1、American National Standardfor Ophthalmics Accommodative Intraocular LensesANSI Z80.29-2015ANSIZ80.29-2015ANSIZ80.29-2015American National Standardfor Ophthalmics Accommodative Intraocular LensesSecretariatThe Vision CouncilApproved May 28, 2015American National Standards Institute, Inc.Approval of a
2、n 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, substantial agreement has been reached b
3、y 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 use of American National Standards i
4、s 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 Standards Institute does not develo
5、p 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 Institute. Requests for interpretations shou
6、ld 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 be taken periodically to reaffirm,
7、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 CouncilZ80 Secretariat225 Reinekers LaneAlexandria, VA 22314Copy
8、right 2015 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 Accredited Committee Z80 for Ophthalmi
9、c Standards -The Vision CouncilZ80 Secretariat225 Reinekers LaneAlexandria, VA 22314iContentsPageForeword .iv1 Scope and purpose 12 Normative references. 13 Definitions 24 Physical requirements 24.1 Scope. 24.2 Requirements. 24.2.1 Tolerances and dimensions. 35 Optical requirements 35.1 Scope. 35.2
10、Requirements. 35.2.1 Optical characterization . 35.2.2 Dioptric power 35.2.3 Imaging quality. 35.2.4 Spectral transmittance . 46 Mechanical requirements. 46.1 Scope. 46.2 Requirements. 46.2.1 Mechanical characterization 46.2.2 Mechanical Testing 47 Biocompatibility requirements 57.1 Scope. 57.2 Gene
11、ral Guidelines 57.3 Biological test requirements. 57.4 Physicochemical test requirements . 58 Sterility/package integrity requirements. 68.1 Scope. 68.2 Requirements. 69 Shelf-life and transport stability requirements 69.1 Scope. 69.2 Requirements. 610 Clinical evaluation 610.1 Scope. 610.2 Clinical
12、 investigation plan. 610.3 Effectiveness requirements 711 Labeling . 8iiPageAnnexesA Optical characterization . 9A.1 General 9A.2 Optical characterization . 9A.2.1 Theoretical evaluation 9A.2.2 Optical testing 9B Clinical investigation 10B.1 General 10B.1.1 Clinical measurements 11B.2 Objectives of
13、the clinical investigation . 11B.3 Design of the clinical investigation. 11B.3.1 Investigation duration. 12B.3.2 Enrollment of subjects . 13B.3.3 Inclusion and exclusion criteria for subject selection . 13B.3.3.1 Inclusion criteria. 13B.3.3.2 Exclusion criteria 13B.3.4 Examination schedule 14B.4 Cli
14、nical tests. 17B.4.1 Visual acuity and manifest refraction . 17B.4.1.1 Minimum near add procedure at 40 cm . 18B.4.1.2 Luminance . 19B.4.1.3 Data recording procedures 19B.4.2 Specular Microscopy . 19B.4.3 Contrast sensitivity. 19B.4.4 Pupil size . 20B.4.5 Slit lamp exam . 20B.4.6 Measurement of intr
15、aocular pressure 21B.4.7 Subject questionnaire 21B.4.8 Accommodation measures 21B.4.8.1 Objective accommodation measures. 21B.4.8.1.1 Objective optical/refractive methods 22B.4.8.1.1.1 Autorefractors 22B.4.8.1.1.2 Wavefront aberrometry 22B.4.8.1.2 Objective biometric methods . 22B.4.8.2 Subjective a
16、ccommodation measures . 24B.4.8.2.1 Defocus curves 24B.4.8.2.2 Push-down test 25B.4.9 Reading ability test 26B.5 Investigation analyses . 27iiiPageB.5.1 Safety analyses 27B.5.2 Effectiveness analyses. 27B.5.3 Accountability analyses 29B.5.4 Stability analyses . 30B.5.4.1 Objective accommodative stab
17、ility . 30B.5.4.2 Manifest refraction spherical equivalent (MRSE) stability 31B.6 Adverse events and adverse device effects. 31C Labeling for AIOLs . 32C.1 Scope . 32C.2 Information to be found on the outer container 32C.3 Labeling for inner container and/or pouch 32C.4 Physician package insert . 32
18、C.5 Patient labeling. 33D Determination of sample sizes for the clinical investigation . 34D.1 Statistical symbols and definitions . 34D.2 Calculation of necessary sample sizes 35D.2.1 Sample size of the AIOL arm, based on safety considerations 35D.2.2 Sample size for the primary effectiveness endpo
19、int. 35D.2.3 Sample size based on effectiveness estimates using noninferiority hypothesis testing 36D.3 Substudies . 36D.3.1 Sample size for a contrast sensitivity substudy 36E Bibliography . 37TablesB.1 Minimum sample size (subjects) for evaluation . 12B.2 Recommended postoperative examination sche
20、dule 15B.3 Accountability at each post-operative visit . 29D.1 Symbol definitions 34D.2 Normal quantities to use in equations 35ivForeword (This foreword is not part of American National Standard ANSI Z80.29-2015.)This standard contains five annexes. Annex A is normative and is considered part ofthe
