New Motor-driven Adjustable IOL Design

A significant problem for both patients and the cataract surgeon today is the difference between the desired and the actual post-operative refraction achieved after cataract surgery. The new IOL design will allow the first generation of these lenses to have their axial position in the eye adjusted multiple times without requiring further surgery. This will adjust the effective insitu refraction. Later generations will allow astigmatic errors to be corrected as well as providing very effective accommodative IOLs Dennis Murphy 28 Jan 2011

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New Motor-driven Adjustable IOL Design
The causes of refractive errors
There are many variables that determine the final refractive outcome for any patient. Some important parameters include the preoperative biometry measurements of the anterior cornea surface curvature and the axial length of the eye. These measurements are then used in a regression equation to estimate the IOL power required to produce emmetropia in that eye. The anterior cornea measurements rely on Keratometry to measure the curvature of the front surface of the cornea. This measurement however is only part of the optical path through the entire eye. The path must also include the posterior curvature of the cornea as well as the cornea thickness and its refractive index. The Keratometer gives an estimate of the total corneal power based on the anterior surface curvature it measured and a posterior radius that is estimated as a percentage of the anterior radius according to a “standard cornea” model. It also uses a standardized corneal thickness as well as an assumed refractive index. Problems can arise due to the fact that the dimensions of each cornea are not exactly same the same as the “standard cornea”. In addition, if the patient has undergone any previous corneal refractive surgery such as radial keratotomy, photorefractive keratectomy, LASEK or LASIK procedures then these operations can change the assumed relationship between the anterior and posterior corneal surface curvatures. The end result is that the estimated total corneal power may be a little different to the real power. The other major measurement needed is the axial length of the eye from the front of the cornea to the retina. This is usually done using A-scan biometry. This technique uses ultrasound and the measurement is based on knowing how long the sound wave takes to travel from one point to the next in various tissues. As the sound pulse travels through the eye, a certain amount of energy from the wave is reflected back to the probe at each interface in the eye (e.g. cornea/aqueous/lens/vitreous/retina). The various spikes returned to the probe are then used to calculate the distances through the cornea, the anterior chamber, the lens and the vitreous body. There are many structures (including the cataract itself) within the eye that reflect the ultrasound energy. To get an accurate axial depth measurement the operator has to know which of the many returned echo spikes represent the required points along the optic path. These spikes are then tagged and the instrument applies the appropriate sound velocities between each of the spikes of interest in order to accurately measure the cornea thickness, the anterior chamber depth, the lens thickness and the vitreous chamber depth. In addition, the ultrasound probe must be held exactly parallel to the optical axis of the eye, otherwise the ultrasound path through the eye will not follow the actual path whose measurement is required. Also if the probe is pressed too hard against the cornea it will cause the cornea to deflect inwards and hence shorten the measured path. The end result of any errors in identifying the correct return echo spikes, or any alignment or probe application force errors, will mean that the measured total axial eye length will be different to the actual length. There are various formulas used to calculate the required IOL power. Which one is used depends on whether the patient’s eye length is close to the average length, or is shorter or

3 longer. The actual calculation is generally done internally in the instrument based on the data fed to it by the surgeon. While the actual forms of the various equations within the instrument are complex, the general form for an average axial length eye (approx. 22mm to 24.5mm) is shown below P = A – 2.5L – 0.9K Where: P = IOL power in diopters required to produce emmetropia A = the “A” position constant supplied by the manufacturer L = axial length of eye (mm) K = estimated total corneal power (diopters) from the keratometry measurements All of the equations used to predict what IOL power is required to produce emmetropia in the patient’s eye are examples of multiple regression analysis where we have several independent input parameters (A, L & K). The object of regression analysis is to predict the “average” value of the dependent output variable – which in this case is the required IOL power. Several problems can arise from using a regression formula to predict the required IOL power as opposed to doing an impractical (but much more accurate) ray-trace through the eye. The first of these are the uncertainties in the measurement of both the true axial length of the eye and the actual total corneal power as discussed at the start of this article. Second, is the assumption in the various equations that the dimensions of the anterior and posterior segments in the eye are always proportional to each other as per the standard model eye. This is almost never exactly true and in some cases can be significantly different to the “standard model” The third potential problem arises because of uncertainty in exactly where the implanted lens will actually sit in the capsular bag in the eye. The axial position of the implanted lens has a major effect on the effective insitu power of the IOL. Any unexpected changes in this position can lead to large refractive errors. There are two issues here. The A-constant that is supplied by the manufacturer for each of their IOL models is only an estimate of where they believe their particular IOL will sit within the capsular bag after implantation. As can be seen in FIG. 1, the axial position of the optic body of the IOL will be influenced by a number of factors such as the haptic angulation – the maximum diameter of the capsular bag (e.g. larger haptic angles with a smaller capsule diameter will push the lens closer to the retina) – and the actual axial position of the maximum diameter of the capsular bag along the optic axis of the eye. To some extent the actual position of the implanted lens will also depend on each surgeon’s operating technique. Depending on the actual circumstances of each eye and operation, the axial position of the lens may vary from what the surgeon expects.

4 A further difficulty lies in the allowable power tolerance range allowed on IOLs. This is shown in the table below. Many ophthalmologists seem to be unaware of just how large the power tolerance range of IOLs is. As the table shows, the tolerance becomes larger as the dioptric power increases. This large tolerance band is a significant part of the problem in the “refractive surprises” that occur after some cataract operations. This is because refractive errors are much more likely to occur with higher dioptric power IOLs as axial position accuracy is more important at higher powers. The fact that the power tolerances are much larger on higher powered IOLs just compounds the problem.

