ANSI Z80.30-2018 Ophthalmics C Toric Intraocular Lenses.pdf

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1、American National Standardfor Ophthalmics Toric Intraocular LensesANSI Z80.30-2018ANSIZ80.30-2018ANSIZ80.30-2018Revision ofANSI Z80.30-2010American National Standardfor Ophthalmics Toric Intraocular LensesSecretariatThe Vision CouncilApproved April 24, 2018Published June 18, 2018American National St

2、andards Institute, Inc.Approval of an American National 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, subs

3、tantial agreement has been reached by directly andmaterially 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

4、use of American National Standards is completely voluntary; 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

5、 Standards Institute does not develop standards andwill 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 Institut

6、e. Requests for interpretations should beaddressed 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

7、 be taken periodically to reaffirm, revise, orwithdraw 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 Council225 Reinekers LaneSui

8、te 700Alexandria, VA 22314Copyright 2018 by 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 Accredit

9、ed Committee Z80 for Ophthalmic Standards -The Vision CouncilZ80 Secretariat225 Reinekers LaneSuite 700Alexandria, VA 22314iContentsPageForeword .iii1 Scope and purpose 12 Normative references. 13 Definitions 24 Physical requirements 24.1 Scope. 24.2 Requirements. 24.2.1 Tolerances and dimensions. 2

10、5 Optical requirements 35.1 Scope. 35.2 Requirements. 35.2.1 Dioptric power 35.2.2 Axis orientation mark(s) . 35.2.3 Imaging quality. 35.2.4 Spectral transmittance . 36 Mechanical requirements. 36.1 Scope. 36.2 Requirements. 46.2.1 Toric IOLs for the corrections of aphakia. 46.2.2 Toric IOLs for the

11、 modification of the refractive powerof the phakic eye 47 Biocompatiblity requirements. 47.1 Scope. 47.2 General guidelines. 47.3 Biological test requirements. 47.4 Physicochemical test requirements . 58 Sterility/package integrity requirements. 58.1 Scope. 58.2 Requirements. 58.2.1 Toric IOLs for t

12、he correction of aphakia. 58.2.2 Toric IOLs for the modification of the refractive power of the phakic eye 59 Shelf-life and transport stability 59.1 Scope. 59.2 Requirements. 69.2.1 Toric IOLs for the correction of aphakia. 69.2.2 Toric IOLs for the modification of the refractive powerof the phakic

13、 eye 6iiPage10 Clinical investigation plan 610.1 Scope. 610.2 Requirements 610.2.1 Toric IOLs for the correction of aphakia. 610.2.2 Toric IOLs for the modification of the refractive powerof the phakic eye 610.3 Safety and effectiveness requirements 711 Labeling . 711.1 Scope. 711.2 Requirements 711

14、.2.1 Labeling of spherical power . 711.2.2 Labeling of cylindrical power 711.3 Additional requirements . 711.3.1 Additional requirements for toric IOLs for the correctionsof aphakia 711.3.2 Additional requirements for toric IOLs for the modification ofthe refractive power of the phakic eye . 7Annexe

15、sA Dioptric power and image quality assessment 8B Guidance on additional clinical requirements for toric IOLs. 9C Wavefront sensor test methods for toric IOL dioptric powerand image quality measurement 16D Bibliography . 29iiiForeword (This foreword is not part of American National Standard ANSI Z80

16、.30-2018.)In 1985, the Z80 committee became an ANSI 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 e

17、yes. The Z80.30 committee originated from theZ80.7 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 a

18、chieve excellent visual function. The Z80.30 standard 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 st

19、andard contains four annexes. Annex A is normative 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, 225 Reinekers Lane, Suit

20、e 700, Alexandria, VA 22034.This standard was processed 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

21、 standard, the Z80 Committee had the following mem-bers:Thomas C. White, ChairpersonNeil Roche, Vice-ChairmanWilliam J. Benjamin, O.D., SecretaryMichael Vitale, SecretariatOrganization Represented Name of RepresentativeAdvanced Medical Technology Association . Michael PflegerAmerican Academy of Opht

22、halmology . Thomas WhiteAmerican Academy of Optometry. David LoshinAmerican Ceramic Society . Lyle RubinAmerican Glaucoma Society Steven GeddeAmerican Optometric Association Karl CitekAmerican Society of Cataract and Refractive Surgery . Stephen KlyceContact Lens Institute. Stan RogaskiContact Lens

