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Ultraviolet radiation transmission of soft disposable contact lenses and ISO

18369: claims and compliance

Article  in  Clinical and Experimental Optometry · February 2021

DOI: 10.1080/08164622.2021.1878826

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Preprint Accepted for publication in Clinical and Experimental Optometry 5 October 2020
Subject to Editors’ changes. The final published paper may not be exactly the same as here

RESEARCH

Ultraviolet radiation transmission of soft disposable contact lenses and ISO 18369: Claims and
compliance

Irene Jin, BOptom

Fiona Tao, BOptom
Lily Ho, BOptom(Hons) PGCertOcTher PGDAdvClinOptom GCU
Helen A. Swarbrick, PhD Dip Opt MSc FAAO
Stephen J. Dain, PhD BSc(Hons) FCOptom FAAO FRSN FIES(ANZ) FMSA

School of Optometry and Vision Science, University of New South Wales, Sydney, NSW, Australia

Running Title
UVR and contact lenses

Keywords
ultraviolet (UV) transmittance, contact lenses, spectrophotometer, eye protection, classification.
Purpose: This study was carried out to provide advice to eye care practitioners on those soft
disposable contact lenses that comply with the Class 1 or Class 2 requirements of the international
standard ISO 18369 for ultraviolet radiation (UVR) protection and to validate any claims made. It is
intended to be used when a patient needs or requests UVR protection.
Background: A revised ISO 18369-3 was published in 2017. There is no Australian adoption nor
equivalent.
Methods: The direct spectral transmittance of three specimens of each of the twenty soft disposable
contact lens types available in Australia in 2018 was measured in saline in a quartz cuvette with a dual
beam spectrophotometer from 200-780 nm. Transmittance values for each material were averaged and
scaled according to a single measurement of its transmittance in the visible spectrum (380-780nm).
Based on the ISO 18369-3:2017 criteria, lens materials were denoted as Class 1, Class 2 or non-UVR
protectors. This classification was compared with any claim made by the manufacturer.
Results: All claims of the manufacturers for Class 1 or Class 2 were valid. There were no examples of
any missed opportunity to make a claim. Some claims were so general as to be untestable. Some
numerical claims appeared to hide that only a Class 2 claim could be made.
Conclusions Claims of Class 1 or Class 2 were found to be appropriate. There were no missed
opportunities to claim. UV protection claims that were not in the ISO 18369-3 format may be taken as
Class 2 compliance but not Class 1 compliance. A two class system of UV protectors and non-UV
protectors may serve practitioners and their patients better.
The impact of acute and chronic ultraviolet radiation (UVR) exposure to the human eye includes skin
cancer of the eyelids, pingueculae, pterygia, photokerato-conjunctivitis, climate droplet keratopathy,
cataracts and solar retinopathy.1 Contact lenses with UVR absorbing qualities have been considered as
a viable protective option and studies have confirmed that only those with sufficient UVR absorbing
qualities are suitable as protection.2,3 There are many previous studies 4-17 on contact lens UVR
transmittance but none has assessed the contact lenses with respect to the international standard ISO
18369-118 in part because some studies predate the ISO standard that was first published in 2006. A
small number of lenses have been assessed with respect to the USA standard, ANSI Z80.20, which
has identical requirements 19,20 and was first published in 1998. The publication of a revised
international standard, ISO 18369-321, the test method standard, has prompted this study.
Commercially available soft disposable contact lenses available in Australia in 2018 were studied.
The spectral transmittances were measured in the UV region (280-380 nm). ISO 1836921 sets out a
class system of UVR protection claims. Class 1 blockers must have less than 10% UVA (315-380 nm)
transmittance and less than 1% of UVB (280-315 nm) transmittance and Class 2 blockers must have
transmittance of UVA less than 50% and UVB less than 5%. These requirements are the same as the
USA standard20 and ISO 18369-3 has been adopted identically as a European Standard, EN ISO
18369-3 and, as a consequence, as national standards in the countries of the European Committee for
Standardization (CEN). The 2006 edition was adopted as an Indian Standard.22 Standards Australia
has not adopted any of the ISO 18369 series at this stage.
MATERIALS AND METHOD
Three specimens of each of twenty soft disposable contact lens designs were obtained from their
