EN ISO 11980:1997
(Main)Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:1997)
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:1997)
Specification of a uniform procedure for clinical trials.
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Leitfaden für die klinische Prüfung (ISO 11980:1997)
Diese Internationale Norm legt einen Leitfaden für die klinische Prüfung der Sicherheit und Leistungsfähigkeit von Kontaktlinsen und Kontaktlinsenpflegemitteln fest.
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Lignes directrices pour les investigations cliniques (ISO 11980:1997)
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Navodilo za klinične raziskave (ISO 11980:1997)
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Leitfaden für die klinische Prüfung (ISO 11980:1997)Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Lignes directrices pour les investigations cliniques (ISO 11980:1997)Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:1997)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 11980:1997SIST EN ISO 11980:2000en01-januar-2000SIST EN ISO 11980:2000SLOVENSKI
STANDARD
SIST EN ISO 11980:2000
SIST EN ISO 11980:2000
SIST EN ISO 11980:2000
SIST EN ISO 11980:2000
SIST EN ISO 11980:2000
AReference numberISO 11980:1997(E)INTERNATIONALSTANDARDISO11980First edition1997-12-15Ophthalmic optics — Contact lenses andcontact lens care products — Guidance forclinical investigationsOptique ophtalmique — Lentilles de contact et produits d'entretien pourlentilles de contact — Lignes directrices pour les investigations cliniquesSIST EN ISO 11980:2000
ISO 11980:1997(E)©
ISO 1997All rights reserved. Unless otherwise specified, no part of this publication may be reproducedor utilized in any form or by any means, electronic or mechanical, including photocopying andmicrofilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 · CH-1211 Genève 20 · SwitzerlandInternetcentral@iso.chX.400c=ch; a=400net; p=iso; o=isocs; s=centralPrinted in SwitzerlandiiForewordISO (the International Organization for Standardization) is a worldwidefederation of national standards bodies (ISO member bodies).
The work ofpreparing International Standards is normally carried out through ISOtechnical committees.
Each member body interested in a subject for whicha technical committee has been established has the right to be representedon that committee.
International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work.
ISOcollaborates closely with the International Electrotechnical Commission(IEC) on all matters of electrotechnical standardization.Draft International Standards adopted by the technical committees arecirculated to the member bodies for voting.
Publication as an InternationalStandard requires approval by at least 75% of the member bodies castinga vote.International Standard ISO 11980 was prepared by Technical CommitteeISO/TC 172, Optics and optical instruments, Subcommittee SC 7,Ophthalmic optics and instruments.Annexes A to D of this International Standard are for information only.SIST EN ISO 11980:2000
© ISOISO 11980:1997(E)iiiIntroductionCurrently contact lenses and contact lens care products are regulated indifferent ways in different countries. This International Standard has beendeveloped to encourage a global harmonization. It is hoped that theadoption of this International Standard will be yet another step towardMutual Recognition. This International Standard could also be used as abasis to fulfil design elements of ISO 9001.SIST EN ISO 11980:2000
SIST EN ISO 11980:2000
INTERNATIONAL STANDARD
© ISOISO 11980:1997(E)1Ophthalmic optics — Contact lenses and contact lens careproducts — Guidance for clinical investigations1
ScopeThis International Standard provides guidance for the clinical investigation of the safety and performance of contactlenses and contact lens care products.2
Normative referencesThe following standards contain provisions which, through reference in this text, constitute provisions of thisInternational Standard. At the time of publication, the editions indicated were valid. All standards are subject torevision, and parties to agreements based on this International Standard, are encouraged to investigate thepossibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintainregisters of currently valid International Standards.ISO 14155:1996 Clinical investigation of medical devicesISO 14534:1997, Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirementsNOTE
