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  6. Evalution Examples of Contact Lenses

Evalution Examples of Contact Lenses

Evalution Examples of Contact Lenses

Observation of pigments distribution in color contact lenses, observation of edge shape of contact lenses(cross section) :Fig.1

Using microscope, we can observe the cross section of swollen state soft contact lenses in physiological saline.

Pigments distribution

Fig.2 shows expansion of part A and B of Fig.1. Distribution and presence of pigments can be observed. In this example, the pigments are presented about 100µm thickness at the side of eyelid. We perform size measurement of outer and inner diameter of colored part, and leachable materials test.

Microscopic observation of edge part

Fig.3 shows expansion of part C of Fig.1. The edge shape affects irritation to cornea and movement characteristics in eyes, it is important to control the edge shape of contact lenses.

Tensile test (physical characteristics and mechanical testing) on soft contact lenses

A tensile test is one of the items required for approvals of soft contact lenses. (Fig.1)
We can test the tensile strength of curve-shaped products without producing flat plates made of lens materials. In this test, the tensile of used sample is lower than the new one.

Other tests for soft contact lens required for approval

We provide various tests required for approval related to soft contact lenses and non-corrective contact lenses in short time. We promote the improvement of technologies by introduction of oxygen permeability equipment for soft contact lenses using electrode method.

demand items testing items cited standards
physical characteristics Shape and outward appearance ISO 18369-3
Diameter ISO 18369-3
Thickness ISO 18369-3
Base curve ISO 18369-3
Vertex diopter ISO 18369-3
JIS B 7183
Luminous transmittance ISO 18369-3
JIS Z 8722
Oxygen permeability coefficient ISO 18369-4
Strength JIS K 7127
(JIS K 7113)
Refractive index ISO 18369-4
(JIS K 7105)
Water content JIS K 7209
ISO 18369-4
Cylindrical refractivity and cylindrical axes JIS B 7183
Prism error JIS B 7183
chemical characteristics Extractables ISO 18369-4
Monomer residue, additives, colorants  
disinfectant compatibility Test for leaching of monomer components, colorants and UV absorbents, Residual property, accumulation, leachability of chemical disinfectant to lens, PAB Notification No.645 dated March 31, 2011
biological characteristics Cytotoxicity JIS T 0993-1
Sensitization JIS T 0993-1
Irritation/intracutaneous reactivity JIS T 0993-1
Ocular study using rabbit eyes ISO 9394
Genotoxicity JIS T 0993-1
demand for stability Product stability test ISO 11987

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