SIST EN ISO 11979-7:2024
(Main)Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024)
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024)
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 11979-7:2024)
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 11979-7:2024)
Le présent document spécifie les exigences particulières applicables aux investigations cliniques de lentilles intraoculaires destinées à être implantées dans l’œil pour corriger l’aphakie.
Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave intraokularnih leč za korekcijo afakije (ISO 11979-7:2024)
Ta dokument določa posebne zahteve za klinične raziskave intraokularnih leč, ki se vstavijo v oko za korekcijo afakije.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN ISO 11979-7:2018
Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave
intraokularnih leč za korekcijo afakije (ISO 11979-7:2024)
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular
lenses for the correction of aphakia (ISO 11979-7:2024)
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen von
Intraokularlinsen für die Korrektion von Aphakie (ISO 11979-7:2024)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques de
lentilles intraoculaires pour la correction de l'aphakie (ISO 11979-7:2024)
Ta slovenski standard je istoveten z: EN ISO 11979-7:2024
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11979-7
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2024
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11979-7:2018
English Version
Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations of intraocular lenses for the correction of
aphakia (ISO 11979-7:2024)
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 11979-7:2024)
11979-7:2024)
This European Standard was approved by CEN on 19 January 2024.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-7:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11979-7:2024) 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 July 2024, and conflicting national standards shall be
withdrawn at the latest by July 2024.
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 11979-7:2018.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11979-7:2024 has been approved by CEN as EN ISO 11979-7:2024 without any
modification.
International
Standard
ISO 11979-7
Fifth edition
Ophthalmic implants — Intraocular
2024-01
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 11979-7:2024(en) © ISO 2024
ISO 11979-7:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 11979-7:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and 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 .3
6.2.1 Requirements for all types of IOL .3
6.2.2 Additional requirements for toric IOLs (TIOL).3
6.2.3 Additional requirements for Simultaneous Vision IOL (SVIOL) including MIOL,
EDF and FVR lenses .3
6.2.4 Additional requirements for accommodating IOLs (AIOL) .4
6.2.5 Additional requirements for anterior chamber IOLs .5
6.3 Characteristics of clinical investigations .5
6.3.1 General .5
6.3.2 Characteristics to be studied for all types of IOL .5
6.3.3 Additional characteristics to be studied for toric IOL .6
6.3.4 Additional characteristics to be studied for SVIOLs .6
6.3.5 Additional characteristics to be studied for accommodating IOL.6
6.3.6 Additional characteristics applying to anterior chamber IOLs .6
6.3.7 Additional characteristics . . .6
6.4 Duration of the investigations .7
6.5 Enrolment .7
6.6 Bilateral implantation .7
6.7 Surgical technique .8
6.8 Examination and treatment of subjects .8
6.9 Adverse events reports .8
6.10 Inclusion and exclusion criteria .8
6.10.1 General .8
6.10.2 General inclusion criteria .8
6.10.3 Additional inclusion criteria for toric IOL .8
6.10.4 General exclusion criteria .9
6.10.5 Additional exclusion criteria for simultaneous vision IOL .9
6.10.6 Additional exclusion criteria for anterior chamber IOL .9
Annex A (normative) General elements in the clinical investigation of IOLs .11
Annex B (informative) Additional elements for the clinical investigation of toric IOLs .16
Annex C (informative) Additional elements for the clinical investigation of simultaneous vision
(SVIOL) IOLs .21
Annex D (informative) Additional elements for the clinical investigation of accommodating IOLs .29
Annex E (informative) Evaluation of post operative adverse events and visual acuity rates .34
Annex F (informative) Clinical tests .38
Annex G (informative) Statistical methods and sample size calculations .46
Bibliography .51
iii
ISO 11979-7:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of 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 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, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 170, Ophthalmic optics, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement)
This fifth edition cancels and replaces the fourth edition (ISO 11979-7:2018), which has been technically
revised. The changes related herein for updating the document to the fifth edition apply to devices that will
enter the marketplace after the date of publication of the fifth edition and are not designed or meant to limit
any devices currently approved and marketed, nor those devices in the process of approval.
