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6.633.

Development of Contact Lenses from a


Biomaterial Point of View Materials, Manufacture,
and Clinical Application
N Efron, Queensland University of Technology, Kelvin Grove, QLD, Australia
C Maldonado-Codina, The University of Manchester, Manchester, UK
2011 Elsevier Ltd. All rights reserved.

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Appendix A.
A.1.
A.2.
A.3.
A.3.1.
References

Glossary

Introduction
General Properties of Hydrogel Materials of Relevance to Contact Lenses
Optical Transparency
Mechanical Properties
Surface Properties
Water Content
Oxygen Permeability
Fluid and Ion Permeability
Refractive Index
Swell Factor and Dimensional Stability
Conventional Hydrogel Contact Lens Materials
Historical Development
Polymeric Formulations
High Water Content Hydrogel Lenses
Strategies for Enhancing Lens Comfort
Silicone Hydrogel Contact Lens Materials
The Drive for Increased Corneal Oxygenation
The Challenge of Incorporating Silicone into Hydrogel Materials
The Launch of Silicone Hydrogel Lenses
Surface Treatments
Material Modulus of Elasticity
Lens Edge Design
Second Generation Silicone Hydrogel Lenses
Optimizing Surface Characteristics
Classification of Soft Contact Lens Materials
Soft Contact Lens Manufacture
Lathe Cutting
Spin Casting
Cast Molding
Reproducibility and Quality of Mass-Produced Lenses
Clinical Ramifications of Polymer and Manufacturing Developments
Polymer Developments: Enhanced Corneal Oxygenation
Manufacturing Developments: Planned Lens Replacement
Conclusions
Classification of Soft Lens Materials
FDA Classification System
ACLM Classification System
BS EN ISO 18369-1: 2006
Example

Conjunctival staining Disruption of the superficial


Conjunctiva Clear transparent vascularized protective tissue epithelial layer of the conjunctiva, as revealed by an

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Other Surgical Disciplines: Ophthalmology

Contact lens A clear, transparent shell-like optical


appliance that is placed on the front of the eye to correct
errors of refraction of the eye.
Cornea The clear transparent tissue at the front of the eye
through which light passes to form an image at the back
of the eye.
Corneal staining Disruption of the superficial epithelial
layer of the cornea, as revealed by an orange dye
(fluorescein) that is inserted into the eye. Fluorescein fills
spaces created by tissue damage, and the pooled dye
displays a bright green fluorescence when illuminated
with blue light, revealing the location of tissue damage.
Endothelial cell density The number of endothelial cells
per unit area of the endothelial surface.
Endothelial polymegethism Change in appearance of the
endothelium, whereby the cells in this layer display a
large variation in cell size.
Endothelium Single layer of highly metabolically active
cells at the back of the cornea. The cells all appear to be
of uniform size and display, and characteristic hexagonal
shape.
Epithelium Superficial layer of cellular tissue of an organ,
such as the cornea.
Epithelial microcysts Small cystic spheres that form within
the corneal epithelium, when subjected to hypoxic stress.
Epithelial oxygen uptake The movement of oxygen into the
cornea, from either the atmosphere in front of the eye, or
the aqueous humor (the fluid inside the eye).
Fluorescein staining A term describing the use of
fluorescein to reveal the presence of tissue damage in
the cornea or conjunctiva (see corneal staining and
conjunctival staining).
Microbial keratitis Inflammation of the cornea caused by
infection with microorganisms. This inflammatory
process can result in opaque scar formation on the
cornea, thus

impeding the passage of light into the eye, resulting


in partial or complete vision loss.
Mucin balls Small spherical balls of mucin, derived from
mucin in the tear layer, that form between the back of
the lens and front of the cornea, during lens wear.
Myopia Nearsightedness, whereby the image of a distant
object in space is focused in front of the light-sensing
retina at the back of the eye. This is corrected using minus
powered ophthalmic lenses.
Papillary conjunctivitis An inflammation of the vascular
mucous tissue on the inside of the eyelid, caused by
irritation of the front surface of the contact lens, especially
of the lens surface if contaminated with deposits.
Prelens tear film The thin layer of tears that covers the
cornea and conjunctiva of the eye.
Presbyopia The reducing ability of the eye to focus on close
objects, caused by a thickening and loss of flexibility of
the lens inside the eye.
Stroma Forms the bulk of the middle of the cornea,
consisting of collagen fibrils and
mucopolysaccharide ground substance.
Superficial epithelial arcuate lesions (SEALs) Arc-shaped
lesion of the superficial tissue of the cornea, occurring at
the surface of the cornea. This is a transient form of tissue
damage that is self-limiting; that is, it heals by itself
within 24 h if the lenses are removed.
Trial fitting The process of sequentially applying contact
lenses with different characteristics (curvature, diameter,
thickness, material, etc.) to the eye and assessing lens
behavior on the eye (stabilized position, movement with
blink, etc.) until a lens fitting of satisfactory performance is
achieved.
Xerogel The anhydrous polymer from which soft lenses
may be made; water needs to be added to turn the
xerogel into a functional hydrogel.

Methacryloyloxyethyl Abbreviations
FM0411M
iminocarboxyethyloxypropyl
(dimethylsiloxy)-butyldimethylsilane
Glyceryl methacrylate
Association
ACLM
ofpoly
Contact
Lens Manufacturers
Glyceryl methacrylate
methacrylate
(UnitedHydroxyethyl
Kingdom) Atomic
force microscopy Alkyl methacrylate
2-hydroxybutyl
methacrylate
Isobornylmethacrylate
Butyl
(probably
isobutyl)
methacrylate British Standards
AFM
GlyMA
International AMA
Standardization
Organization Bis(methacryloyloxyethyl
iminocarboxy
poly(dimethylsiloxane)-po
Cyclohexyl
methacrylate
BMA BS CMA
GMA
HEMA HOB ethyloxypropyl)
IBM ISO M3U
Methacrylic acid
Methyl
methacrylate
Oxygen
permeability
(diffusivity
[D]
Dk
Monofunctional polydimethylsiloxane
solubility [k])
N-carboxyvinyl Oxygen
ester
transmissibility (Dk divided by thickness [t])
National Patent Diacetone
Development
Corporation
acrylamide
N,N-dimethyl acrylamide Ethoxyethyl methacrylate
Ethylene glycol dimethacrylate European Norm

EWC FDA Dk/t

MAA
MMA MPDMS NCVE NPDC

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