Power range tolerances as per ISO 11979-2 – Table one
Table 1 – Tolerances on dioptric power Nominal dioptric power range Tolerance on dioptric power D D 0 to =< 15 Plus or Minus 0.30 > 15 to =< 25 Plus or Minus 0.40 > 25 to =< 30 Plus or Minus 0.50 > 30 Plus or Minus 1.0 The ranges apply to positive as well as negative dioptric powers

Commonly applied solutions
Faced with a patient with a significant postoperative refractive error, the most common methods used to fix the situation are    Corneal refractive surgery using a LASIK type procedure is performed to correct the surprise if the error is within about plus or minus 2 diopters. Piggyback IOLs can be fitted in some cases where there is a large error and where corneal surgery is not appropriate. An IOL exchange can be done fitting a supposedly more accurate lens to correct the refractive error. However many ophthalmologists see this as a last resort as the replacement refractive error and complication rate can be higher than other corrective procedures

Two newer types of adjustable IOLs are also being implanted to counter the possibility of refractive errors.  The light adjustable IOL. Using this device the surgeon gets the chance after the surgery to correct the dioptric power of the IOL by using a non-invasive UV light source to adjust the light sensitive polymer of the lens and change its dioptric power. Astigmatic errors in the cornea can also be compensated for. However, once the lens is “locked” in its final geometric configuration it cannot be changed again. The mechanically adjustable lens. This provides a variable-focus and is able to be repeatedly and reversibly adjusted in its axial position in the eye to correct any refractive error. There are a couple of types of lenses in this category. The all plastic type which needs surgery to adjust the haptic position relative to the central lens and the magnetic type which uses an external magnetic field to adjust the axial position of the lens without

5 the need for surgery. The disadvantage of the magnetic type is that they cannot safely be exposed to high magnetic fields such as used in an MRI scanner.

The New Motor-driven Adjustable IOL
A new lens design is now under development that will allow the axial position of the lens in the eye to be adjusted as many times as needed – without the need for surgery (see FIG, 2). This will allow any residual postoperative refractive "surprises" to become a thing of the past. The axial movement of the lens relative to the fixed haptic position in the capsular bag is carried out by a very small ultrasonic motor that is only 1 mm dia. by 0.20 mm thick (see FIG.3) This motor is an integral part of the lens assembly and has no metallic or magnetic materials in it. This means that the patient can safely undergo diagnostic imaging procedures in an MRI scanner without any problems from the very strong magnetic fields associated with an MRI scan. Also because there are no metallic components in the lens construction, the lens assembly has neutral buoyancy in the aqueous humor in the posterior chamber of the eye and therefore has no tendency to tip under the influence of gravity. The new lens assembly is made in such a way that the “sharp” (square) posterior edge of the lens assembly is always held against the posterior capsule surface in order to minimize any postoperative capsular opacification (PCO.) The rotation direction and speed of the motor is powered and controlled by a unit that is external to the eye. The motor is self-locking so that after adjustment the lens will not move accidently. The ultrasonic power level is less than the intensity allowed by the FDA for safe use in the eye. The motor is an example of what is commonly referred to as a micro-electro-mechanicalsystem (MEMS). In the most general sense, MEMS is a technology that is defined as an assembly of miniature mechanical or electro-mechanical elements. The devices are manufactured using the techniques of micro-fabrication. The physical dimensions of assembled MEMS devices can range from about 20 microns up to a millimeter or so. Individual MEMS components generally range in size from about 1 micron to 200-300 microns (e.g. 0.001 mm to about 0.30 mm) Common examples of high volume usage MEMS devices in everyday use include the accelerometers that are used in airbag control systems in cars and the inkjet print-head technology used in printers for computers.

6 The single lens version of the new IOL has an axial adjustment range of 0.70 mm. Using raytracing methods this gives an effective insitu power adjustment of plus and minus 0.86D on a 30 diopter lens as it is moved along the axis from its central position. The adjustment range drops to plus and minus 0.64D on a 20 diopter lens (see FIG. 4) A greater dioptric power adjustment range can be obtained by the use of a dual lens design IOL.

The Future for MEMS based IOLs
The next generation of the new IOL will have an additional set of much smaller MEMS motors that are used to change the toricity of the lens to null out any astigmatic geometry variations in the cornea that may progressively occur as the patient ages. The concept of using active manipulation of the lens by way of inbuilt MEMS technology is much closer to how the eye actually works than the traditional passive IOLs which are in current use. By using other versions of MEMS motors with built-in energy harvesting systems and associated sub-miniature electronic control circuitry we will be able to produce IOLs that can accommodate (focus) like the natural lens. IOL design is now slowly but surely changing to make the next generation of lenses more like the natural lens though the use of inbuilt MEMS technology. This will require companies to employ engineers on their design staff who have the necessary experience and background to design both the optical elements of the new IOLs as well as the drive and control mechanisms needed for these new types of lenses.

Some more to explore
The MEMS Handbook Second Edition – Edited by M. Gad-el-Hak Mechanism of human accommodation as analyzed by nonlinear finite element analysis – by Ronald A. Schachar and Andrew J. Bax , Annals of Ophthalmology, Humana Press Inc. Textbook of Ophthalmology, Volume 2 – By Sunita Agarwal, Athiya Agarwal, David J Apple +++++++++++++++++++++++++++++++++++++++++++++

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