The main changes are as follows:
— development of definitions of non-accommodative posterior chamber “Simultaneous Vision Range”
(SVIOL) lenses that include the subtypes of MIOL (Multifocal), EDF (Extended Depth of Focus) and FVR
(Full Visual Range) IOLs, and defining each of these IOL types to allow differentiation among the lens
types based on clinical and safety performance measures;
— establishment of guidelines for clinical testing of newly defined IOL types as listed above as well as
related novel lens types, with alignment of testing methodologies among the lens types;
— ISO 11979-1, ISO 11979-2, ISO 11979-4 and ISO/TR 22979 are under revision and, when published, will
be aligned with this edition of ISO 11979-7.
A list of all parts in the ISO 11979 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO 11979-7:2024(en)
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 may also correct for a lack of
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.
v
International Standard ISO 11979-7:2024(en)
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, 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 and 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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.2 Abbreviated terms
UDVA uncorrected distance visual acuity
UIVA uncorrected intermediate visual acuity
UNVA uncorrected near visual acuity
BSCVA best spectacle corrected visual acuity
CDVA corrected distance visual acuity
CS contrast sensitivity
ISO 11979-7:2024(en)
CNVA corrected near visual acuity
DCIVA distance corrected intermediate visual acuity
DCNVA distance corrected near visual acuity
SE spherical equivalent refraction
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 no additional
clinical investigation shall suffice.
[2]
ISO/TR 22979 provides guidance in determining the need for a clinical investigation. The outcomes of
[1]
optical evaluation performed according to in ISO 11979-2 can be used to include or exclude characteristics
to be studied in 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 and/or clinical
characteristics or performance:
a) monofocal (IOL);
b) toric (TIOL);
c) simultaneous vision lens (SVIOL): non accommodative lenses of three sub-categories that provide
simultaneous vision at multiple distances with EDF and FVR IOLs classified as non-inferior to monofocal
lenses at far:
— multifocal (MIOL); lens implants that emphasize optical and functionally useful acuity levels at far, but
when compared to the monofocal control lens, also have improved optical and clinical performances
at near focal distances. Multifocal lenses (MIOLs) have additional requirements for near vision;
— extended depth of focus (EDF IOL); lens implants that emphasize optical and functionally useful
acuity levels at far but also from far through intermediate focal distances. Extended depth of focus
lenses (EDF IOLs) have additional requirements for intermediate vision;
— full visual range IOL (FVR IOL) lens implants that emphasize optical and functionally useful acuity
levels at far but also from far through intermediate and up to near focal distances. Full visual range
lenses (FVR IOLs) have additional requirements at intermediate and near vision;
d) Accommodating (AIOL).
The same basic requirements apply to all of the IOL types. Additional requirements apply to TIOL, SVIOL,
AIOL and anterior chamber IOLs.
ISO 11979-7:2024(en)
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 IOL
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. The requirements of Annex A shall apply
for the design of a clinical investigation of IOLs. Historical data can be found in Annex E.
6.2.2 Additional requirements for toric IOLs (TIOL)
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 to be performed 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 Simultaneous Vision IOL (SVIOL) including MIOL, EDF and FVR
lenses
6.2.3.1 General
For SVIOL optical designs, a clinical investigation shall evaluate the safety and performance of vision at far as
well as any additional intended defined focal distances (e.g., intermediate and/or near). Clinically significant
acuity shall be defined as < 0,20 logMAR. All visual acuity items in the table relate to mean monocular
photopic visual acuity.
Intermediate visual performance shall be assessed with best distance correction at 66 cm. Near visual
performance shall be assessed with best distance correction at 40 cm. Additional testing distances may be
used based on the lens design.
In order to minimize pseudo-accommodation, the monofocal IOL used for the control group should be
aspheric, commercially available and one for which the selection has been justified.
For all types of SVIOLs, depth of focus testing shall be performed as described in F.3. Specifically for EDF
IOLs, such testing is considered a performance requirement and shall meet the criterion listed in Table 1.
Visual acuity performance necessary to meet the requirements in Table 1 shall be obtained using visual
acuity charts at distances listed in Table 1, or taken from the depth of focus curve which is generated as
ISO 11979-7:2024(en)
described in F.3. The full depth of focus curve as described in F.3 shall be used to characterize the IOL
performance with sufficient precision for inclusion in the labelling of the SVIOL.
The specific effectiveness requirements are related to the type of SVL as listed Table 1 shall be met.
