Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)

This document specifies the particular requirements for the clinical investigations of intraocular lenses
that are implanted in the eye in order to correct aphakia.

Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen von Intraokularlinsen für die Korrektion von Aphakie (ISO 11979-7:2018)

Dieses Dokument legt die besonderen Anforderungen an die klinische Prüfung von Intraokularlinsen (IOL) fest, die zur Korrektur von Aphakie in das Auge implantiert werden.

Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques de lentilles intraoculaires pour la correction de l'aphakie (ISO 11979-7:2018)

L'ISO 11979-7:2018 spécifie les exigences particulières applicables aux investigations cliniques de lentilles intraoculaires destinées à être implantées dans l'?il pour corriger l'aphakie.

Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave intraokularnih leč za korekcijo afakije (ISO 11979-7:2018)

Ta dokument določa posebne zahteve za klinične preiskave intraokularnih leč,
ki se vstavijo v oko za korekcijo afakije.

General Information

Status
Published
Public Enquiry End Date
04-May-2017
Publication Date
11-Jun-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-May-2018
Due Date
29-Jul-2018
Completion Date
12-Jun-2018

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SLOVENSKI STANDARD
SIST EN ISO 11979-7:2018
01-julij-2018
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SIST EN ISO 11979-7:2014
SIST EN ISO 11979-9:2006
SIST EN ISO 11979-9:2006/A1:2014
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Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular

lenses for the correction of aphakia (ISO 11979-7:2018)
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen von
Intraokularlinsen für die Korrektion von Aphakie (ISO 11979-7:2018)

Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques de

lentilles intraoculaires pour la correction de l'aphakie (ISO 11979-7:2018)
Ta slovenski standard je istoveten z: EN ISO 11979-7:2018
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-7:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-7:2018
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SIST EN ISO 11979-7:2018
EN ISO 11979-7
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11979-7:2014, EN ISO 11979-
9:2006
English Version
Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations of intraocular lenses for the correction of
aphakia (ISO 11979-7:2018)

Implants ophtalmiques - Lentilles intraoculaires - Ophthalmische Implantate - Intraokularlinsen - Teil 7:

Partie 7: Investigations cliniques de lentilles Klinische Prüfungen von Intraokularlinsen für die

intraoculaires pour la correction de l'aphakie (ISO Korrektion von Aphakie (ISO 11979-7:2018)

11979-7:2018)
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 11979-7:2018 E

worldwide for CEN national Members.
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SIST EN ISO 11979-7:2018
EN ISO 11979-7:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 11979-7:2018
EN ISO 11979-7:2018 (E)
European foreword

This document (EN ISO 11979-7:2018) 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 11979-7:2014 and EN ISO 11979-9:2006.

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 11979-7:2018 has been approved by CEN as EN ISO 11979-7:2018 without any

modification.
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SIST EN ISO 11979-7:2018
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SIST EN ISO 11979-7:2018
INTERNATIONAL ISO
STANDARD 11979-7
Fourth edition
2018-03
Ophthalmic implants — Intraocular
lenses —
Part 7:
Clinical investigations of intraocular
lenses for the correction of aphakia
Implants ophtalmiques — Lentilles intraoculaires —
Partie 7: Investigations cliniques de lentilles intraoculaires pour la
correction de l'aphakie
Reference number
ISO 11979-7:2018(E)
ISO 2018
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SIST EN ISO 11979-7:2018
ISO 11979-7:2018(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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 11979-7:2018
ISO 11979-7:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms, definitions and abbreviated terms ................................................................................................................................ 1

3.1 Terms and definitions ....................................................................................................................................................................... 1

3.2 Abbreviated terms ............................................................................................................................................................................... 1

4 Justification for a clinical investigation ........................................................................................................................................ 2

5 Ethical considerations .................................................................................................................................................................................... 2

6 General requirements ..................................................................................................................................................................................... 2

6.1 General ........................................................................................................................................................................................................... 2

6.2 Design of a clinical investigation ............................................................................................................................................. 2

6.2.1 Requirements for all types of IOLs ................................................................................................................... 2

6.2.2 Additional requirements for toric IOLs (TIOLs) ................................................................................... 3

