAS | 4/24/2017 | K162067 | To scan, map and display the geometry of the anterior segment of the eye |
Non-computer-assisted corneal topography is considered part of the evaluation and management services of general ophthalmologic services (CPT codes 92002-92014), and therefore this service should not be billed separately. There is no separate CPT code for this type of corneal topography.
Computer-assisted corneal topography is considered not medically necessary to detect or monitor diseases of the cornea
92002 | 92004 | 92012 | 92014 | 92025 |
H16.001 | H16.002 | H16.003 | H16.009 | H16.011 | H16.012 | H16.013 |
H16.019 | H16.021 | H16.022 | H16.023 | H16.029 | H16.031 | H16.032 |
H16.033 | H16.039 | H16.001 | H16.041 | H16.042 | H16.043 | H16.049 |
H16.051 | H16.052 | H16.053 | H16.059 | H16.061 | H16.062 | H16.063 |
H16.069 | H16.071 | H16.072 | H16.073 | H16.079 | H16.101 | H16.102 |
H16.103 | H16.109 | H16.001 | H16.111 | H16.112 | H16.113 | H16.119 |
H16.121 | H16.122 | H16.123 | H16.129 | H16.131 | H16.132 | H16.133 |
H16.139 | H16.141 | H16.142 | H16.143 | H16.149 | H16.201 | H16.202 |
H16.203 | H16.209 | H16.211 | H16.212 | H16.213 | H16.219 | H16.221 |
H16.222 | H16.223 | H16.229 | H16.231 | H16.232 | H16.233 | H16.239 |
H16.241 | H16.242 | H16.243 | H16.249 | H16.251 | H16.252 | H16.253 |
H16.259 | H16.261 | H16.262 | H16.263 | H16.269 | H16.291 | H16.292 |
H16.293 | H16.299 | H16.301 | H16.302 | H16.303 | H16.309 | H16.311 |
H16.312 | H16.313 | H16.319 | H16.321 | H16.322 | H16.323 | H16.329 |
H16.331 | H16.332 | H16.333 | H16.339 | H16.391 | H16.392 | H16.393 |
H16.399 | H16.401 | H16.402 | H16.403 | H16.409 | H16.411 | H16.412 |
H16.413 | H16.419 | H16.421 | H16.422 | H16.423 | H16.429 | H16.431 |
H16.432 | H16.433 | H16.439 | H16.441 | H16.442 | H16.443 | H16.449 |
H16.8 | H16.9 | H17.00 | H17.01 | H17.02 | H17.03 | H17.10 |
H17.11 | H17.12 | H17.811 | H17.812 | H17.813 | H17.819 | H17.821 |
H17.822 | H17.823 | H17.829 | H17.89 | H17.9 | H18.001 | H18.002 |
H18.003 | H18.009 | H18.011 | H18.012 | H18.013 | H18.019 | H18.021 |
H18.022 | H18.023 | H18.029 | H18.031 | H18.032 | H18.039 | H18.041 |
H18.042 | H18.043 | H18.049 | H18.051 | H18.052 | H18.053 | H18.059 |
H18.061 | H18.062 | H18.063 | H18.069 | H18.10 | H18.11 | H18.12 |
H18.13 | H18.20 | H18.211 | H18.212 | H18.213 | H18.219 | H18..221 |
H18.222 | H18.223 | H18.229 | H18.231 | H18.232 | H18.233 | H18.239 |
H18.30 | H18.311 | H18.312 | H18.313 | H18.319 | H18.321 | H18.322 |
H18.323 | H18.329 | H18.331 | H18.332 | H18.333 | H18.339 | H18.40 |
H18.411 | H18.412 | H18.413 | H18.419 | H18.421 | H18.422 | H18.423 |
H18.429 | H18.43 | H18.441 | H18.442 | H18.443 | H18.449 | H18.451 |
H18.452 | H18.453 | H18.459 | H18.461 | H18.462 | H18.463 | H18.469 |
H18.49 | H18.50 | H18.51 | H18.52 | H18.53 | H18.54 | H18.55 |
H18.59 | H18.601 | H18.302 | H18.603 | H18.609 | H18.611 | H18.612 |
H18.613 | H18.619 | H18.621 | H18.622 | H18.623 | H18.629 | H18.70 |
H18.711 | H18.712 | H18.713 | H18.719 | H18.721 | H18.722 | H18.723 |
H18.729 | H18.731 | H18.732 | H18.733 | H18.739 | H18.791 | H18.792 |
H18.793 | H18.799 | H18.811 | H18.812 | H18.813 | H18.819 | H18.821 |
H18.822 | H18.823 | H18.829 | H18.831 | H18.832 | H18.833 | H18.839 |
H18.891 | H18.892 | H18.893 | H18.899 | H18.9 |
Practice Guidelines and Position Statements
A 1999 American Academy of Ophthalmology (AAO) assessment indicated that computer-assisted corneal topography evolved from the need to measure corneal curvature and topography more comprehensively and accurately than keratometry and that corneal topography is used primarily for refractive surgery. AAO indicated several other potential uses: (1) to evaluate and manage individuals following penetrating keratoplasty, (2) to plan astigmatic surgery, (3) to evaluate individuals with unexplained visual loss and document visual complications, and (4) to fit contact lenses. However, the AAO assessment noted the lack of data supporting the use of objective measurements (as opposed to subjective determinants, like subjective refraction) of astigmatism.