ANSI Z80.30-2010 For Ophthalmics - Toric Intraocular Lenses (VC).pdf

1、American National Standardfor Ophthalmics Toric Intraocular LensesANSI Z80.30-2010ANSIZ80.30-2010ANSIZ80.30-2010American National Standardfor Ophthalmics Toric Intraocular LensesSecretariatThe Vision CouncilApproved March 24, 2010American National Standards Institute, Inc.Approval of an American Nat

2、ional Standard requires review by ANSI that therequirements for due process, consensus, and other criteria for approval havebeen met by the standards developer.Consensus is established when, in the judgement of the ANSI Board ofStandards Review, substantial agreement has been reached by directly and

3、materially affected interests. Substantial agreement means much more thana simple majority, but not necessarily unanimity. Consensus requires that allviews and objections be considered, and that a concerted effort be madetowards their resolution.The use of American National Standards is completely v

4、oluntary; theirexistence does not in any respect preclude anyone, whether he has approvedthe standards or not, from manufacturing, marketing, purchasing, or usingproducts, processes, or procedures not conforming to the standards.The American National Standards Institute does not develop standards an

5、dwill in no circumstances give an interpretation of any American NationalStandard. Moreover, no person shall have the right or authority to issue aninterpretation of an American National Standard in the name of the AmericanNational Standards Institute. Requests for interpretations should beaddressed

6、 to the secretariat or sponsor whose name appears on the titlepage of this standard.CAUTION NOTICE: This American National Standard may be revised orwithdrawn at any time. The procedures of the American National StandardsInstitute require that action be taken periodically to reaffirm, revise, orwith

7、draw this standard. Purchasers of American National Standards mayreceive current information on all standards by calling or writing the AmericanNational Standards Institute.American National StandardPublished byThe Vision CouncilZ80 Secretariat225 Reinekers LaneAlexandria, VA 22314Copyright 2010 by

8、The Vision CouncilAll rights reserved.No part of this publication may be reproduced in anyform, in an electronic retrieval system or otherwise,without prior written permission of the publisher.Printed in the United States of AmericaDeveloped byThe Accredited Committee Z80 for Ophthalmic StandardsThe

9、 Vision CouncilZ80 Secretariat225 Reinekers LaneAlexandria, VA 22314iContentsPageForewordiii1 Scope and purpose12 Normative references.13 Definitions24 Physical requirements24.1 Scope.24.2 Requirements.24.2.1 Tolerances and dimensions.25 Optical requirements35.1 Scope.35.2 Requirements.35.2.1 Dioptr

10、ic power35.2.2 Axis orientation mark(s).35.2.3 Imaging quality.35.2.4 Spectral transmittance.46 Mechanical requirements.46.1 Scope.46.2 Requirements.46.2.1 Toric IOLs for the correction of aphakia.46.2.2 Toric IOLs for the modification of the refractive power of the phakic eye47 Biocompatibility req

11、uirements47.1 Scope.47.2 General guidelines.47.3 Biological test requirements.57.4 Physicochemical test requirements.58 Sterility/package integrity requirements.58.1 Scope.58.2 Requirements.58.2.1 Toric IOLs for the correction of aphakia.68.2.2 Toric IOLs for the modification of the refractive power

12、 of the phakic eye.69 Shelf-life and transport stability69.1 Scope.69.2 Requirements.69.2.1 Toric IOLs for the correction of aphakia.69.2.2 Toric IOLs for the modification of the refractive power of the phakic eye.6iiPage10 Clinical investigation plan610.1 Scope.610.2 Requirements610.2.1 Toric IOLs

13、for the correction of aphakia.610.2.2 Toric IOLs for the modification of the refractive power of the phakic eye.610.3 Safety and efffectiveness requirements.711 Labeling.711.1 Scope.711.2 Requirements711.2.1 Labeling of spherical power.711.2.2 Labeling of cylindrical power711.3 Additional requiremen

14、ts.711.3.1 Additional requirements for toric IOLs for the corrections of aphakia711.3.2 Additional requirements for toric IOLs for the modification of the refractive power of the phakic eye7Table 1 Nominal and cylindrical dioptic power tolerances3AnnexesA Dioptric power and image quality assessment8

15、B Guidance on additional clinical requirements for toric IOLs.9C Wavefront sensor test methods for toric IOL dioptric power and image quality measurement17D Bibliography.30iiiForeword (This foreword is not part of American National Standard ANSI Z80.30-2010.)In 1985, the Z80 committee became an ANSI

16、 accredited standards committee. Thescope of the Z80 committee is the development of standards for the field of ophthal-mic optics.The Z80.30 standard deals with toric intraocular lenses used to correct for astigma-tism in either phakic or aphakic eyes. The Z80.30 committee originated from theZ80.7

