SOFTLENS SPESIFICATION

Based on BS EN ISO 8321-2:2000 (BS 7208-24:2000)

8.60:14.00, -3.00
8.60 = back optic zone radius (BOZR)
14.00 = total diameter (TD)
-3.00 = BVP
Material : Silicone Hydrogel
36% water content
Table 1. Softlens Spesification
BOZR
Total diameter
Central optic zone diameter
Sag at specified diameter
Thickness
0.10 mm
> 0.10 mm
BVP in weaker meridian
Plano to 10.00 D
10.00 D to 20.00 D
Over 20.00 D
Cylinder power
Plano to 2.00 D
2.25 D to 4.00 D
Over 4.00 D
Cylinder axis

0.20 mm
0.20 mm
0.20 mm
0.05 mm
0.01 mm + 10%
0.015 mm + 5%
0.25 D
0.50 D
1.00 D
0.25 D
0.37 D
0.50 D
5

Tabel 2. Material Property Tolerance

Dimension

Tolerance

Refractive index

0.005

Water content

2%

Oxygen permeability

20% (of nominal Dk)

SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

Table 3. Material Property Silicone Hydrogel

Brand

Air Optix

Purevision Acuvue

Material
(USAN)

Night & Day

lotrafilcon A balafilcon
A

Air Optix

Acuvue

Biofinity

Avaira

PremiO

Acuvue

Definitive

Advance
galyfilcon A lotrafilcon
B

OASYS
senofilcon
A

comfilcon
A

enfilcon
A

asmofilcon
A

TruEye
narafilcon
A

efrofilcon
A

Clariti 1

Dailies

SilO

Day
filcon II 3

Total 1
delefilcon
A

Wet
lucifilcon
A

Year
1999
Manufacturer Alcon Vision
Care

1999
Bausch &
Lomb

2003
J&J Vision
Care

2004
Alcon
Vision
Care

2005
J&J Vision
Care

2006
Cooper
vision

2009
Cooper
vision

2007
Menicon

2009
2008
J&J Vision Contamac
Care

2011
Sauflon

2012
Alcon
Vision
Care

2013
Paragon
Vision
Science

Dk

140

99

60

110

103

128

100

129

100

60

60

140

60

Central
Thickness
@3.00 D
(mm)
Dk/t (barrer/
cm)

0.08

0.09

0.07

0.08

0.07

0.08

0.08

0.08

0.085

0.08

0.07

0.07

0.08

175

110

86

138

147

160

125

161

125

75

86

156

50

EWC (%)

24

36

47

33

38

48

46

40

46

74

58

32

65

Ionic
(FDA group)
Surface
Treatment

No (I)

Yes (III)

No(I)

No(I)

No(I)

No(I)

No(I)

No(I)

No(I)

No(II)

No(II)

No(I)

No(II)

Plasma
oxydation

No

No

No

Plasma
oxidation

No

No

No
disclosed

No

No

1.1

0.43

Plasma
No
polymerization
1.2
0.72

0.8

0.5

0.91

0.66

0.35

0.5

0.7

0.443

0.028

0.361

0.024

0.057

0.018

0.207

0.014

95

65

78

68

Plasma
polymerizaTion
Elastic modu- 1.4
lus (MPa)
Friction
0.394
coefficient
Contact
80
Angle()

Sources: manufacturer information; - Ross G et al.[10]; Tighe B.[11]; Roba et al. [12]; Jacob J. [13]; Karlgard et al.[6]; Tighe B.[14]
FDA: Food & Drug Administration; USAN: United States Adopted Names Council; EWC: equilibrium water content; Dk: oxygen permeability in barrers 10 11 (cm2/sec)[mL O2(STP)/(mL x mmHg)]; Dk/t= barrer/cm;
Pa: pascal; MPa: megapascal; 1Pa = 1 N/m2; 1 kPpa = 103 N/m2 1 MPa = 106 N/m2 = 100 N/cm2 = 145 psi

SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

SOFTLENS MATERIAL
A contact lens polymer is a complex structure that consists of high molecular weight entities
crosslinked in a three-dimensional amorphous network. If we can imagine polymer molecules
as pieces of string loosely entangled, their interaction and entanglement governs polymers
physical properties. The first step in the manufacture of contact lens is the polymerization of
the material. Polymerization is the process by which monomers are combined in the presence
of crosslinkers and initiators in order to create a stable structure. In Si-Hy materials the main
chain contains siloxane derivates such as:
polydimethylsiloxane (PDMS)
(trimethylsiloxy)methylsilane (TRIS)
tris-(trimethylsiloxysilyl) propylvinylcarbamate (TPVC)

Fig 1. Si-Hy materials the main chain

These and other materials also found in conventional hydrophilic contact lens materials, such
as :
N,N-dimethyl acrylamide (DMA)
glycerol methacrylate (GMA)
2-hydroxy-ethyl methacrylate (HEMA)
methacrylic acid (MAA)
methyl methacrylate (MMA)
N-vinyl pyrrolidone (NVP)

SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

Fig 2. hydrophilic contact lens materials the main chain

SOFTLENS MANUFACTURE
Contact lenses may be produced by lathe cutting, or by cast molding process.
1.
Lathe cutting
a.
Sample preparation
The first step in the lathing process is the preparation of the material that will
eventually be lathed into the final contact lens. Monomers are usually bulk-polymerised into
individual button-shaped moulds or cast into rods from which buttons can then be sliced.
Polymerisation is usually a slow process and buttons or rods are typically left in a water bath
for several hours at a specified temperature which will vary with the material being cured.
Once cured, buttons are usually post-cured or annealed. This involves heating the material to
above its glass transition temperature and then cooling it back down to near room
temperature. The purpose of this step is to soften the material which in turn has the effect of
relieving stress in the buttons. If this step was not carried out the swelling behaviour of the
SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

buttons would be very unpredictable. Annealing also prevents other effects that are sometimes
seen in finished lenses, such as fluting of lens edges or rolling up of lenses like a cigarette
when hydrated. When a soft contact lens is lathed, it is done so in the dry state. This means
that a smaller, steeper lens of greater power is made so that when it is hydrated, it swells to
the required dimensions and powers.

Fig 3. Lathe cutting process

b.

Back surface cutting of a lens blank

The next step in the process is the cutting of the lens back surface from the buttons (or
lens blanks), usually on a computer numerically controlled (CNC) lathe. The lathes can be
programmed to cut innumerable design and parameter variations. The back surface is cut
using diamond cutting tools. The first cut is a rough cut, performed by a roughing tool which
removes most of the excess button material and then a finishing tool performs the final cut
which will usually cut secondary curves and edge bevels. The whole process takes only a few
minutes. Following on from this, the back surface is polished on a polishing machine. The
composition of the polishing compound will vary between manufacturers, but it is typically
made up of a lanolin base with abrasive diamond dust. The semifinished lenses are dipped
into a solvent to remove the polish.
c.

Front surface cutting of a lens

The next step in the process is blocking. The semifinished lens blank is attached by
the newly formed back surface to a front surface chuck by means of hot, melted wax. When
the wax cools and solidifies, a strong bond is formed between the chuck and the lens blank.
The lenses are loaded back on to the lathe for front surface cutting. A diamond tool will
generally cut about 7000 lenses before it needs to be replaced.The front lens surface is
polished and then deblocked by immersing the arbor with the attached contact lens into a
deblocking solvent. All of the procedures described so far place enormous demands on the
material. The mechanical properties of the material must be such that it is able to cope with
SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

high speed cutting and polishing. The process (in particular the generation of heat) places a
lower limit on the glass transition temperature of the polymers used. For example, if the glass
transition temperature of a material were very low, the buttons would be soft at room
temperature and consequently very difficult to lathe. It is equally important that the material
is not too brittle, this would lead to cracking and breaking of the lenses during the process.
d.

Wet processing of the lenses

The dry lenses undergo hydration and wet processing. Hydration steps will vary
according to which material the lens has been made from. Most non-ionic lenses will be
washed in deionised water (perhaps containing a surfactant) and then saline. These steps are
often carried out in ultrasonic baths to speed up the hydration process. If the lens material
contains MAA, the lenses will be washed in tanks containing sodium bicarbonate in order to
ionise the lenses.
e.