respective manufacturers at different times to minimize batch sampling variations. The material and
commercial names of the contact lenses studied are listed in Table 1. All the contact lenses were -
3.00D, being the power typically chosen by most contact lens researchers for study and having
sufficient rigidity to allow positioning in the test cuvette. Optical density is proportional to lens
thickness (Beer–Lambert–Bouguer Law23) so by measuring the spectral transmission at the centre of a
-3.00DS lens, which is the thinnest area of a negative power lens, the maximum transmittance is
obtained. For a negative power lens, there will be less UVR transmission peripherally given the
thicker lens mid periphery and the reverse is true for a positive power lens.
To measure the spectral transmittance, an Evolution 600 UV-Visible dual beam spectrophotometer
(Thermo Fisher, Waltham, MA, USA) was used. Matched quartz cuvettes were placed in the test and
reference beams. They were filled with normal preserved saline solution. In front of each cuvette was
a limiting aperture 2 mm vertically and 6 mm horizontally. These limited the spectrophotometer beam
(12 mm x 2 mm) to an area 2 x 2mm that was unaffected by beam wander during the spectral scan.
The method has been reported previously.24,25
The wavelength accuracy of the spectrophotometer has been established as ±0.5 nm using calibrated
holmium oxide and neodymium filters.26 The linearity has been established as ±0.25% (with the
masks and cuvettes in place) using glass neutral density filters calibrated by the Optics & Radiometry
Laboratory, which is an ISO17025 accredited calibration laboratory (National Association of Testing
Authorities, Australia accreditation number 1923). The zero baseline noise is 0.05% absolute. The
test-retest (remove-replace) repeatability is 1%. These combine to an uncertainty of measurement that
comprises these three portions, the wavelength accuracy (∆l = 0.5 nm), a fixed component (0.05%)
and a proportion of the measured transmittance (0.0125). The resultant uncertainty of measurement
of spectral transmittance, (UNC(l)), is wavelength dependant,
Δ𝜏%
𝑈𝑁𝐶(𝜆)% = 0.5 ∙ + 0.05 + 0.0125 ∙ 𝜏%
Δ𝜆
The values of spectral transmittance are then averaged as the UVA and UVB values and the
broadband uncertainties calculated by a series of worst-case scenarios. As a consequence, the values
of uncertainty of the broadband values depend in a complex way on the spectral values of uncertainty
and transmittance and a single, global, value does not exist.
ISO 18369-3:201721 does not require uncertainty of measurement to be taken into account when
assessing compliance but many other ISO standards do and an ISO/IEC 17025 accredited
laboratory,27 is required to take uncertainty of measurement into account. If a measurement of 49.5%
transmittance with an uncertainty of measurement ±1% (absolute) is found and the requirement for
compliance is a maximum of 50.0%, at first sight the measurement might be thought to show a pass,
but the result is not unambiguously less than 50.0%. In the ISO standards that do require that
uncertainty of measurement is taken into account, this would be required to be reported as a fail. We
report it as borderline.
For the UVR region, spectral transmittance measurements were made in the range 200-380 nm at
1 nm intervals with a 1 nm spectral half bandwidth and 60nm/min scan speed. The UVR
transmittance was measured on three samples of each lens type, with fresh saline for each
measurement.
For the visible light region, spectral transmittance measurements were made in the range 380-780 nm
at 5 nm intervals and 4nm spectral half bandwidth with 120nm/min scan speed. This measurement
was performed once for each contact lens design. Between sample measurements the 100% baseline
was remeasured without a contact lens in the test beam cuvette. The procedure includes the ISO
18369-3:2017 requirements.21
Data from the spectrophotometer were exported using the Optlab SPX ver 2.6 data collection software
on the spectrophotometer computer and analysed using a custom spreadsheet in Microsoft Excel.
RESULTS
Figure 1 shows the spectral transmittances of three representative contact lenses. The solid line
represents a contact lens that is not a UVR absorber in the meaning of ISO 18369:2017. The dotted
line is a Class 2 contact lens example and the third is a Class 1 contact lens example. The mean
percent UVR transmittance in the UVA (316-380nm) and UVB (280-315nm) regions for each lens are
presented in Table 1. This table also states whether the lens is a Class 1, Class 2 or non-UV blocker
