Soft Material Selection/Fitting and Evaluation



Soft Material Selection/Fitting and Evaluation


Vinita Allee Henry

Julie Ott DeKinder



Soft contact lenses were introduced in the 1970s. The soft lenses were essentially hydrogel lenses, which were dependent on the water content of the lens to provide oxygen to the cornea. In the late 1990s and early 2000s, a revolutionary new soft lens material, silicone hydrogel, was introduced. This new material incorporated the high oxygen permeability (Dk) of silicone with the benefits of conventional hydrogel lenses.1 Both types of soft contact lens materials are flexible and made of a plastic that is able to absorb or bind water. Although many similarities exist between hydrogel and silicone hydrogel materials, there are distinct differences between their material properties. When placed on the eye, both forms will conform to the shape of the cornea. Soft lenses have excellent memory; therefore, the lenses can be folded with the edges touching and, when released, will return to the normal shape. The lenses may be inverted and returned to right side out without damaging the optics. Increased water content in the lens, surface treatments, wetting agents, or hydrophilic monomers are used to make this lens surface wettable. This increased wettability also increases the adherence of environmental contaminants (i.e., bacteria, tear lipids and proteins, dust) when the lens is placed in contact with these substances. The purpose of this chapter is to discuss soft lens materials, their similarities and differences, and their properties.


▪ MATERIAL PROPERTIES

Hydrogel contact lens materials are made with a stable, solid polymer component that can absorb or bind with water. Spaces exist in the crossed-linked polymer and are called pores. These pores allow fluid (water) to enter the lens material, thus making it hydrated and soft.

The polymers consist of small building blocks called monomers. Therefore, a sequence of repeating units is created. When more than one monomer is used, the term copolymer is more appropriate. Most soft contact lens materials are copolymers. A chemical is added to the monomers to create polymerization. Thus, the backbone of the lens has a series of repeating units that can be arranged, either in a random or nonrandom manner, depending on how the polymerization was initiated.2 These repeating units are then cross-linked to each other. By varying the amount of cross-linking agents, the copolymer will vary in its ability to absorb fluid, in this case, water.

By polymerizing different combinations of monomers, the physical and chemical properties of the lens material can be created, such as water content, refractive index, hardness, mechanical strength, and oxygen permeability. The following monomers are those that are most commonly used to create hydrogel contact lenses3:



  • 2-Hydroxyethyl methacrylate (HEMA) is the monomer that was used to create the first commercial hydrogel contact lens, and it continues to be the monomer most often utilized. By itself, it will allow a water content of about 38%. When it is combined with other monomers (such as N-vinyl pyrollidone or methacrylic acid), the water content can be increased to 55%
    to 70%.2 HEMA is an extremely stable material, and variations in temperature, pH, or tonicity have relatively little effect on its water content. It also offers good wettability.


  • Ethylene glycol dimethacrylate (EGDMA) is used primarily as a cross-linking agent. Its primary function is to increase the dimensional stability of the material.3 Increased use of EGDMA will tend to make the material stiffer, lower in water content, and less stretchable.


  • Methacrylic acid (MAA) is used to increase the water content of the lens material. It is extremely hydrophilic because of the presence of a free carboxylic acid group that bonds water. It therefore also tends to impart ionic (charged) properties to a material.


  • Methyl methacrylate (MMA) is sometimes used to lower water content or to increase the material hardness or strength of a material. It offers excellent optical clarity and is completely inert and very stable, but does not offer any permeability to oxygen.


  • N-vinyl pyrrolidone (NVP) is very hydrophilic and is used to increase water content; it offers excellent wettability, and its high water uptake allows for increased oxygen permeability. It generally imparts an ionic property to the material.


  • Glyceryl methacrylate (GMA) offers good wettability and helps to increase deposit resistance because it creates smaller pore sizes.4 Because it also lowers the water content of the material, it imparts a lower Dk.


  • Polyvinyl alcohol (PVA) is very hydrophilic, thereby increasing the water content and the Dk of the lens material. It is highly biocompatible and extremely resistant to deposits. It also imparts increased hardness and strength, along with excellent optical clarity. It is completely inert and very stable.

The characteristics of these polymers are summarized in Table 10.1.5

Silicone hydrogel lenses were the result of years of research to find a way to combine silicone with conventional hydrogel monomers. Before the introduction of silicone hydrogels, lenses made of silicone elastomers had exceptional oxygen transmission, yet demonstrated poor
wettability, poor comfort, manufacturing difficulties, corneal adherence, and were prone to deposits.1 Silicone has the ability to link carbon, hydrogen, and oxygen. Silicone-based polymers are composed of long chains of polymers. It is this make-up of long chains and small relative diameter that gives these polymers their elasticity and strength.6 The properties of silicone have already been observed in gas-permeable (GP) lenses, where silicone was added to increase oxygen transmission in high-Dk GP lens materials. Discovering the method of combining hydrogel properties with silicone allowed for the manufacture of a high-Dk, comfortable, wettable lens with optical clarity and deposit resistance.