17、committee on intraocular lenses. Intraocular lenses have become the mostcommon functional prosthetic implanted in the world today. Reproducibility is suchthat these lenses are no longer meant just restore basic visual function but are ex-pected to achieve excellent visual function. The Z80.30 standa

18、rd addresses the addi-tional requirements for a new generation of intraocular lenses that correct for pre-existing and surgically induced astigmatism. Unlike the Z80.7 standard, the Z80.30toric standard is for both aphakic and phakic lenses. This standard contains four annexes. Annex A is normative

19、and is considered part ofthis standard. Annexes B, C, and D are informative and are not considered part ofthis standard.Suggestions for improvement of this standard will be welcome. They should be sentto: The Vision Council, 1700 Diagonal Road, Suite 500, Alexandria, VA 22033This standard was proces

20、sed and approved for submittal to ANSI by the AccreditedStandards Committee on Ophthalmic Standards, Z80. Committee approval of thisstandard does not necessarily imply that all committee members voted for its approv-al. At the time it approved this standard, the Z80 Committee had the following mem-b

21、ers:Thomas C. White, ChairpersonQuido Cappelli, Vice-ChairpersonRobert Rosenberg, SecretaryKen Wood, SecretariatOrganization Represented Name of RepresentativeAdvance Medical Technologies AssociationDouglas J. FortunatoRichard Courtney (Alt.)Glenn Davies (Alt.)Bernie Liebler (Alt.)American Acadamy o

22、f Optometry.David S. LoshinAmerican Academy of Ophthalmology.Thomas C. WhiteCarl Tubbs (Alt.)Pradeep Ramulu (Alt.)Rebecca Hyder (Alt.)American Ceramic Society.Lyle RubinHerbert Hoover (Alt.)American Glaucoma SocietySteven GeddeDouglas Rhee (Alt.)American Optometric AssociationJeffrey WeaverRobert Ro

23、senberg (Alt.)William Benjamin (Alt.)William Brown (Alt.)American Society of Cateract and Refractive Surgery.Stephen KlyceJack T. Holladay (Alt.)Contact Lens Institute.Stan RogaskiPeter Mathers (Alt.)Contact Lens Manufacturers AssociationQuido CappelliJan Svochack (Alt.)John Walfoort (Alt.)ivOrganiz

24、ation Represented Name of RepresentativeFederated Cornea Societies/ASCRS.Michael BelinDavid Glasser (Alt.)Food Purpose of the device; Device description, including location where it is placed and how it works; When the device should not be used; Risks and benefits; Warnings and precautions; Informat

25、ion to the patient about what to expect before, during and after implantation of the toric IOL; Clinical investigation results (including adverse events). 11.3.2 Additional requirements for toric IOLs for the modification of the refractive power of the phakic eye The requirement in ANSI Z80.13 shall

26、 apply. ANSI Z80.30-2010 8 Annex A (normative) Dioptric power and image quality assessment The manufacturer shall employ the methods for dioptric power and image quality assessment outlined in this annex. Alternative methods may be employed, if the manufacturer can demonstrate that toric IOLs meetin

27、g minimum requirements associated with the alternative methods, also meet the requirements of clause 5 of this standard. An example of one alternative method is provided in Annex C. A.1 Dioptric power The methods in ISO 11979-2, Annex A, shall be modified to allow measurement of the dioptric power i

28、n the meridians of highest and lowest dioptric power, and allow alignment of the measurement axis with the toric IOLs cylindrical axis reference mark; see 5.2.2 in this standard. NOTE: One example is to use a slit aperture to isolate light passing through a selected meridian. NOTE: A modified bench

29、e.g., additional converging lens, a microscope objective of appropriate numerical aperture, etc.) may be needed to quantify the image quality of negative dioptric power toric IOLs. A.2 Image quality The image quality of the toric IOL shall be evaluated by one of the two following methods: A.2.1 MTF

30、 measurement in an eye model The method in ISO 11979-2, Annex C, shall be modified to allow measurement of the MTF in the meridians of highest and lowest dioptric power. A.2.2 Resolution efficiency The optical bench described in Annex A of ISO 11979-2 shall be modified with the addition of a cylindr

31、ical lens (null lens) placed behind or in front of the toric IOL being tested. The null lens has 0.0 diopter power in one meridian and in the orthogonal meridian a dioptric power equal to the negative of the cylindrical power of the toric IOL. The combination of null lens and toric IOL creates a mon

32、ofocal system, which is inspected for image quality using the resolution efficiency method for monofocal IOLs in ISO 11979-2, Annex B. Alternatively, the null lens shall be designed as a toric lens with two dioptric powers, equal in magnitude but with opposite sign. The magnitude of the meridional p

