SIST EN ISO 11979-10:2018
(Main)Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
This document specifies requirements for any intraocular lenses to be implanted in the anterior
segment of the eye with the primary indication to modify its refractive power.
There are three main categories of phakic intraocular lenses depending on the optical design:
a) Phakic monofocal (PIOL);
b) Phakic multifocal (PMIOL); and
c) Phakic toric (PTIOL).
Each of these categories is further designated for implantation in either the anterior or posterior
chamber of the anterior segment of the eye.
The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and
PTIOL designs.
This document addresses specific clinical requirements for phakic IOLs that are not addressed in the
other parts of ISO 11979.
Ophthalmische Implantate - Intraokularlinsen - Teil 10: Klinische Prüfungen von Intraokularlinsen zur Korrektion der Ametrophie in phaken Augen (ISO 11979-10:2018)
Dieses Dokument legt besondere Anforderungen für Intraokularlinsen fest, die zur Implantation in den Vorderabschnitt des Auges vorgesehen sind und deren primäre Indikation die Modifikation der Brechkraft eines phaken Auges ist.
Es gibt drei Hauptkategorien für phake Intraokularlinsen in Abhängigkeit des Optikdesigns:
a) Phake monofokal (PIOL)
b) Phake multifokal (PMIOL)
c) Phake torische (PTIOL)
Jede dieser Kategorien ist zur Implantation in die vordere oder hintere Augenkammer vorgesehen.
Die grundlegenden Anforderungen für phake IOL gelten für alle Typen. Zusätzliche Anforderungen gelten für die Ausführungen PMIOL und PTIOL.
Dieses Dokument legt zusätzliche Anforderungen für phake IOL fest, die nicht bereits in anderen Teilen von ISO 11979 abgedeckt werden.
Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Investigations cliniques de lentilles intraoculaires pour la correction de l'amétropie des yeux phaques (ISO 11979-10:2018)
L'ISO 11979-10:2018 spécifie des exigences s'appliquant aux lentilles intraoculaires destinées à être implantées dans le segment antérieur de l'?il, l'indication principale de cela étant de modifier sa puissance de réfraction.
Les lentilles intraoculaires phaques se répartissent en trois grandes catégories, selon leur conception optique:
a) lentilles intraoculaires phaques monofocales (LIOP);
b) lentilles intraoculaires phaques multifocales (LIOPM);
c) lentilles intraoculaires phaques toriques (LIOPT).
En outre, chacune de ces catégories est conçue pour l'implantation dans la chambre antérieure ou dans la chambre postérieure du segment antérieur de l'?il.
Les exigences de base liées aux LIO phaques s'appliquent à tous ces types. Des exigences supplémentaires s'appliquent aux conceptions LIOPM et LIOPT.
L'ISO 11979-10:2018 couvre les exigences cliniques spécifiques aux LIO phaques qui ne sont pas abordées dans les autres parties de l'ISO 11979.
Očesni vsadki (implantati) - Intraokularne leče - 10. del: Klinične preiskave intraokularnih leč za popravek ametropije pri lečah »phakic« (ISO 11979-10:2018)
Ta dokument določa zahteve za vse intraokularne leče, ki so namenjene vsaditvi v notranji
del očesa z glavnim namenom spremeniti lomnost očesa.
Obstajajo tri glavne kategorije intraokularnih leč »phakic« glede na optično zasnovo:
a) monofokalne leče »phakic« (PIOL);
b) multifokalne leče »phakic« (PMIOL); in
c) torične leče »phakic« (PTIOL).
Vsaka od teh kategorij je nadalje namenjena vsaditvi bodisi v sprednji ali zadajšnji
prekat ali notranji del očesa.
Osnovne zahteve za leče »phakic« IOL veljajo za vse vrste leč. Dodatne zahteve veljajo za zasnovi PMIOL in
PTIOL.