TABLE 10.1 COMMON MATERIAL MONOMERS AND THEIR CHARACTERISTICS











































MONOMER


ABBREVIATION


ADVANTAGES


DISADVANTAGES


Hydroxyethyl methacrylate


HEMA




  • Hydrophilic



  • Flexible



  • Softness



  • Good wettability




  • Low oxygen permeability


Ethylene glycol dimethacrylate


EGDMA




  • Stability




  • Low oxygen permeability


Methacrylic acid


MAA




  • Hydrophilic




  • pH sensitive


Methyl methacrylate


MMA




  • Hardness



  • Machinable



  • Optical clarity



  • Stability; inert




  • No oxygen permeability


N-vinyl pyrrolidone


NVP




  • Hydrophilic



  • Good wettability



  • High water uptake



  • High oxygen permeability




  • pH sensitive


Glyceryl methacrylate


GMA




  • Good wettability



  • Good deposit resistance




  • Low oxygen permeability


Polyvinyl alcohol


PVA




  • Hydrophilic



  • High water uptake



  • Deposit resistance




  • May be more difficult to manufacture


Whether a hydrogel or silicone hydrogel material, ideally, material properties are chosen to create a contact lens material that has the following characteristics:



  • Safe


  • Inert


  • Nontoxic


  • Biocompatible


  • Chemically and physically stable


  • Good wettability


  • Deposit resistant


  • Durable


  • Easy to formulate and manufacture


  • Good optical clarity

In reality, tradeoffs between some of these characteristics must be made. The final lens material can then be evaluated in terms of the following properties:


Transparency

Transparency refers to the clearness (clarity) of a material. Among other factors, it is a function of the chemistry, purity, and hydration of the material. No material is completely transparent, as some light will always be reflected, absorbed, and scattered. Transparency is often expressed as a percentage of incident light of a certain wavelength that passes through a sample of the material. Values for most clear (nontinted) contact lens materials range from 92% to 98%.


Hardness and Stiffness

The hardness of a lens material is an important quality affecting its ability to be used for the manufacture of contact lenses and its durability. Generally, hardness is an attribute that is more relevant to rigid lens materials than soft materials. Stiffness is the degree of flexibility of a material, and this can be an important factor when a lens material is selected for a patient. More flexible materials usually result in better initial comfort but do not mask or correct corneal astigmatism, as they tend to drape over the cornea and conform to its shape. Stiffer materials retain their shape during handling and will make insertion and removal of the lens easier.


Tensile Strength

The tensile strength of a material is a value that expresses how much stretching force can be applied before it breaks. Materials with a high tensile strength tend to be more durable, as they are better able to withstand the forces applied during lens handling procedures (i.e., cleaning, inserting) without tearing.


Modulus of Elasticity

The modulus of elasticity is a constant value that expresses a material’s ability to keep its shape when subjected to stress and to resist deformation. Materials with a high modulus are stiffer, resist deformation, hold their shape better, are easier to handle, and may provide better visual acuity.
Many silicone hydrogel materials have a lens modulus much greater than hydrogel materials. The stiffer lens may have the benefits mentioned previously, or it may adversely affect the lens performance by causing edge lift or fluting, superior epithelial arcuate lesions (SEALs), mucin balls, or giant papillary conjunctivitis [GPC, also called contact lens papillary conjunctivitis (CLPC)].7,8,9 Materials with a low modulus of elasticity are less resistant to stress. Most hydrogel materials fall in the low-modulus category. Modulus values can be found in Table 10.2.1,7,9,10








TABLE 10.2 LENS MODULUS VALUES











































MATERIAL NAME


HYDROGEL OR SILICONE HYDROGEL


MODULUS (MPA)


pHEMA


Hydrogel


0.50


lotrafilcon A (Focus N & D)


Silicone hydrogel


1.4-1.52


balafilcon A (PureVision)


Silicone hydrogel


1.1-1.25


lotrafilcon B (O2Optix)


Silicone hydrogel


1.0-1.2


asmofilcon A (PremiO)


Silicone hydrogel


0.90


comfilcon A (Biofinity)


Silicone hydrogel


0.75-0.8


senofilcon A (AV Oasys)


Silicone hydrogel


0.6-0.72


enfilcon A (Avaira)


Silicone hydrogel


0.5


galyfilcon A (AV Advance)