Table 1 — Additional requirements for simultaneous visions IOLs
Category FAR INTERMEDIATE (66 cm) NEAR (40 cm)
SVIOL ∆ (mesopic CS) ≤ 0,3 log units
a
at any frequency
all types
b
MIOL CDVA ≤ 0,20 logMAR DCNVA superior to control
EDF IOL CDVA non-inferior to control DCIVA ≤ 0,20 logMAR
0,10 logMAR level
EDF IOL DCIVA superior to control
c
EDF IOL Negative defocus range at the 0,20 logMAR threshold is ≥0,5 D greater than control
EDF IOL DCVA at 1,0 m ≤ 0,20 logMAR
FVR IOL CDVA non-inferior to control
0,10 logMAR level
FVR IOL DCIVA ≤ 0,20 logMAR DCNVA ≤ 0,20 logMAR
FVR IOL DCIVA superior to control DCNVA superior to control
FVR IOL DCVA at 1,0 m and 50 cm < 0,20 logMAR
a.
∆ (mesopic CS) is the difference of the mean contrast sensitivity of the test IOL group minus the mean contrast sensitivity of
the control IOL group, each tested under monocular conditions without glare.
b.
Visual performance shall meet or exceed 0,20 logMAR in order to prevent performance values to be rounded down to
0,20 logMAR.
c.
Refer to Annex F for clinical testing and related references. Visual acuity performance necessary to meet the requirements
in Table 1 may be obtained using visual acuity charts at distances listed in Table 1 or taken from the defocus curve which was
generated as described in F.3. The full defocus curve as described in F.3 is required to characterize the defocus performance with
sufficient precision for inclusion in the labelling for the SVIOL.
6.2.3.2 Depth of focus testing
Depth of focus evaluations shall be performed on all SVIOL types. See Annex F for additional guidance.
6.2.3.3 Safety requirements
The mean mesopic monocular far contrast sensitivity (without glare) for all SVIOL shall be no worse than
0,3 log units below that of the control at any test spatial frequency. Annex C identifies additional safety and
performance requirements for consideration.
NOTE The 0,3 log unit at one spatial frequency is from review of the Summary of Safety and Effectiveness Documents
[3]
(SSED’s) of approved MIOL’s .
6.2.4 Additional requirements for accommodating IOLs (AIOL)
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. Annex F includes depth of focus testing guidance. The clinical investigation plan
shall include at least one objective method to measure accommodative amplitude.
The investigation enrollment 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.
ISO 11979-7:2024(en)
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.
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 IOL
The following characteristics shall be considered for all types of IOLs:
a) CDVA;
b) manifest (subjective) refraction;
c) visual acuity at all intended distances with far correction;
d) intraocular pressure;
e) corneal status;
f) signs of intraocular inflammation:
— anterior chamber cells;
— anterior chamber flare;
— cystoid macular oedema;
— hypopyon; and
— endophthalmitis;
g) pupillary block;
h) retinal detachment;
i) status of anterior and posterior capsule;
[4]
j) IOL decentration ;
[4]
k) IOL tilt ;
l) IOL discoloration;
m) IOL opacity;
n) glistenings in IOL;
ISO 11979-7:2024(en)
o) visualization of posterior pole through IOL.
6.3.3 Additional characteristics to be studied for toric IOL
The following additional characteristics shall be considered for toric IOLs:
a) IOL rotational stability, and
b) measured surgical position (Form 0); and pre and post surgical corneal astigmatism.
6.3.4 Additional characteristics to be studied for SVIOLs
The following additional characteristics shall be considered for SVIOLs:
a) depth of focus testing;
b) uncorrected visual acuity at far and intermediate and/or near, as applicable to the type of IOL;
c) intermediate and/or near visual acuity with best distance correction, as applicable to the type of IOL;
d) patient reported outcome (PRO) survey to assess visual symptoms related to the optical properties of
the IOL for bilateral implantation of SVIOL;
e) rate of secondary surgical interventions;
f) far contrast sensitivity.
6.3.5 Additional characteristics to be studied for accommodating IOL
The following additional characteristics shall be considered for accomodating IOLs:
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) far contrast sensitivity;
f) pupil size;
g) PRO survey to assess visual symptoms related to the optical properties of the IOL;
h) rate of secondary surgical interventions.
6.3.6 Additional characteristics applying to anterior chamber IOLs
The following additional characteristics shall be considered for anterior chamber IOLs:
a) specular microscopy;
b) anterior chamber depth measurement;
c) gonioscopy.