Ta dokument obravnava posebne klinične zahteve za leče »phakic« IOL, ki niso obravnavane v
drugih delih standarda ISO 11979.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11979-10:2018
01-september-2018
1DGRPHãþD
SIST EN ISO 11979-10:2006
SIST EN ISO 11979-10:2006/A1:2014
2þHVQLYVDGNL LPSODQWDWL ,QWUDRNXODUQHOHþHGHO .OLQLþQHSUHLVNDYH
LQWUDRNXODUQLKOHþ]DSRSUDYHNDPHWURSLMHSULOHþDKªSKDNLF© ,62
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular
lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
Ophthalmische Implantate - Intraokularlinsen - Teil 10: Klinische Prüfungen von
Intraokularlinsen zur Korrektion der Ametrophie in phaken Augen (ISO 11979-10:2018)
Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Investigations cliniques de
lentilles intraoculaires pour la correction de l'amétropie des yeux phaques (ISO 11979-
10:2018)
Ta slovenski standard je istoveten z: EN ISO 11979-10:2018
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-10:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11979-10:2018
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SIST EN ISO 11979-10:2018
EN ISO 11979-10
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11979-10:2006
English Version
Ophthalmic implants - Intraocular lenses - Part 10: Clinical
investigations of intraocular lenses for correction of
ametropia in phakic eyes (ISO 11979-10:2018)
Implants ophtalmiques - Lentilles intraoculaires - Ophthalmische Implantate - Intraokularlinsen - Teil 10:
Partie 10: Investigations cliniques de lentilles Klinische Prüfungen von Intraokularlinsen zur
intraoculaires pour la correction de l'amétropie des Korrektion der Ametrophie in phaken Augen (ISO
yeux phaques (ISO 11979-10:2018) 11979-10:2018)
This European Standard was approved by CEN on 28 February 2018.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-10:2018 E
worldwide for CEN national Members.
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SIST EN ISO 11979-10:2018
EN ISO 11979-10:2018 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11979-10:2018
EN ISO 11979-10:2018 (E)
European foreword
This document (EN ISO 11979-10:2018) has been prepared by Technical Committee ISO/TC 172
"Optics and photonics" in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2018, and conflicting national standards
shall be withdrawn at the latest by November 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11979-10:2006.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11979-10:2018 has been approved by CEN as EN ISO 11979-10:2018 without any
modification.
3
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SIST EN ISO 11979-10:2018
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SIST EN ISO 11979-10:2018
INTERNATIONAL ISO
STANDARD 11979-10
Second edition
2018-03
Ophthalmic implants — Intraocular
lenses —
Part 10:
Clinical investigations of intraocular
lenses for correction of ametropia in
phakic eyes
Implants ophtalmiques — Lentilles intraoculaires —
Partie 10: Investigations cliniques de lentilles intraoculaires pour la
correction de l'amétropie des yeux phaques
Reference number
ISO 11979-10:2018(E)
©
ISO 2018
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SIST EN ISO 11979-10:2018
ISO 11979-10:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 11979-10:2018
ISO 11979-10:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 2
3.1 Terms and definitions . 2
3.2 Abbreviated terms . 2
4 Optical requirements . 2
5 Mechanical requirements . 2
6 Biocompatibility requirements . 2
7 Shelf-life and transport stability requirements . 2
8 Fundamental requirements . 2
9 Justification for a clinical investigation . 3
10 General clinical requirements . 3
10.1 General . 3
10.2 Design of a clinical investigation . 3
10.2.1 Requirements for all types of phakic IOLs . 3
10.2.2 Additional requirements for PTIOLs . 3
10.2.3 Additional requirements for PMIOLs . 4
10.3 Characteristics . 4
10.3.1 General. 4
10.3.2 Characteristics applying to the clinical evaluations for all types of phakic IOLs . 4
10.3.3 Additional characteristics applying to PTIOLs . 5
10.3.4 Additional characteristics applying to PMIOLs . 5
10.4 Duration of the investigation . 5
10.5 Enrolment . 5
10.6 Bilateral implantation . 5
10.7 Surgical technique . 6
10.8 Examination and treatment of subjects. 6
10.9 Adverse events reports . 6
10.10 Inclusion and exclusion criteria . 6
10.10.1 General criteria for all phakic IOLs . 6
10.10.2 Additional criteria for PTIOLs . 9
10.10.3 Additional criteria for multifocal IOLs . 9
11 Information supplied by the manufacturer . 9
Annex A (informative) Elements in a phakic IOL clinical investigation .10
Annex B (informative) Statistical methods and sample size calculations .16
Bibliography .17
© ISO 2018 – All rights reserved iii
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SIST EN ISO 11979-10:2018
ISO 11979-10:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 11979-10:2006) and its amendment
(ISO 11979-10:2006/Amd 1:2014), which has been technically revised.
The main changes compared to the previous edition are as follows.
— modified the scope to include phakic multifocal and phakic toric intraocular lenses;
— added references to the requirements in ISO 11979-6, ISO 11979-7, and ISO 11979-8;
— modified the clinical requirements to include those for phakic multifocal and phakic toric intraocular
lenses; and
— modified the informative Annex A to include elements associated with the clinical investigation of
phakic multifocal and phakic toric intraocular lenses.
A list of all parts in the ISO 11979 series can be found on the ISO website.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 11979-10:2018
ISO 11979-10:2018(E)
Introduction
Phakic intraocular lenses are used to correct refractive errors in patients with a non-cataractous
crystalline lens. They are typically used for patients with higher amounts of myopia or hyperopia.