The advantages of lathe cutting

simple and easy operation
economically
many parameters available

f.

The disadvantages of lathe cutting

complex designs are more difficult
long operation
less production

2.

Cast Molding

SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

Fig 4. Cast Molding process

a.

Insert manufacturer
Tooling is again the key to successful contact lens fabrication using this manufacturing
method. For cast moulding, both a male and a female insert need to be made as well as the
auxiliary insert housings. The female cast (formed by the female insert) creates the front
surface of the final contact lens and the male mould (formed by the male insert) creates the
back surface of the final lens. Relatively few male inserts are made since a particular lens will
usually only be available with a limited number of BOZR options. However, hundreds of
female inserts are made. It is by changing the female insert that different powers of lenses
will ultimately be obtained. It is by changing the female insert that different powers of lenses
will ultimately be obtained because this changes their front surface radii and overall thickness
profile.
b.

Cast Manufacturer
Typically, hundreds of casts are made every hour. The material that the casts are made
from is integral to the manufacturing process. In the past, manufacturers have had problems
with the dimensional stability of casts. This manifests itself in a low yield of lenses at the
correct specification for a particular batch. It is vital, therefore, that the chemical structure of
the polymer used is carefully selected. The Ciba Vision Lightstream production method
uses glass moulds. The design of the casts is critical to the final form of the lens. The cast
design will determine not only the surface curvatures, optical quality and the diameter of the
lens, but also the edge design of the final lens. The reproducibility of a particular lens,
particularly the edge quality, is directly related to the cast design. The patent literature is full
SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

of patents which describe different designs for cast manufacture, all using slightly different
techniques for forming the edges of a lens.
c.

The advantages of cast molding

low cost operation
quick operation
product massal
complex designs are easy
high quality

d.

The disadvantages of cast molding

few parameters available

DEVELOPMENT FOR MATERIAL SOFTLENS

1.

Silicone Hydrogel Synthesis

The silicone hydrogel was produced by following the synthesis procedure developed
by Kim et.al. Briefly, 3 ml of mixture of TRIS, bis-alpha,omega-(methacryloxypropyl)
polydimethylsiloxane and DMA with the ratio 4:1:2 was combined with 0.18 ml of NVP, 15
ml of EGDMA and 0.3 ml ethanol. Then the mixture was purged with dry nitrogen for 15
min. 8 mg of photoinitiator was then added to the mixture and stirred for 5 min. For
photopolymerization, the mixture was also drop-wisely added on the surface of cover glass
but was irradiated for 50 min by UV for complete crosslinking. The hydrogel was washed
byethanol and dried in air overnight.

a)

SILICONE
MATERIAL

b)

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

Fig 5. (a) Spin casting silicone hydrogel (b) Silicone hydrogel Polymerization
2.

PEG Coating by MAPLE

Before PEG deposition by MAPLE, the silicone substrate was treated with oxygen
plasma to remove extra chemical residues. Silicone hydrogels were etched in STS Reactive
Ion Etch with the 13.56 MHz system and the plasma power 90 W for 10 min on each side.
For target preparation, 4% wt PEG was dissolved in iso-propanol and then injected
into the target holder in the vacuum chamber. The solution was then freezed by liquid
nitrogen. After the target solution was totally frozen, the vacuum chamber was pumped out to
nearly 10-6 Torr. At this time target movement and laser emission started, while the substrate
was covered by substrate cover in order to clean the target surface. After 1 min the substrate
movement started and the substrate cover removed to initiate the deposition.
The laser used for irradiation has the wavelength of 532 nm and the frequency 10 Hz
and the fluency approximately 1 J/cm2. The laser spot on the target is about 0.15 cm 2 and the
distance between target and substrate is 7 cm. The substrate has the temperature of about 32 oC
during the deposition. The pressure inside vacuum chamber increased to about 10-5 Torr after
150 min deposition.

MATERIAL CHARACTERIZATION
1.