21、 standard. Annexes B through E are informative and are not considered part of thestandard.Suggestions for improvement of this standard are welcome. They should be sent tothe Vision Council, 225 Reinekers Lane, Suite 700, Alexandria, VA 22314.This standard was processed and approved for submittal to
22、ANSI by the AccreditedStandards Committee on Ophthalmic Optics, Z80. Committee approval of this stan-dard indicates general consensus but in no way implies that all committee membersvoted for approval. At the time it approved this standard, the Z80 Committee had thefollowing members:Thomas C. White,
23、 M.D., ChairmanQuido Cappelli, Vice-Chairman William Benjamin, O.D., SecretaryJeff Endres, Secretariat Z80Organization Represented Name of RepresentativeAbbot Medical Optics . Leonard BorrmannAdvance Medical Technologies Association Michael PfliegerAmerican Academy of Ophthalmology . Dr. Thomas Whit
24、eAmerican Academy of Optometry. Dr. David LoshinAmerican Ceramic Society . Lyle RubinAmerican Glaucoma Society Dr. Steven GeddeAmerican Optometric Association Dr. Karl CitekAmerican Society of Cataract and Refractive Ophthalmology Dr. Stephen KlyceContact Lens Institute. Stan RogaskiContact Lens Man
25、ufacturers Association. Quido CappelliDepartment of Veterans Affairs Dr. John TownsendFederated Cornea Societies/ASCRS . Dr. Michael BelinFood similar considerations apply to control group). NOTES 1) The review of data from at least 50 eyes with follow-up through the 120 180-day postoperative evalua
26、tion is recommended prior to bilateral implantation. 2) A subpopulation of at least 100 subjects with bilateral AIOL implants is recommended to allow an adequate assessment of bilateral AIOL performance. 10.3 Effectiveness requirements The effectiveness of the AIOL shall be evaluated. Annex B contai
27、ns suggested detail concerning a clinical investigation. ANSI Z80.29-2015 8 11 Labeling The requirements of ISO 11979-4 shall apply, with the following additions: a graph of the spectral transmittance through the AIOL; dioptric power; and instructions for use, including power constant and a statemen
28、t that only validated folders/ injectors shall be used. Additional recommendations are provided in Annex C.ANSI Z80.29-2015 9 Annex A (normative) Optical characterization A.1 General The manufacturer shall characterize the optical design of the AIOL as described below. A.2 Optical characterization A
29、.2.1 Theoretical evaluation The manufacturer shall measure or perform a theoretical evaluation (e.g., ray trace evaluation) of the optical design demonstrating the additional power other than the far power provided by the mechanism of action of the AIOL in the ISO eye model referenced in the current
30、 ISO11979-2. The evaluation shall include the determination of any change in the maximum near power that may occur with a change in the far power, for the range of labeled far powers. A.2.2 Optical testing The following testing shall be performed on the AIOLs: Modulation transfer function (MTF) test
31、ing: Through-frequency-response, MTF measurements are to be made with the AIOL in the eye model described in ISO 11979-2 at 546 nm 10 nm. MTF curves are to be generated in the far power configuration with a 3-mm aperture, and then at other configurations that include the clinical function of the dev
32、ice and intended claim(s) in 0.5-D increments (optical power at the corneal plane), while maintaining best focus by changing position of the sensor for the particular accommodated configuration of the AIOL. Where allowed by the AIOL design, through-focus-response MTF measurements at 50 mm-1using a 3
33、-mm aperture are to be made with the AIOL in the eye model described in ISO 11979-2 at 546 10 nm in the far power configuration. Start with maximum MTF at 50 mm-1 for an object at infinity and then measure the MTF response at positions in image space corresponding to closer object distances down to
34、20 cm in 0.25-D increments (optical power at the corneal plane). For this MTF testing, use 10 representative samples each of low, medium and high power. NOTE In each case, the performance should be compared to that of a monofocal lens. Optical power at corneal plane shall be confirmed through theore
35、tical calculations. ANSI Z80.29-2015 10 Annex B (informative) Clinical investigation B.1 General In this annex, guidance is given on the design of the clinical investigation and in analyzing the data from that investigation. The contents of this annex are listed below: B.1 General B.1.1 Clinical Ass