6.2.3 Additional requirements for multifocal IOLs (MIOLs) .................................................................... 3

6.2.4 Additional requirements for accommodating IOLs (AIOLs) ...................................................... 3

6.2.5 Additional requirements for anterior chamber IOLs ....................................................................... 3

6.3 Characteristics of clinical investigations .......................................................................................................................... 4

6.3.1 General...................................................................................................................................................................................... 4

6.3.2 Characteristics to be studied for all types of IOLs ............................................................................... 4

6.3.3 Additional characteristics to be studied for TIOLs ............................................................................. 4

6.3.4 Additional characteristics to be studied for MIOLs ........................................................................... 5

6.3.5 Additional characteristics to be studied for AIOLs .................. ........................................................... 5

6.3.6 Additional characteristics applying to anterior chamber IOLs ................................................ 5

6.3.7 Additional characteristics ........................................................................................................................................ 5

6.4 Duration of the investigations ................................................................................................................................................... 5

6.5 Enrolment .................................................................................................................................................................................................... 6

6.6 Bilateral implantation ....................................................................................................................................................................... 6

6.7 Surgical technique ................................................................................................................................................................................ 6

6.8 Examination and treatment of subjects............................................................................................................................. 6

6.9 Adverse events reports .................................................................................................................................................................... 7

6.10 Inclusion and exclusion criteria ............................................................................................................................................... 7

6.10.1 General...................................................................................................................................................................................... 7

6.10.2 Additional inclusion criteria for TIOLs ......................................................................................................... 7

6.10.3 Additional exclusion criteria for MIOLs ....................................................................................................... 7

6.10.4 Additional exclusion criteria for anterior chamber IOLs .............................................................. 8

Annex A (informative) General elements in the clinical investigation of IOLs .........................................................9

Annex B (informative) Additional elements for the clinical investigation of TIOLs.........................................14

Annex C (informative) Additional elements for the clinical investigation of multifocal IOLs ................19

Annex D (informative) Additional elements in the clinical investigation of accommodating IOLs ..22

Annex E (informative) Evaluation of post-operative adverse events and visual acuity rates.................27

Annex F (informative) Clinical tests ...................................................................................................................................................................31

Annex G (informative) Statistical methods and sample size calculations ..................................................................37

Bibliography .............................................................................................................................................................................................................................42

© ISO 2018 – All rights reserved iii
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SIST EN ISO 11979-7:2018
ISO 11979-7:2018(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 fourth edition cancels and replaces the third edition (ISO 11979-7:2014). It also cancels and

replaces the first edition of ISO 11979-9:2006 and its amendment ISO 11979-9:2006/Amd 1:2014.

The main changes compared to the previous edition are as follows:
— Integration of the multifocal intraocular lens document (ISO 11979-9:2006);

— Technical updates concerning the safety and efficacy of the intraocular lens subtypes monofocal,

multifocal, toric and accommodating;
— Recommendations for the clinical investigations of novel lens models; and

— The separation of guidance for intraocular lenses used in cases of aphakia, and intraocular lens used

for the correction of ametropia in phakic patients.
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 11979-7:2018
ISO 11979-7:2018(E)
Introduction

Intraocular lenses (IOLs) are used to correct residual refractive errors in subjects who have aphakia.

Such residual refractive errors typically include sphere and astigmatism, but can also include

accommodation. Different designs of IOLs can be used to correct for specific refractive errors. In the

case where an IOL is designed to provide more than one type of refractive correction, that IOL will have

to satisfy each of the separate requirements of those correction designs.