based on the ISO standard. In the case in which the lens manufacturer has claimed a certain level of
protection, we have also indicated if this claim was validated by our data.
DISCUSSION
Many studies have evaluated the transmittance of both claimed UV-blocking and non-UV-blocking
contact lenses to assess their appropriateness as eye protection but without referring to ISO 18369-1.
In this study, all claims of UV Class 1 and 2 were found to be valid. No claims were made for lenses
that could not achieve a class. For these lenses, the provisions of ISO 18369-121 have been correctly
applied. This represents 81% of the sample.
CooperVision made a claim for Avaira of 70% UVA and 96% UVB protection. This was found to be
a valid claim. These lenses could be claimed as Class 2 UV protectors.
Verification of the claims of Bausch & Lomb for BioTrue to have UVA and UVB protection was not
possible because the claim did not include a testable numerical claim. These lenses could be claimed
as Class 2 UV protectors.
Verification of the claims of CooperVision for Clariti 1 Day to have UVA and UVB protection was
not possible because the claims did not include a testable numerical claim. These lenses complied
with the Class 2 requirements for UVA transmittance but the UVB transmittances fell close to the ISO
18369-1 limit for Class 2 and application of the uncertainties of measurement means that a pass or fail
cannot be reported. If uncertainties of measurement are taken into account, only one specimen met
Class 2.
CooperVision claimed MyDay as having a ‘UV inhibitor’. The significance of this claim is not
evident, as it is not a quantitative claim. As a consequence, it is also an untestable claim. All three
specimens complied with the Class 2 requirements.
The Class 1/Class 2 system provides a simple, clear and understandable guidance to clinicians and the
public. Alternative numerical claims serve only to confuse. Is “70% UVA and 96% UVB protection”
better or worse than Class 1 or Class 2? The lenses were actually Class 2.
Unverifiable, qualitative terms are entirely unhelpful, especially when compliance with Class 1 or 2
requirements cannot be demonstrated.
Our study highlights that contact lenses are not all equal in their UVR blocking abilities. The issue of
manufacturers making claims with valid basis to permit product comparison is also addressed.
However, contact lenses alone should not be relied on to provide UVR protection, as they give no
protection at all to the conjunctival epithelium and peri-orbital structures.
Despite the evident reduction in UVR reaching the eye with UVR blocking contact lenses, there has
not been an in-vivo human clinical study that correlates them to the prevention or delay of UVR
related ocular diseases. The prevention of UVR-induced changes to corneal and lens cells have been
established in animal and in-vitro human cells studies2,4 but longitudinal in-vivo human studies are
required.
There is no need, from an eye protection point of view, to have a two class system. All that is required
is sufficient UVR protection. An even simpler message to the clinician and public is, therefore, to
have a UV protective lens and a non-UV protective lens unless there is guidance given on the
circumstances when the UVR protection of a Class 2 lens is sufficient and the circumstances where it
is not and the greater UVR protection of the Class 1 is necessary.

CONCLUSION
UVR blocking contact lenses are, and will continue to be, clinically relevant given the raised
awareness of the impact of UVR damage to human eyes. Our study has confirmed that not all
currently available contact lenses on the Australian market have UVR protection in the meaning of
ISO 18369.18
All claims of Class 1 or 2 were found to be valid. No manufacturer missed the opportunity to claim a
class, that is, the absence of a claim consistently indicated that a class was not claimable.
The use of a claim not using the ISO 18369 format could be interpreted as avoiding a claim of the
lesser level of Class 2. These generalized and untestable claims are problematic.
The three categories outlined in the internationally agreed ISO 1836918,21 (no claim/Class 2/Class 1)
are simple and easily understood, which is important for clinicians and for providing public
awareness. It is unfortunate that not all manufacturers use ISO 18369 for their claims.
A single class system is simpler and, from a hazard analysis point of view, more correct.
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 Corresponding author: Stephen J. Dain. s.dain@unsw.edu.au

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