Originally, they contained a spherical monofocal optic to correct spherical errors but later variations
utilized a toric optic to also correct refractive astigmatism. Phakic intraocular lenses with a multifocal
optic can be used to correct presbyopia in patients that have lost the ability to accommodate.
The requirements and recommendations in the ISO series of standards for aphakic intraocular lenses for
the most part also apply to phakic intraocular lenses. Those standards should be reviewed for guidance
that would also be applicable to phakic intraocular lenses (e.g. shelf-life testing, biocompatibility
testing, etc.).
This document provides requirements and recommendations for phakic intraocular lens investigations
of new models. Risk analysis should be used to determine the investigational design, if needed, for
models that are modifications of parent phakic models. For modifications of a parent phakic model
refer to ISO/TR 22979.
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SIST EN ISO 11979-10:2018
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SIST EN ISO 11979-10:2018
INTERNATIONAL STANDARD ISO 11979-10:2018(E)
Ophthalmic implants — Intraocular lenses —
Part 10:
Clinical investigations of intraocular lenses for correction
of ametropia in phakic eyes
1 Scope
This document specifies requirements for any intraocular lenses to be implanted in the anterior
segment of the eye with the primary indication to modify its refractive power.
There are three main categories of phakic intraocular lenses depending on the optical design:
a) Phakic monofocal (PIOL);
b) Phakic multifocal (PMIOL); and
c) Phakic toric (PTIOL).
Each of these categories is further designated for implantation in either the anterior or posterior
chamber of the anterior segment of the eye.
The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and
PTIOL designs.
This document addresses specific clinical requirements for phakic IOLs that are not addressed in the
other parts of ISO 11979.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11979-1, Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary
ISO 11979-2, Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
ISO 11979-3, Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO 11979-4, Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
ISO 11979-5, Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility
ISO 11979-6, Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing
ISO 11979-7, Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of lenses for the
correction of aphakia
ISO 11979-8, Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
© ISO 2018 – All rights reserved 1
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SIST EN ISO 11979-10:2018
ISO 11979-10:2018(E)
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document the terms and definitions given in ISO 11979-1 and ISO 14155 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp
3.2 Abbreviated terms
UDVA uncorrected distance visual acuity
UIVA uncorrected intermediate visual acuity
UNVA uncorrected near visual acuity
CDVA corrected distance visual acuity
CIVA corrected intermediate visual acuity
CNVA corrected near visual acuity
DCIVA distance corrected intermediate visual acuity
DCNVA distance corrected near visual acuity
4 Optical requirements
The applicable requirements of ISO 11979-2 shall apply.
5 Mechanical requirements
The applicable requirements of ISO 11979-3 shall apply.
6 Biocompatibility requirements
The applicable requirements of ISO 11979-5 shall apply.
7 Shelf-life and transport stability requirements
The requirements of ISO 11979-6 shall apply.
8 Fundamental requirements
The requirements of ISO 11979-8 shall apply.
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SIST EN ISO 11979-10:2018
ISO 11979-10:2018(E)
9 Justification for a clinical investigation
A risk analysis shall be implemented in accordance with ISO 14971. If the risk analysis identifies the
need for a clinical investigation, the requirements of ISO 14155 shall apply, with additional requirements
given in this document.
If a new phakic IOL model is a modification of a parent phakic IOL for which the safety and performance
have already been established through clinical investigation in accordance with this document, then
[1]
a limited or no additional clinical investigation can suffice. ISO/TR 22979 provides guidance in
determining the need for a clinical investigation.
10 General clinical requirements
10.1 General
The requirements for a clinical investigation given in ISO 14155 shall apply, with additional requirements
given below.
10.2 Design of a clinical investigation
10.2.1 Requirements for all types of phakic IOLs
A non-controlled clinical investigation shall be designed to investigate the safety and performance of
PIOL designs, and PTIOL designs of higher cylinder power.
A controlled clinical investigation shall be designed to investigate the safety and performance of PMIOL
designs, and PTIOL designs of lower cylinder power (i.e. cylinder powers of 1,5 D or less).
The primary safety endpoint for all phakic IOL investigations is endothelial cell density.
NOTE In the case of the non-controlled clinical investigations, data describing changes in endothelial cell
density over time for levels of ametropia similar to the levels for the subjects in the investigation from either
literature or from a sub-study of non-operated eyes will be useful in assessing the significance of the endothelial
cell density changes in the study subjects.
10.2.2 Additional requirements for PTIOLs
During the clinical investigation of a PTIOL, the rotational stability shall be demonstrated.
The following performance criteria for rotational stability shall be fulfilled:
The IOL rotation is defined as the difference in postoperative orientation of the meridian defined by the
IOL axis indicator between that intended on the day of surgery and that measured at the final reporting
period for the investigation. Absolute rotation shall be less than 10° in 90 % of the cases, and less than
20° in 95 % of the cases.
