1.

Spesifikasi softlens
Spesifikasi softlens berdasarkan BS EN ISO 8321-2:2000 (BS 7208-24:2000) sebagai
berikut:
8.60:14.00, -3.00
8.60 = back optic zone radius (BOZR)
14.00 = total diameter (TD)
-3.00 = BVP
Material : Silicone Hydrogel
Kadar air 36%
Tabel 1. Toleransi softlens yang diijinkan
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. Toleransi material properti

Dimensi
Refractive index
Water content
Oxygen permeability

Toleransi
0.005
2%
20% (of nominal Dk)

2. Perbandingan Softlens dari berbagai merk

3. Synthesis and Development of Materials Softlens

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 the 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)

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)

Manufacturing Process of Softlens

Contact lenses may be produced by lathe cutting, or by cast molding process.
a. Lathe cutting
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 bulkpolymerised 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 postcured 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 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.

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.
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 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.

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.
The advantages of lathe cutting :
simple and easy operation
economically
many parameters available
The disadvantages of lathe cutting :
complex designs are more difficult
long operation
less production
b. Cast Molding

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

low cost operation

quick operation
product massal
complex designs are easy
high quality

The disadvantages of cast molding :

few parameters available

4. Product Design
Materials
Characteristics

Manufacturing

fluoroether macromer copolymerised (trimethylsiloxy)

methylsilane (TRIS) and N-vinyl pyrrolidone (NVP)
- TRIS : hydrogel polymer that characteristic include
optically transparent
- N-vinyl pyrrolidone (NVP) : hydrophilic, very
polar, continous wear
- Fluorine : increasing oxygen permeability
Cast moulding process:
A small amount of monomer is placed between two casts
to form the lens directly. The polymerisation process often
involves placing the lenses in an oven, during which time
they are subjected to a very fast temperature rise and
curing process. Rapid polymerisation times are likely to
produce shorter chains, more chain ends and less efficient
crosslinks. If the procedure is carried out in the presence of

oxygen (eg in a tunnel oven), oxygen can diffuse through

the casts and degrade the surface of the lenses. Cast
moulded lenses have a low volume to surface area ratio,
and thus, the oxygen degradation is likely to have a major
effect on the polymer network. Unlike lathed lenses and
like spun cast lenses, this degradation cannot be removed.
Polymerisation of the lenses in anaerobic conditions is
likely to reduce these surface effects. Alternatively,
polymerisation during cast moulding can take place in
anaerobic conditions and be initiated by UV light.
Characterizations

1. Atomic Force Microscope (AFM)

- Topography and roughness :
Surface roughness of devices contacting
living systems will influence their
biological reactivity. A smooth surface is
essential to promote biocompatibility
between softlens and the ocular surface.
2. Fourier Transform Infrared Spectroscopy (FTIR)
- Identify functional group of polymers
3. Thermogravimetric analysis (TGA)
- Compositional analysis of multi-component
polymers
- Measurement of low level of volatiles :
It is known that low levels of volatiles can
affect the injection molding processing of
polymers.
4. Mechanic (Tensile Strength)
- Measurement modulus :
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.

5. In theory the principle was simple, however, the difficulty lay in actually achieving
the combination in the laboratory.
Material problems :
- The silicone containing phase allows passage of oxygen whilst the water phase
primarily allows the lens to move. These lenses would be unsuitable for wear

due to the fact that the resultant material surfaces are not wettable by the tears.
These lenses are surface treated using gas plasma techniques.
Technical problems :

High energy gases or gas mixtures (the plasma) are used to modify the lens
surface properties can changing the bulk properties.

6. Project Flow Chart

Start

Material
Preparation

Manufacturing

Characterization

AFM

TGA

FTIR

Packaging

Finish

Mechanic (Tensile
Strength)