This International Standard attempts to harmonize the recognized regulatory requirements for the generation of clinicaldata to meet the marketing requirements for contact lenses and contact lens care products around the world. However, nationalrequirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takesprecedence over this International Standard.Some examples of additional requirements /guidance documents are found in annex D.3
DefinitionsFor the purposes of this International Standard, the definitions given in ISO 14155 and ISO 14534 apply.NOTE
Additional definitions can be found in ISO 8320-1 and ISO 8320-2 (see annex D).4
General clinical investigational requirementsGeneral requirements and guidance for a clinical investigation are given in ISO 14155.The clinical investigator shall inform the sponsor, the monitor and national regulatory authorities, if applicable, aboutany severe adverse event and about all adverse device effects in a timely manner (ISO 14155).SIST EN ISO 11980:2000
ISO 11980:1997(E)© ISO2The presence of severe adverse events requiring an immediate report are those that are considered sight-threatening or that may cause permanent tissue damage. These may include, but are not limited to, the following:—
corneal ulceration;—
corneal or conjunctival infection;—
severe inflammation (conjunctivitis, iritis);—
corneal scarring;—
permanent loss of vision.All recorded adverse device effects shall be included in the final report.5
Clinical investigational methodology5.1
General requirements and guidance for documentation, access to information, additional health care andclinical investigation plan are given in ISO 14155.5.2
The study shall be designed in such a manner as to minimize bias. Contact lenses and contact lens careproducts evaluated shall be chosen to provide a scientifically valid assessment of safety and performance in arepresentative population of users.NOTE 1
The objective may include the simultaneous assessment of new contact lenses and new contact lens care products.In this class of investigation, safety and performance should relate to the system as a whole and not to the individualcomponents.NOTE 2
Elements of the study design, such as the number of eyes, number of subjects and the duration of the study, shouldinclude biometric considerations as a basis for this determination. The biometric planning may use information from sourcessuch as peer-reviewed scientific literature, historical data or a pilot study. (Annex D contains informative references forconsideration in clinical studies designed for contact lenses and contact lens care products.)5.3
Steps for assessing the compliance of contact lens wearers with the requirements of the clinical investigationplan shall be included in the plan.5.4
The clinical assessment of safety and performance of a contact lens or contact lens care product shall bebased on valid scientific evidence that may include objective measurements and observations, and subjectiveresponses obtained from a clinical investigation of the device for its intended purpose.NOTE
Procedures for obtaining clinical data using objective measurements and observations, and subjective responses fromsubjects participating in a clinical investigation of a contact lens or contact lens care product are given in annexes A and B.6
Presentation of resultsA final report of the clinical investigation shall be recorded. The report shall include a copy of the clinicalinvestigation plan, data collection, data analysis together with a critical assessment of risks signed by the sponsor,and appropriate statistical analysis. The assessment of risks and benefits for signs, symptoms, problems andcomplaints shall be judged against valid scientific evidence from a concurrent control or from historical data,including the scientific literature.The final report shall include:a)accountability for all data from each centre and for all enrolled subjects, including those that have completed,were discontinued or remain active in the study at the time of the report. No subject shall be identifiable, eitherfrom the final report or published results;b)discontinued subjects and reasons for discontinuations, given in separate tables;SIST EN ISO 11980:2000
© ISOISO 11980:1997(E)3c)accountability and reasons for the number of unscheduled lens replacements;d)a list of subjects by the most recent lens-wearing experience and demographics before their enrolment in theclinical investigation;e)a list of the average lens wear time for all subjects in the study;f)a critical evaluation of all the data collected during the clinical investigation.NOTE