23、Manufacturers Association . Martin DaisingCornea Society . Michael BelinDepartment of Veterans Affairs John TownsendFood 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

24、; Information 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 Z8

25、0.13 shall apply. ANSI Z80.30-2018 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 I

26、OLs meeting 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 dioptr

27、ic power in 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 modif

28、ied bench (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:

29、 A.2.1 MTF 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

30、 a cylindrical 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 cre

31、ates a monofocal 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 me

32、ridional powers 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

33、be used to 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 bod

34、y. ANSI Z80.30-2018 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

35、The objectives 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 general clinical assess

36、ments in ISO 11979-7 for a new aphakic monofocal IOL and in ANSI Z80.13 for a new phakic IOL. These clinical assessments should demonstrate the rotational stability of the toric IOL and the effectiveness of the lowest cylinder power available for this toric IOL to reduce astigmatism compared to a no

37、n-toric control IOL. B.2 Investigational design A risk assessment should be performed to assess the potential for the toric IOL to rotate after implantation. If this assessment concludes that rotation of the toric IOL greater than criteria required in 10.2 is possible, a rotational predictability in

38、vestigation of the non-toric analog of the toric IOL should be performed as described in ISO 11979-7. Only if this clinical investigation determines that the non-toric analog of the toric IOL meets the rotational performance criteria required in ISO 11979-7 should the clinical investigation of the t

39、oric IOL be performed. The clinical requirements for the toric IOL differ depending on whether or not the toric IOL has a parent IOL (that has been qualified by a full 300-subject clinical investigation) from which the toric IOL has been modified. The clinical requirements for a parent IOL that has

40、been qualified by having successfully completed a clinical investigation of at least 300 subjects followed for 1 year is described in ANSI Z80.7 for aphakic IOLs, and followed for 3 years is described in ANSI Z80.13 for phakic IOLs. If the toric IOL is not a modification of a parent IOL, a phased, c

41、ontrolled, and randomized clinical investigation shall be performed on a total of 300 subjects (available at Form 4). The toric IOL investigation shall include assessments of any axis misalignment from intended position for the toric IOL, the stability of the toric IOL axis, the effectiveness of the

42、 lowest toric IOL cylinder power to reduce astigmatism compared to the control IOL of an identical design (non-toric IOL version of the toric IOL) and the basic safety and effectiveness of the IOL material and design. 1. In phase 1 (for an aphakic IOL), a total of 100 subjects with toric and control

43、 IOLs of an identical design (non-toric IOL but having toric orientation marks) should be implanted using a 2:1 (toric:control) randomization ratio and followed to Form 4. An axis mark may be added to the control IOL to better assess axis misalignment from the intended placement position and the sta

44、bility of the toric IOL at the end of Phase 1. For a phakic IOL, phase 1 should be limited to 10 subjects followed to month 6. ANSI Z80.30-2018 10 2. In phase 2 (for an aphakic IOL), all remaining subjects should be implanted using the same 2:1 ratio of toric IOLs to control IOLs, and all subjects f

45、ollowed for a minimum of one year. (For a phakic IOL, an additional 100 subjects may be implanted using the same 2:1 ratio followed to month 6.) 3. In phase 3 (for a phakic IOL), all remaining subjects should be enrolled. All subjects should be followed to 3 years postoperatively. The data from each

46、 stage is evaluated and found acceptable prior to proceeding to the next stage. Any plans for fellow eye implantation shall be described in the clinical investigation plan. Bilateral implantation shall not be implemented until initial safety and performance data have been collected and evaluated. In

47、 addition, the subject and the examiner performing all vision testing, axis misalignment from intended assessment, stability of the toric IOL axis assessment and manifest refraction should be masked to the type of IOL implanted. If the toric IOL is a modification of a parent IOL, a Level B study wit

48、h an enrolled sample size of approximately 115 toric IOL subjects and 115 control IOL subjects with the goal of at least 100 unilaterally implanted subjects in each group with all the necessary follow-up visits to Form 4 should be performed. A controlled, randomized investigation should be performed

49、. This should evaluate effectiveness with regard to the IOL axis misalignment from intended orientation (toric IOL arm only), the stability of the toric IOL axis orientation (toric IOL arm only), and the effectiveness of the lowest toric IOL cylinder power to reduce manifest astigmatism compared to the control IOL. The study should also evaluate safety (including rates of necessary secondary surgical interventions, such as those requiring IOL rotations for misalignment). In addition, the subjects and the examiners conducting all vision testing, axis orientation measu