Industry Trends Optical coherence tomography (OCT) is a technique that allows physicians to acquire images of translucent or opaque material (such as biological tissue) at resolutions similar to low-power microscopes. The devices that make use of this technology to perform retinal imaging have become an integral part of tracking the progress of treatment and pathology
Industry Trends Currently in the U.S. opthalmic device market, competition is limited from manufacturers that are either new or trying to expand into the U.S. market. Many ophthalmic device manufacturers have recently entered the market. Some of these companies are based in Italy, Japan and China, and severely undercut the prices in order to gain market
The full report suite on the U.S. market for interventional ophthalmic devices includes disease rates, ophthalmic lasers, intraocular lenses (IOLs), phacoemulsification consoles, ophthalmic viscosurgical devices (OVDs) and glaucoma shunts. Currently the U.S. market for interventional ophthalmic devices is being limited by high prices. High prices for the capital equipment in this market are passed on to the consumer as much of the interventional market is based upon elective surgeries. While many are willing to pay for premiums to undergo corrective surgery others will seek out alternative solutions or decide to live with their vision issues.
Corneal topography is also known as videokeratography or corneal mapping. Characterizing the curvature of the cornea is important because this tissue contributes significantly to the refractive power of the eye. Corneal topography is used for evaluating the curvature of the cornea. This information is then used for contact lens fitting and for planning refractive procedures such as Laser Assisted In-Situ Keratomileusis (LASIK) or Phakic intraocular lens implantation. Corneal topography is also used for detecting keratoconus, which is characterized by thinning of the cornea to a point where the intraocular pressure is sufficient to cause the cornea to assume a cone shape. The devices also have an application in planning cataract surgery. Toric intraocular lens (IOL) implantation is effective in treating regular astigmatism. However, to the extent that the patients astigmatism is irregular, with the principle meridians of the eye not lying perpendicular to one another, toric IOLs will be ineffective. Corneal topography can provide a definitive assessment of the nature of a patients corneal astigmatism. As such, corneal topography is an essential preoperative step for the implantation of a toric IOL. Because of the increasing popularity of advanced technology IOLs in cataract surgery, and the associated importance of corneal analysis in the pre-operative process, manufacturers have been releasing products in recent years that specifically target applications associated with cataract surgery. This includes devices that combine corneal topography with optical biometry, pachymetry and other corneal measurements.
Fundus cameras, which are also known as retinal cameras, are low powered microscopes coupled with a camera. The fundus encompasses structures in the back of the eye, including the retina, optic disc, macula and posterior pole. Fundus cameras are used for diagnosing and tracking the progression of ocular diseases affecting the fundus, such as macular degeneration and glaucoma.
Several types of IOLs are used for cataract surgery. The most common is the monofocal IOL, which allows for focus at a fixed distance. A disadvantage of the monofocal IOL is the requirement of the patient to wear corrective lenses after cataract surgery. Monofocal lenses include both spheric and aspheric IOLs. The difference between the two is in the surface of the lens, whether it is spherical or aspherical. This curvature is related to the correction of spherical aberration, or the excessive refractive power of the cornea at its periphery. Aspheric lenses are generally considered to be superior. They have been shown to produce clearer vision and greater contrast sensitivity. In the Nordic region 90% of the market is aspheric. Southern Europe uses more spherical lenses while Germany uses more aspheric. However, the use of aspheric IOLs involves a trade-off, with conventional (spheric) IOLs having been shown to produce better depth of focus and near vision.
Optical biometers are partial coherence interferometry devices designed to generate a range of biometry measurements as well as to assist with intraocular lens (IOL) calculations. Optical biometers are capable of taking multiple measurements including axial length, anterior chamber depth, corneal thickness and lens thickness. All measurements are taken at a single optometry or ophthalmology station. Contact with the cornea is not required for the functioning of optical biometers, which improves measurement accuracy.
LASERs, which stands for Light Amplification (by) Stimulated Emission (of) Radiation, were developed in 1960 by Theodore Maiman. Lasers were quickly adopted for ophthalmology with the first instance of their clinical use appearing in 1963. Over the last 50 years ophthalmic lasers have proliferated in both types of lasers and indications. Despite this diversity, all lasers function on the same fundamental principles. Lasers are created when the electrons in atoms in special glasses, crystal or gases absorb energy from an electrical current or another laser and become excited/elevated to a higher energy state. Electron orbits are less stable at these higher energy states, thus energy is released in the form of a photon which allows the electron to return to its ground state. Photons are particles of light, however, what makes laser photons unique is that they are all of the same wavelength, directional, and coherent (meaning the crests and troughs of the light waves are aligned) whereas ordinary light comprises multiple wavelengths and is not coherent.