This document provides requirements and recommendations for intraocular lens investigations of new

IOL models. In the case where an IOL model is a modification of a parent IOL model, a risk analysis can

be used in order to determine the appropriate level of testing.
© ISO 2018 – All rights reserved v
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SIST EN ISO 11979-7:2018
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SIST EN ISO 11979-7:2018
INTERNATIONAL STANDARD ISO 11979-7:2018(E)
Ophthalmic implants — Intraocular lenses —
Part 7:
Clinical investigations of intraocular lenses for the
correction of aphakia
1 Scope

This document specifies the particular requirements for the clinical investigations of intraocular lenses

that are implanted in the eye in order to correct aphakia.
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 11979-10:2018, Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of

intraocular lenses for correction of ametropia in phakic eyes

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 14971, Medical devices — Application of risk management to medical devices
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
© ISO 2018 – All rights reserved 1
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SIST EN ISO 11979-7:2018
ISO 11979-7:2018(E)
CNVA corrected near visual acuity
DCIVA distance corrected intermediate visual acuity
DCNVA distance corrected near visual acuity
4 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 IOL model is a modification of a parent IOL for which the safety and performance have already

been established through clinical investigation in accordance with this document, then a limited or

[1]

no additional clinical investigation can suffice. ISO/TR 22979 provides guidance in determining the

need for a clinical investigation.
5 Ethical considerations

For clinical investigations of medical devices for human subjects, the ethical requirements in

ISO 14155 apply.
6 General requirements
6.1 General

There are four main categories of intraocular lenses that are determined by optical design:

a) monofocal (IOL);
b) multifocal (MIOL);
c) toric (TIOL); and
d) accommodating (AIOL).

The same basic requirements apply to all of the IOL types. Additional requirements apply to MIOL,

TIOL, and AIOL.
There is a further subdivision depending on anatomic placement of the IOL:
— posterior chamber; and
— anterior chamber.

Posterior chamber lenses are placed behind (posterior to) the iris. Anterior chamber lenses are placed

in front of (anterior to) the iris. Additional requirements apply in the case of anterior chamber lenses.

6.2 Design of a clinical investigation
6.2.1 Requirements for all types of IOLs

A clinical investigation shall be designed to compare the rates of adverse events and visual acuities

above defined thresholds of the model IOL to the results of historical data. Annex A provides general

guidance for the design of a clinical investigation of IOLs. Historical data can be found in Annex E.

2 © ISO 2018 – All rights reserved
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SIST EN ISO 11979-7:2018
ISO 11979-7:2018(E)
6.2.2 Additional requirements for toric IOLs (TIOLs)

Prior to any clinical investigation of a toric intraocular lens, the rotational stability of a mechanically

and geometrically equivalent non-toric version of that IOL model 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 (Form 0) and that measured at Form 4

and subsequent Forms. (See A.3 for recommendations on reporting periods). The absolute value of the

rotation shall be less than 10° in 90 % of the cases and less than 20° in 95 % of the cases.

Subsequently, if found necessary by risk analysis (e.g. to assess the clinical performance of low cylinder

power TIOLs), a clinical investigation can be performed using the toric version of the model.

Subjects that undergo a secondary surgery to correct postoperative 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 later in the clinical investigation shall be performed prior to the

secondary surgery, wherever possible. (See Annex D.)
Additional elements for investigations of TIOLs are outlined in Annex B.
6.2.3 Additional requirements for multifocal IOLs (MIOLs)

For multifocal designs with two or more intended foci, a clinical investigation shall evaluate the safety

and performance of vision at far as well as any additional intended focal distances.

The clinical investigation plan shall include a defocus evaluation.
A phased enrolment as outlined in Annex C shall be considered.
Additional elements for MIOLs are outlined in Annex C.
6.2.4 Additional requirements for accommodating IOLs (AIOLs)

A controlled clinical investigation of an AIOL shall evaluate the accommodative amplitude and the

additional safety and performance aspects related to the risk assessment. Annex D identifies safety

and performance aspects for consideration. The clinical investigation plan shall include at least one

objective method to measure accommodative amplitude.