33、owers is equal to one half the magnitude of the designed cylindrical power. When aligned properly, the combined toric IOL and null lens system creates a monofocal system with a dioptric power equal to the spherical equivalent of the designed toric IOL. Thus, the methods of ISO 11979-2 may be used to

34、 both measure the labeled spherical equivalent (ISO 11979-2, Annex A) and the resolution efficiency (ISO 11979-2, Annex B), concurrently. Alignment of the null lens cylindrical axis with the axis of the toric IOL is made with reference to a mark or some defined feature on the toric IOL body. ANSI Z8

35、0.30-2010 9 Annex B (informative) Guidance on additional clinical requirements for toric IOLs This Annex is intended to provide guidance in the development of clinical investigations of toric IOLs, and is not intended to prescribe standardized methods for clinical practice. B.1 Objectives The object

36、ives of the clinical investigation of a toric IOL are to determine its safety and performance which includes its ability to reduce astigmatism. Outlined below are the additional clinical assessments specific to the evaluation of a new toric IOL, which begin with the assessments in ISO 11979-7 for a

37、new aphakic monofocal IOL and in ANSI Z80.13 for a new phakic IOL. B.2 Effectiveness outcomes The primary effectiveness outcomes for studies of toric IOLs are: 1. Reduction of cylinder a. Percent reduction in absolute cylinder1b. Percent of eyes with “reduction of cylinder” within 0.50 D and within

38、1.00 D of intended21Percent reduction of absolute cylinder is defined as follows, at the stability time point: For aphakic toric IOLs: is the difference between the postoperative magnitude of Manifest Refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended

39、 reduction of cylinder2as defined below, expressed as a percentage. The percentage is calculated with the manifest refraction converted to the corneal plane. For phakic toric IOLs: is the difference between the postoperative magnitude of Manifest Refractive cylinder and the preoperative magnitude of

40、 Manifest Refractive cylinder divided by the intended reduction of cylinder2as defined below, expressed as a percentage. The percentage is calculated in the spectacle plane to reflect expectations of clinical outcomes, and again with the refractions converted to the corneal plane. 2Intended reductio

41、n of cylinder is defined as follows, at the stability time point: The intended outcome should take into account the effects of the corneal incision. For aphakic toric IOLs: difference between the “intended” magnitude of the postoperative Manifest Refractive cylinder and the magnitude of the preopera

42、tive keratometric cylinder. The calculations are performed with the manifest refraction converted to the corneal plane. For phakic toric IOLs: difference between the “intended” magnitude of the postoperative Manifest Refractive cylinder and the preoperative Manifest Refractive cylinder. The calculat

43、ions are performed in both the spectacle and corneal planes. ANSI Z80.30-2010 10 2. Lens axis misalignment, as determined by a direct measurement method The method should have sufficient precision (two standard deviations) to detect a five degree change in rotation. An example method is given in ref

44、erence 4 in Annex D of this standard. The method should adjust for head tilt, for example by utilizing registration to details in the iris, sclera or conjunctiva. The secondary effectiveness outcome is lens misalignment as determined by post-op manifest refraction and vector analysis B.3 Additional

45、outcomes: Visual disturbances related to toric IOL implant A questionnaire should be administered to subjects to assess for visual disturbances related to the toric IOL implant. The questionnaire should be administered at the preoperative and the 120-day to 180-day reporting periods (and/or the 330-

46、day to 420-day reporting period if the study is at least 1 year in duration). Until a validated questionnaire for eyes with toric intraocular lenses becomes available, applicable questions from validated questionnaires such as Vitale Ref 17 should be used (validated for a different population), and

47、should be supplemented to include questions related to spatial distortion related to axis misalignment, such as whether objects appear tilted or misshapen, whether the floor appears curved, and whether the patient feels queasiness related to their vision. B.4 Study group The clinical investigation s

48、hould be performed to assess the clinical performance of the range of cylindrical corrections that the manufacturer intends to make available. A minimum sample size should be achieved at all follow-up visits, to assure a reasonable size cohort. If a toric surface is being added to an approved IOL, a

49、 minimum sample size of 100 subjects is recommended to allow each investigator to have sufficient experience implanting the device, and to allow for a sufficient number of investigators to assess inter-investigator variation in outcomes (e.g., minimum of 5 investigators). The clinical assessment of both a new IOL and new toric surface may be combined in one clinical investigation, with total sample size driven by safety analysis, as outlined in ISO 11979-10 for phakic toric IOLs or ANSI Z80.7 for aphakic toric IOLs.3There should be a reasonable distributio