Autorefractors (ARs), also called automated refractors, are computer-controlled routine diagnostic devices used for detecting refractive errors of the eye. They are useful in the determination of a patient’s prescription for contact lenses or eye glasses. During the examination process, the patient uses one eye at a time to look into the machine at an image, which is projected onto the retina. The autorefractor adjusts the path of the light until the image that it observes on the patient’s retina is in focus. The degree of correction necessary to achieve this is the basis for the patient’s refractive prescription. This is an entirely automated process which does not require feedback from the patient. Cycloplegic agents are necessary to dilate the pupil, thereby eliminating a diagnostic error caused by pseudomyopia, a result of a constriction of the ciliary muscles.

Binocular indirect ophthalmoscopes (BIOs) are used by all optometrists and ophthalmologists and are needed in every practice, as well as in every lane of a practice. In 2016, there were approximately 40,000 optometrists and 18,000 practicing ophthalmologists in the United States. Typically, the average optometrist has 1.5 lanes in their practice and the average ophthalmologist has 3.5 lanes.

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 patient’s 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 patient’s 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.

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.

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

Optometrists and ophthalmologists work in an environment where multiple pieces of equipment are routinely used for the diagnosis and treatment of a single patient. For example, to test for the presence of glaucoma, a patient may be assessed with optical coherence tomography (OCT), fundus imagery, perimetry, and some form of tonometer for measurements of intraocular pressure (IOP). Ophthalmic data management systems are diagnostic information and patient profile solutions that allow the practitioner to store, access, and review information in an efficient and clinically meaningful way. The systems allow practitioners to display and compare reports from a single diagnostic tool over an extended period of the patient’s history. For example, fundus imagery of a diabetic retinopathy patient can be compared from the beginning of the onset of the pathology throughout the period of treatment. Alternatively, reports from multiple devices can be reviewed at once to facilitate a highly informed diagnosis. All of these functions can be performed from the practitioners office or using a wireless device.

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.

Some ophthalmic conditions can lead to tunnel vision, a disorder characterized by loss of vision. Glaucoma, a disease of the optic nerve, can ultimately result in visual field loss. Other diseases can alter the visual field, including those that affect other eye structures such as the retina and those that impact neurological function. To diagnose and measure the progression of diseases that affect visual field, patients are subjected to visual field tests. A perimeter is a device that is used for measuring a patient’s visual field.

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 Goldmannn 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. Goldmannn and handheld contact tonometers are not direct competitors. Most ophthalmologists have a Goldmannn 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.

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 ophthalmic devices includes disease rates, ophthalmic coherence tomography, fundus cameras, data management systems, slit lamps, perimeters, tonometers, autorefractors/keratometers, binocular indirect ophthalmoscopes, ophthalmic ultrasound devices, wavefront abberometers, corneal topographers, and optical biometers. Currently the U.S. market for ophthalmic devices is being limited by competition 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 share. The lower pricing and reduction in market share results in an overall adjustment in the ASPs. This is evident in the ophthalmic ultrasound and fundus camera markets, where Chinese and Italian manufacturers are entering the market with lower cost options.

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 patient’s 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 patient’s 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.