For sample reporting tables for the final report, see annex C.SIST EN ISO 11980:2000
ISO 11980:1997(E)© ISO4Annex A(informative)Procedures for the evaluation of safety, physiological performanceand effect on ocular tissuesA.1
GeneralThe following classifications should be considered whenever the procedure is included in the clinical investigationplan.A.2
Corneal oedemaA.2.1
GeneralCorneal oedema should be classified separately for the epithelium and for the stroma.A.2.2
Epithelial oedemaEpithelial oedema should be classified according to the number of microcystsobserved.0 = NoneNo microcysts1 = Trace1 to 20 microcysts2 = Mild21 to 50 microcysts3 = Moderate51 to 100 microcysts4 = Severe> 100 microcysts or bullaeThe presence/absence of vacuoles or bullae should be documented, along with their numbers. The presence ofbullae should be considered as reportable grade 4 severe epithelial oedema.A.2.3
Stromal oedemaStromal oedema should be classified according to the following scale:0 = NoneNo oedema1 = TraceJust detectable corneal clouding2 = MildLight density central corneal clouding (CCC);borders distinct but visible only against pupil3 = ModerateVery distinct borders on CCC or corneal striae4 = SevereDense CCC with distinct borders with corneal striaeA.3
Corneal infiltratesCorneal infiltrates should be classified according to the following scale:0 = NoneNo infiltrates1 = Trace1 to 5 epithelial infiltrates2 = Mild6 to 8 epithelial infiltrates3 = Moderate> 8 epithelial infiltrates4 = SeverePresence of stromal infiltratesSIST EN ISO 11980:2000
© ISOISO 11980:1997(E)5A.4
Endothelial regularityEndothelial regularity should be classified according to the following scale:0 = Regular endothelial mosaic1 = Isolated difference in cell size2 = Just noticeable variation in cell size or bumpiness of cell layer3 = Easily detected difference in cell size or bumpiness of cell layer4 = Noticeable cell layer bumpiness and loss of definition of cell bordersA.5
Corneal vascularizationMaximal corneal vascularization should be reported according to the following scale:0 = NoneNo vessel penetration1 = Trace< 1,00 mm vessel penetration2 = Mild³1,00 mm to £ 1,5 mm vessel penetration3 = Moderate>1,5 mm to £ 2,00 mm
vessel penetration4 = SevereVessel penetration > 2,0 mmOptionally the depth and location of vessel penetration can also be reported as follows:Depth:a) superficialb) stromalLocation:NNasalTTemporalIInferiorSSuperiorCCircumferentialXOther (describe)A.6
Corneal staining with fluoresceineCorneal staining should be recorded according to the following scale (see notes 1 and 2 below):0 = NoneNo staining1 = TraceMinimal superficial staining or stipplinga)Dimpling, discrete dot staining, orb)Trace superficial lens insertion marks or foreign body tracks2 = MildRegional or diffuse punctate staininga)Central or generalized, orb)Peripheral including 3 - 9 o'clock staining, orc)Foreign body tracks3 = ModerateDense coalescent staining up to 2 mm in diametera)Corneal abrasionb)Foreign body tracks4 = SevereDense coalescent staining greater than 2 mm in diameterThe location of the staining observed should be recorded in the following manner. The preferred method forrecording the location is by numbers (see figure A.1).NOTE 1
— All corneal staining observations should be carried out using a blue stimulation light in conjunction with a yellowbarrier filter in the observation system.NOTE 2
— Recurrent erosion and corneal ulceration should be recorded under a section "Other complications".SIST EN ISO 11980:2000
ISO 11980:1997(E)© ISO61 orCCentre2 or SSuperior3 or NNasal4 orIInferior5 or TTemporalFigure A.1 — Example of method for recording location of stainingA.7
Conjunctival observationsLimbal hyperaemia should be recorded on a 5-point scale as follows:0 = NoneNo hyperaemia1 = TraceSlight limbal (mild segmented)2 = MildMild limbal (mild circumcorneal)3 = ModerateSignificant limbal (marked segmented)4 = SevereSevere limbal (marked circumcorneal)Bulbar conjunctival hyperaemia should be recorded on a 5-point scale as follows:0 = NoneNo hyperaemia1 = TraceSlight regional hyperaemia2 = MildDiffuse hyperaemia3 = ModerateMarked regional or diffuse hyperaemia4 = SevereDiffuse episcleral or scleral hyperaemiaBulbar conjunctival compression/indentation (0 equals absence, 1 equals presence)A.8
Palpebral conjunctival observationsThe location of maximal conjunctival response should be documented according to the following scale:0 = NoneUniform satin appearance of the conjunctiva1 = Trac
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