Ophthalmic ultrasound is a non-invasive technique to image ocular structures. Because ophthalmic ultrasound uses high-frequency sound waves, it has advantages over light microscopy, including the ability to detect anomalies that cannot be identified by visual examination such as those affecting opaque tissues and regions within the eye. The applications for ophthalmic ultrasonography include the detection of glaucoma, infections, eye trauma and for calculating the power of the intraocular lens (IOL) required in cataract surgery. Ultrasonography is also used for aiding physicians with the placement of instruments during surgery.
Ophthalmic viscosurgical devices (OVD) are viscoelastic solutions used in several eye surgeries. They are also referred to as viscoelastic agents. These fluids have had a great influence on both extracapsular and phacoemulsification surgeries and their use has decreased the incidence of corneal edema. The main task of the OVD is protecting the inner side of the cornea during surgery. It accomplishes this by maintaining a deep anterior chamber during anterior segment surgery. This space prevents contact with and possible damage to the endothelial cell layer on the inner side of the cornea and the surrounding ocular tissues. In addition OVDs help to push back the vitreous face in the event of a posterior capsule tear or a rent in the zonules all the while preventing formation of a flat chamber during surgery.
Refractive errors can be corrected by procedures such as Phakic IOL implantation and Laser Assisted In-Situ Keratomileusis (LASIK). LASIK modifies corneal thickness; thus it is limited by the amount of corneal tissue that can be safely removed. If too much is removed, the cornea becomes too thin and weak, and bulging of the cornea could occur, which is a condition known as ectasia. Treatment of ectasia involves exchanging the cornea in a procedure called keratoplasty, which leaves the patient with very poor vision. Phakic IOL implantation has the advantage of being able to correct a higher degree of refractive error than LASIK. Even with these disadvantages, LASIK is the leading refractive surgery procedure because phakic IOL implantation is more expensive, and implantation of these lenses is a more invasive procedure.
Slit lamps are binocular microscopes that are coupled with illumination systems. Slit lamps are used for diagnosing a wide variety of eye conditions including cataracts, corneal injuries, retinal detachment, macular degeneration, dry eye syndrome, retinitis pigmentosa and uveitis. Basic slit lamps are used for observing anterior eye segment structures including the eyelid, cornea, lens and iris. The addition of special lenses to the slit lamps provides for the ability to view intraocular and posterior regions of the eye. Other accessories for slit lamps include ocular and objective lenses, contact tonometers, background illuminators, beam splitters and digital imaging equipment.
A tonometer is a device that is used for measuring the intraocular pressure of an eye. Elevated intraocular pressure is associated with glaucoma, a disease that is characterized by the degeneration of the optic nerve. Tonometers are segmented into contact or non-contact types. The market for contact tonometers consists of both Goldmann tonometers and portable electronic, or hand held, tonometers. Portable electronic tonometers have been on the market for approximately 25 years. However, these devices have recently had success in new areas. In particular, optometrists have been adopting handheld devices in recent years. Goldmann and handheld contact tonometers are not direct competitors. Most ophthalmologists have a Goldmann but many are also interesting in having a handheld device on hand as a secondary tonometer.
Wavefront aberrometry is used for measuring the total refractive power of the eye. A wavefront represents the quality of light passing through the eye. Factors that affect a wavefront are optical elements such as lenses or the cornea of the eye. Aberrometry provides detailed information about the visual performance and refractive power of the eye. Wavefront aberrometers can detect errors including myopia, hyperopia and astigmatism. Aberrometry is especially useful for higher-order refractive errors and lenticular changes that cannot ordinarily be detected by routine ophthalmic exams. These include spherical and coma aberrations, which cause halos or comet-like streaks around light foci.
In 2016, more integration was seen in the overall market for diagnostic and interventional ophthalmic devices. In the diagnostic space, practitioners are enjoying better, more flexible diagnostic capabilities with ophthalmic data management systems; these systems unify discrete pieces of diagnostic equipment. A similar technology, procedure planning software, unifies different surgical equipment for more precise and reliable cataract surgery. This software is bringing the diagnostic and interventional sides of the market closer together, with diagnostic information being imported for use during the surgical process. Integration is also changing the competitive landscape. Topcon and Carl Zeiss Meditec, players traditionally focused on diagnostics, are now gaining footholds in the market for surgical products.