Description
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.
- The keratometer (also referred to as an ophthalmometer), the most commonly used instrument, projects an illuminated image onto a central area in the cornea. By measuring the distance between a pair of reflected points in both of the cornea's two (2) principal meridians, the keratometer can estimate the radius of curvature of two (2) meridians. Limitations of this technique include the fact that the keratometer can only estimate the corneal curvature over a small percentage of its surface and that estimates are based on the frequently incorrect assumption that the cornea is spherical.
- The keratoscope reflects a series of concentric circular rings off the anterior corneal surface. Visual inspection of the shape and spacing of the concentric rings provides a qualitative assessment of topography.
- A photokeratoscope is a keratoscope equipped with a camera that can provide a permanent record of the corneal topography.
- Computer-assisted photokeratoscopy is an alternative to keratometry or keratoscopy for measuring corneal curvature. This technique uses sophisticated image analysis programs to provide quantitative corneal topographic data. Early computer-based programs were combined with keratoscopy to create graphic displays and high-resolution, color-coded maps of the corneal surface. Newer technologies measure both curvature and shape, enabling quantitative assessment of corneal depth, elevation, and power.
Regulatory Status
A number of devices have been cleared for marketing by the United States 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.
Table 1. Corneal Topography Devices Clearing by the US Food and Drug Administration
| Device |
Manufacturer |
Date Cleared |
510.k No. |
Indication |
| Populations |
Interventions |
Comparators |
Outcomes |
|
| Individuals: |
Interventions of interest are: |
Comparators of interest are: |
Relevant outcomes include: |
|
- With disorders of corneal topography
|
- Computer-assisted corneal topography/photokeratoscopy
|
- Manual corneal topography measurements
|
- Test accuracy
- Other test performance measures
- Functional outcomes
|
|
| 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 |
Summary of Evidence
For individuals who have disorders of corneal topography who receive computer-assisted corneal topography/photokeratoscopy, the evidence includes only a few studies. Relevant outcomes are test accuracy, other test performance measures, and functional outcomes. With the exception of refractive surgery, a procedure not discussed herein, no studies have shown clinical benefit (e.g., a change in treatment decisions) based on a quantitative evaluation of corneal topography. In addition, a large prospective series found no advantage with use of different computer-assisted corneal topography methods over manual corneal keratometry. Computer-assisted corneal topography lacks evidence from appropriately constructed clinical trials that could confirm whether it improves outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Populations
|
Interventions
|
Comparators
|
Outcomes
|
Individuals:
- With disorders of corneal topography
|
Interventions of interest are:
- Computer-assisted corneal topography/photokeratoscopy
|
Comparators of interest are:
- Manual corneal topography measurements
|
Relevant outcomes include:
- Test accuracy
- Other test performance measures
- Functional outcomes
|