The investigation enrolment shall consist of two phases (see Annex D). The second phase shall begin

only if the first phase has demonstrated that the IOL design provides an average of at least 1,0 D of

objective accommodation. In order for the design to be designated as an AIOL, the overall investigation

shall demonstrate objective accommodation of 1,0 D or more at the point of accommodative stability

(see Annex D).
Additional elements for AIOLs are outlined in Annex D.
6.2.5 Additional requirements for anterior chamber IOLs

A clinical investigation of an anterior chamber IOL shall evaluate the change in endothelial cell density,

hexagonality and coefficient of variation of endothelial cell area, the clearance between the surfaces

of the anterior chamber IOL and the posterior surface of the cornea and the iris, the anterior chamber

angle (including observations of pigment and synechiae), and any additional safety and performance

aspects related to the risk assessment.
© ISO 2018 – All rights reserved 3
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SIST EN ISO 11979-7:2018
ISO 11979-7:2018(E)
6.3 Characteristics of clinical investigations
6.3.1 General

The clinical investigation plan shall provide information regarding characteristics to be studied, and

instructions regarding the methods and documentation of these characteristics. Whenever possible,

objective methods, such as photographic imaging, shall be used.

If additional claims are to be made, additional corresponding characteristics shall be studied.

If several types of IOLs are combined, the characteristics of each IOL subtype in the combination shall

be fully considered.
6.3.2 Characteristics to be studied for all types of IOLs
The following characteristics shall be considered:
a) CDVA;
b) visual acuity at all intended distances with far correction;
c) intraocular pressure;
d) corneal status;
e) signs of inflammation:
— anterior chamber cells,
— anterior chamber flare,
— cystoid macular oedema,
— hypopyon, and
— endophthalmitis.
f) pupillary block;
g) retinal detachment;
h) status of anterior and posterior capsule;
[2]
i) IOL decentration ;
[2]
j) IOL tilt ;
k) IOL discoloration; and
l) IOL opacity.
6.3.3 Additional characteristics to be studied for TIOLs
a) IOL rotational stability; and
b) corneal astigmatism:
— prior to surgery;
— intended surgical position (Form 0); and
— post-surgical.
4 © ISO 2018 – All rights reserved
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SIST EN ISO 11979-7:2018
ISO 11979-7:2018(E)
6.3.4 Additional characteristics to be studied for MIOLs
a) uncorrected visual acuity at all intended focal distances;
b) contrast sensitivity;
c) defocus evaluation;
d) pupil size under photopic and mesopic conditions; and
e) fundus visualization.
6.3.5 Additional characteristics to be studied for AIOLs
a) objective accommodative amplitude;
b) uncorrected visual acuity at distance, intermediate and near;
c) visual acuity at near and intermediate using far correction;

d) additional refraction (over distance correction) required to achieve any improvement in near

visual acuity;
e) contrast sensitivity;
f) defocus evaluation; and
g) pupil size.
6.3.6 Additional characteristics applying to anterior chamber IOLs
a) specular microscopy;
b) anterior chamber depth measurement; and
c) gonioscopy.
6.3.7 Additional characteristics

If justified by the risk analysis, the following additional characteristics shall be considered:

a) cycloplegic refraction;
b) specular microscopy;
c) gonioscopic examination;
d) pupil size; and
e) anterior chamber depth measurement.
6.4 Duration of the investigations
[1]

Consult ISO/TR 22979 for guidance on investigation duration for modifications of lens models for

which safety and performance have previously been established through clinical investigation.

For posterior chamber IOLs that are not modifications of a model for which safety and performance

data have been previously established through clinical investigation, the minimum duration of the

clinical investigations shall be Form 5 (see Annex A for recommended visit window tolerances).

© ISO 2018 – All rights reserved 5
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SIST EN ISO 11979-7:2018
ISO 11979-7:2018(E)

For anterior chamber IOLs that are not modifications of a model for which safety and performance data

have been previously established through clinical investigation, the minimum duration of the clinical

investigations shall be 3 years (see Annex A for recommended visit window tolerances).

For all TIOLs, a study of the non-toric version of the IOL shall be performed to ensure rotational stability

through Form 4. TIOLs that are not a modification of a respective parent IOL shall require a full clinical

investigation through Form 5 for posterior chamber IOLs, and 3 years duration for anterior chamber IOLs.

For TIOLs that are a modification of an IOL parent, the rotational stability assessment shall have a

duration through Form 4. If a subsequent clinical investigation of the TIOL is performed, it shall also

have a duration through Form 4.

For all AIOLs, the minimum clinical study duration shall be Form 5, but can require up to 3 years, based

on accommodative stability.

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 who have been

enrolled in the investigation, including subjects whose IOL was r
...

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