The clinical performance of low cylinder power PTIOLs shall be demonstrated compared to the non-
toric control PIOL.
In such a clinical investigation, subjects that undergo secondary surgery to correct postoperative
phakic IOL rotational misalignment shall have their clinical results prior to the secondary surgery
carried forward as the final results for that subject, and examinations scheduled to be performed later
in the clinical investigation be performed prior to the secondary surgery, if possible.
The TIOL clinical design provisions in ISO 11979-7 shall be used to determine the additional evaluations
needed to be incorporated into the general phakic clinical investigational design described in Annex A
to evaluate the performance of the PTIOL design.
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SIST EN ISO 11979-10:2018
ISO 11979-10:2018(E)
10.2.3 Additional requirements for PMIOLs
For PMIOL designs, a clinical investigation shall evaluate the safety and performance of vision at far
distance and near distances, and at any intended intermediate focal distances. The MIOL clinical design
recommendations in ISO 11979-7 shall be used to determine the additional evaluations needed to be
incorporated into the general phakic IOL clinical investigation design described in Annex A to evaluate
the visual performance of the PMIOL design.
In all cases, the clinical investigation plan shall include defocus evaluation.
10.3 Characteristics
10.3.1 General
The clinical investigational plan shall provide information regarding characteristics to be studied, and
instructions regarding the grading and documentation of these characteristics. Whenever possible,
objective methods, such as photographic imaging, shall be used.
The following characteristics shall be considered. If additional claims are to be made, additional
corresponding characteristics shall be studied.
If several types of phakic IOLs are combined, the characteristics of all of them shall be considered.
10.3.2 Characteristics applying to the clinical evaluations for all types of phakic IOLs
a) UDVA;
b) CDVA;
c) subjective refraction;
d) contrast sensitivity;
e) pupil size;
f) intraocular pressure;
g) corneal status, including endothelial cell density status;
i) signs of inflammation:
— anterior chamber cells;
— anterior chamber flare;
— cystoid macular oedema;
— hypopyon;
— endophthalmitis;
j) pupillary block;
k) retinal detachment;
l) status of anterior and posterior capsule;
m) status of the crystalline lens;
n) status of anterior chamber angle;
o) status of iris;
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SIST EN ISO 11979-10:2018
ISO 11979-10:2018(E)
p) anterior chamber depth;
q) IOL decentration;
r) IOL tilt;
s) IOL discoloration; and
t) IOL opacity.
If justified by the risk analysis, cycloplegic refraction shall be considered for all phakic IOL investigations.
10.3.3 Additional characteristics applying to PTIOLs
a) keratometry; and
b) IOL axis mark rotation.
10.3.4 Additional characteristics applying to PMIOLs
a) UNVA, and if applicable UIVA;
b) DCNVA, and if applicable DCIVA;
c) subject questionnaire;
d) defocus evaluation; and
e) fundus visualization.
10.4 Duration of the investigation
The minimum duration of the clinical investigations shall be 3 years (see Annex A for visit window
tolerances) for all parent phakic IOLs which are not modifications of a model for which safety and
performance data have been established through clinical investigation.
When a phakic IOL is a modification of a parent phakic IOL, ISO/TR 22979 is used as guidance to
determine the need for a clinical investigation.
All subjects in a clinical investigation that have not been discontinued shall complete all visits of the
investigation. The clinical investigation shall be considered completed when all subjects that have been
enrolled in the investigation, including subjects whose phakic IOL was removed or replaced, have either
completed follow-up according to the protocol or have past the final visit window.
10.5 Enrolment
To minimize the risks associated with the clinical investigation of a new phakic IOL, subject enrolment
shall occur in stages. The subject data from each stage shall be evaluated and found acceptable by the
sponsor and the coordinating investigator (and by the regulatory body, where applicable) prior to the
continuation of the clinical investigation. Guidance on phased enrolment is included in Annex A.
10.6 Bilateral implantation
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,
evaluated and confirmed by the sponsor and coordinating investigator (and by risk analysis, if
applicable).
When implantation of fellow eyes is permitted, the clinical investigation plan shall specify the time
period between implantation of first eye and fellow eye, based upon risk analysis.
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SIST EN ISO 11979-10:2018
ISO 11979-10:2018(E)
Both the first and second eye of each subject shall be included in the analyses of endothelial cell loss,
adjusted for the correlation between eyes. The primary statistical analyses of other adverse events
shall be performed using only using the first implanted eye for each subject; secondary analyses shall
include all implanted eyes. For performance endpoints, the primary analyses shall be performed using
only the first implanted eye for each subject.
The review of data from at least 50 eyes with
...
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