Fourier Transform Infrared Spectroscopy (FTIR)

SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

Fig 6. FTIR Spectrum for silicone hydrogel-PEG (*air dried PEG)

The deposited PEG on silicone surface was examined by FTIR in comparison with the
blank silicone and silicone with air dried PEG on the surface as well as pure PEG molecule
(figure 6). Compared to silicone hydrogel, silicone with MAPLE and air dried PEG have
more significant band at 3410 nm, which represents the stretching of hydroxyl group in PEG.
Both of them also show broad shoulder at band from 2900 nm to 2850 nm compare to the
pure silicone. We speculated that this is due to the affection of alkane group stretching in PEG
at the band of 2865 nm. This result proves that the PEG molecules have been successfully
deposited on the surface of silicone hydrogels without significant chemical structure damage.
2.

Atomic Force Microscope (AFM)

AFM was used to measure the roughness and thickness of the PEG thin film on the
surface of cover glass. It can be found that PEG molecules form islands rather than films on
the cover glasses. The islands density after 2 hours deposition (figure 7.2b) is higher than that
after 1 hour deposition (figure 7.2a). The PEG islands on cover glass have the diameter of
about 0.7 m and the thickness of about 33.3 nm after 1 hour deposition, but after 2 hours
deposition, the spots grows from 0.7 m to nearly 3 m and the maximum thickness to about
357 nm.
It can be observed that the deposited PEG molecules tend to form scattered islands
rather than homogeneous thin films on the surface of cover glass. We speculate that the
surface property (hydrophilic or hydrophobic) of cover glass may have important efforts for
PEG film homogeneity. Surface pre-treatment such as oxygen plasma may be needed before
MAPLE deposition. Other parameters, such as the target and substrate distance, deposition
time and the substrate temperature, may also affect the film homogeneity.

SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

Fig 7. PEG Coating (a) after 1 hour deposition (b) after 2 hour deposition
3.

BSA Adsorption
The BSA adsorption of silicone hydrogel before and after PEG deposition by MAPLE
technique was measured by using BCA assay. It can be found in figure 8 that after PEG
deposition, the protein adsorption of silicone decreased to approximately one third compared
to pure silicone gel. This result shows that PEG thin film has significant effect to enhance
BSA resistance of the substrates. This indicates that the PEG layer has a significant effect on
improving the resilience of silicone hydrogel BSA, because the protein deposits on the lens
surface increase the adhesion of bacteria such as Pseudomonas aeruginosa (Butrus,1990).

Fig 8. BSA Adsorption (1) silicone hydrogel (b) silicone hydrogel- PEG
4.

Mechanic (Tensile Strength)

It is important to appreciate that modulus is a property of the material rather than the
contact lens. The lens thickness and geometry will also have a bearing on its mechanical
behaviour. A thick lens made from a low modulus material may still be considered relatively
inflexible or stiff. A thinner lens made from a low modulus material will drape over the
cornea, distributing itself evenly on the ocular surface with minimum lid interaction.

SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS

The stress and strain produced in order to understand the Stress-Strain curves of
different samples and their Youngs modulus (E)

Table 4. Youngs Modulus (E) of Materials

Silicone
0.62

E (MPa)

Silicone-PEG
0.69

MATERIAL SOFTLENS PROBLEMS

The material softlens problems that occurs in contact lens is deposit. Types of deposit such as:
Protein
Protein is a white membrane or fine mist evenly on the surface of the contact lens caused by
excessive protein in tears.
Lipid
Lipid is a state of greasy, slick and shiny on the surface of the contact lens caused by excess
oil in tears.
Jelly bump
Jelly bump is a aglomerate that transparent 2-3 mm and penetrate the surface of contact lenses
by comparing combined oil and calcium overload in tears.
Micro organisme growth
Micro organisme growth is a collection of fungi in gray and branching on the surface of
contact lens caused by disinfection process or immersion unfavorable.

DESIGN PROJECT
Start

Material
Preparation
SILICONE
MATERIAL

HYDROGEL-PEG

AS

SOFTLENS
Manufacturing

ANTI MICROBIAL

Characterization
AFM

Packaging
Finish

Mekanik (Tensile
Strength)

BSA

FTIR

Fig 9. Flow Diagram

SILICONE
MATERIAL

HYDROGEL-PEG

ANTI MICROBIAL

AS

SOFTLENS