Silicone hydrogel


0.4-0.43



Refractive Index

Refractive index of a lens material is the ratio of the speed of light in air to the speed of light in the material. Materials with higher refractive indices cause more refraction of incident light. For soft lens materials, the index of refraction is related to water content. Generally, increasing the water content lowers the refractive index. A hydrogel lens material with a water content of 80% has a refractive index of about 1.37, and one with a water content of 42% has a refractive index of about 1.44, compared to silicone hydrogel materials (lotrafilcon A and balafilcon A), which have a refractive index of 1.43.11,12


Wettability

The surface wettability of a soft lens is an important property. The wettability aids in the closure of the lid over the lens, thereby improving comfort and preventing changes to the papillary surface on the internal surface of the lid.13 The very wettable surface creates a stable, even tear film. This assists with optimizing comfort, visual acuity, and deposit resistance. As silicone is naturally hydrophobic, its use in soft lenses created a dilemma until the ability to increase the wettability of silicone was discovered.

Early silicone hydrogel materials used a surface treatment to cover up the hydrophobic properties of silicone. Ciba Vision uses a gas plasma technique to apply a uniform plasma coating, approximately 25 nm thick with a high refractive index, on the surface of its silicone hydrogel lenses (lotrafilcon A and B) (Fig. 10.1). The gas plasma technique is also used by Bausch & Lomb to apply a plasma oxidation surface treatment to its silicone hydrogel lens (balafilcon A). This surface treatment results in glassy silicate islands on the surface of the lens. The islands leave small areas of exposed hydrophobic regions; however, the wettability of the silicate appears to create a bridge over these areas to produce a net hydrophilic surface.6 Menicon combines the benefits of plasma coating and plasma oxidation for a plasma surface treatment on its lens (asmofilcon A) called Nanogloss surface modification. The manufacturer reports that this creates a smooth surface with a low contact angle.10 Silicone hydrogel materials have also used an internal wetting agent, polyvinyl pyrrolidone (PVP), to create wettability (Vistakon, galyfilcon A, and senofilcon A).1 CooperVision reports that its silicone hydrogel lens (comfilcon A) has no surface treatment or wetting agent. Instead, the lens material contains two silicone-based macromers (a large monomer preassembled to transfer advantageous properties to the final polymer).6 These macromers, when incorporated into the material with hydrophilic monomers, result in a naturally wettable lens (Fig. 10.2).







▪ FIGURE 10.1 Silicone hydrogel surface modifications. (Courtesy of Ciba Vision.)







▪ FIGURE 10.2 Biofinity: Siloxane molecules attract and bond to surrounding water molecules, continuously wetting and lubricating the material. (Courtesy of CooperVision.)

Another factor that has changed the wettability of soft contact lenses is the incorporation of PVA or PVP, moisturizing agents, into daily disposable hydrogel lens materials. Potentially, adding these agents to the lens material will result in increased wettability, increased comfort, and enhanced tear film stability. Early results indicate that this may be beneficial to dry-eye patients and provide increased comfort throughout the day, including end-of-the-day comfort.14,15


Ionic Charge

Contact lens materials may possess an electric charge, or they may be electrically neutral. This attribute is especially important in soft lens materials, as it affects factors such as solution compatibility and deposit formation. Materials that have an electric charge are said to be ionic. The charge results from the presence of electrically charged groups in their chemical formulation. In most cases, this is an overall negative charge. The presence of a negative ionic charge causes the material to be more reactive, especially in solutions that are acidic. This, in turn, can cause dimensional changes and even material degradation.

An ionic charge may also cause a material to be more prone to deposit formation. Most deposits are positively charged substances from tears that are attracted to the negative ionic charge of the lens material. Materials that are electrically neutral are said to be nonionic. These materials tend to be more inert and less reactive with tear constituents, so they also tend to be more deposit resistant.


Hydration (Water Content)

Most contact lens materials, both GP and soft, absorb some water. The amount absorbed is usually expressed as a percentage of the total weight. When a material absorbs water, it swells, a fact that must be considered during the manufacturing process to achieve precise specifications. Materials that absorb <4% of water by weight are referred to as hydrophobic materials; those that absorb ≥4% water are termed hydrophilic polymers. With hydrophilic polymers (hydrogels),
increasing the water content generally increases Dk. However, this often increases lens fragility and may make the material more prone to deposit formation. Even if it were possible to create a 100% water content lens material, the Dk of water is 80; therefore, this lens would still be unable to meet the Holden-Mertz criterion for extended wear (87 × 10−9).1 Silicone hydrogel materials have low water contents, because the material is dependent on silicone, not water, to transmit oxygen.

Only gold members can continue reading. Log In or Register to continue

Stay updated, free articles. Join our Telegram channel

Jul 5, 2016 | Posted by in OPHTHALMOLOGY | Comments Off on Soft Material Selection/Fitting and Evaluation

Full access? Get Clinical Tree

Get Clinical Tree app for offline access