36、essments B.2 Objectives of Clinical Investigation B.3 Design of Clinical Investigation B.3.1 Investigation duration B.3.2 Enrollment of subjects B.3.3 Inclusion and exclusion criteria for subject selection B.3.3.1 Inclusion criteria B.3.3.2 Exclusion criteria B.3.4 Examination schedule B.4 Clinical
37、tests B.4.1 Visual acuity and Manifest Refraction B.4.1.1 Minimum Near add procedure at 40 cm B.4.1.2 Luminance B.4.1.3 Data recording procedures B.4.2 Specular microscopy B.4.3 Contrast sensitivity B.4.4 Mesopic pupil size B.4.5 Slit lamp exam B.4.6 Measurement of intraocular pressure B.4.7 Subject
38、 questionnaire B.4.8 Accommodation measures B.4.8.1 Objective accommodation measures B.4.8.1.1 Objective optical/refractive methods B.4.8.1.2 Objective biometric methods B.4.8.2 Subjective accommodation measures B.4.8.2.1 Defocus curve B.4.8.2.2 Push-down test B.4.9 Reading ability test B.5 Investig
39、ation analyses B.5.1 Safety analysis B.5.2 Effectiveness analysis B.5.3 Accountability analysis B.5.4 Stability analyses B.5.4.1 Objective Accommodative stability B.5.4.2 Manifest refraction spherical equivalent (MRSE) stability B.6 Adverse events and adverse device effects ANSI Z80.29-2015 11 B.1.1
40、 Clinical assessments All of the monofocal safety and effectiveness assessments specified in ISO 11979-7 should be performed. The following additional safety and effectiveness assessments should be performed: objective assessment of accommodation; uncorrected visual acuity at far, intermediate and n
41、ear; manifest refraction; intermediate visual acuity with best distance correction; near visual acuity with best distance correction; minimum add power (over best distance manifest correction) required to achieve best corrected near acuity; subject questionnaire; and contrast sensitivity. Additional
42、 optional assessments include: subjective assessment of accommodation (defocus, push-down, etc.); and reading ability test. B.2 Objectives of the clinical investigation The objectives of the clinical investigation are to determine the safety and effectiveness of the AIOL. The recommended primary saf
43、ety assessments and analysis are provided in ISO 11979-7. In addition to the safety analyses recommended in ISO 11979-7, the trial should characterize the rate of adverse events that may be specifically related to the design features of the accommodating lens e.g., anterior or posterior malpositioni
44、ng of the lens within the capsule or through the capsulorhexis, all secondary procedures performed to correct such malpositionings or to ensure accommodative functionality and any non-grid significant events. Effectiveness should be demonstrated by the effectiveness assessments listed in B.1.1. The
45、sample size for the study should be adequate to detect adverse events with an expected rate of 1% or greater (i.e., 300 evaluable subjects available at all scheduled visits in the AIOL group). A control group of sufficient size for comparisons of effectiveness and contrast sensitivity is also needed
46、. The statistical method recommended to make these calculations is found in Annex D, as well as examples of sample size calculations made using these methods. B.3 Design of the clinical investigation The type of clinical investigation recommended is a prospective, controlled, randomized, masked (sub
47、ject and examiner), multicenter trial. The adverse events that are common to ISO 11979-7 are compared to the safety and performance endpoints described in ISO 11979-7. The clinical trial is to be a two-phase trial with 50 AIOL subjects and 50 control subjects in Phase I and the remainder of subjects
48、 in Phase II. After demonstration of at least one diopter of mean objectively measured accommodative amplitude at 4 6 months in the Phase I AIOL subject group ANSI Z80.29-2015 12 over the control group, Phase II subjects may be enrolled. Phase II is to be comprised of both test and control subjects.
49、 Objective assessment of accommodation should be continued in Phase II on a subset of both test and control subjects with sample size determined by both statistical and clinical significance; however, a minimum of 100 AIOL subjects are to be measured (between Phase I and Phase II). Subjective assessment of accommodative amplitude is optional. The clinical investigative plan should include a description of the selection of subjects for objective measurement of accommodation sub-study and include description of the methods used to minimize potential