6.3.7 Additional characteristics
If justified by the risk analysis, the following additional characteristics shall be considered:
a) cycloplegic refraction;
ISO 11979-7:2024(en)
b) specular microscopy;
c) gonioscopic examination;
d) pupil size;
e) anterior chamber depth measurement.
6.4 Duration of the investigations
[2]
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 all types of 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).
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, an investigation of the non-toric version of the IOL shall be performed to ensure rotational
stability through Form 4. Toric IOLs 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 SVIOL that are a modification of an IOL parent, the minimum duration of the clinical investigation shall
be through Form 4.
For all AIOLs, the minimum clinical investigation 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 removed repositioned or replaced, have
either completed follow up according to protocol or have passed the final visit window.
6.5 Enrolment
To minimize the risks associated with the clinical investigation of a new 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
next phase of the clinical investigation. Guidance on phased enrolment is included in Annex A (monofocal
IOL), Annex B (TIOL), Annex C (SVIOL), and Annex D (AIOL).
A risk analysis shall be performed to determine if an earlier additional phase (before Phase 1 listed in the
Annexes above) is needed to address specific safety issues associated with the IOL design.
6.6 Bilateral implantation
Any plans for fellow eye implantation shall be clearly described in the clinical investigation plan. Only the
first eye of each subject shall be included in the primary statistical analysis. When implantation of fellow
eyes is permitted, the clinical investigation plan shall specify the time period between implantation of
the first eye and the fellow eye. A risk analysis shall be used to guide necessary safety and efficacy data
requirements.
ISO 11979-7:2024(en)
Bilateral implantation shall not be implemented until initial safety and performance data have been
collected, evaluated and found acceptable by the sponsor and coordinating investigator (and regulatory
body, where applicable).
The review of data from at least 50 eyes at Form 4 shall be performed prior to fellow eye implantation.
Risk analysis can allow an earlier implantation in fellow eyes if sufficiently justified by previous clinical
experience.
6.7 Surgical technique
The clinical investigation plan shall contain descriptions of the surgical technique, the intraoperative
use of ophthalmic viscosurgical devices, and the use of preoperative, intraoperative and postoperative
medications. Any deviations shall be recorded on the case report forms.
6.8 Examination and treatment of subjects
The reporting periods shall be as described in Annex A.
The clinical investigation plan shall describe how subject visits and ophthalmic adverse events that occur
between standard reporting periods will be handled in the data analyses.
6.9 Adverse events reports
See ISO 14155.
6.10 Inclusion and exclusion criteria
6.10.1 General
The general inclusion criteria in 6.10.2 and the general exclusion criteria in 6.10.4 shall be considered.
Additional criteria as given in 6.10.3, 6.10.5 and in 6.10.6 shall be considered depending on the risk analysis
for the particular IOL model.
6.10.2 General inclusion criteria
The following general inclusion criteria shall be considered:
a) adult;
b) cataract;
c) calculated IOL power is within the range of the investigational IOL;
d) signed informed consent form;
e) clear intraocular media other than cataract.
6.10.3 Additional inclusion criteria for toric IOL
The following inclusion criteria for toric IOLs shall be considered:
a) corneal astigmatism within the range defined in the clinical investigation plan;
b) stability of the corneal astigmatism (for a minimum of 4 weeks);
c) dilated pupil size large enough to visualize TIOL axis markings postoperatively.
ISO 11979-7:2024(en)
6.10.4 General exclusion criteria
6.10.4.1 General exclusion criteria before surgery
The following general exclusion criteria shall exclude patients prior to surgery:
a) previous intraocular or corneal surgery;
b) traumatic cataract;
c) pregnancy or lactation;
d) concurrent participation in another drug or device investigation;
e) instability of keratometry or biometry measurements;
f) history of intraocular inflammation;
g) Subjects who may be reasonably expected to require a secondary surgical intervention at any time
during the investigation (other than YAG capsulotomy);
h) gonioscopic abnormalities;
i) irregular astigmatism.
6.10.4.2 General exclusion criteria at the time of surgery
Subjects who do not meet exclusion criteria describe in 6.10.4.1 and are enrolled in the study may present
findings during surgery that preclude inclusion of performance data in the investigation and thus need to be
excluded from data collection post operatively. The following general exclusion criteria shall be considered
during surgery:
— zonular instability;
— need for iris manipulation;
— capsular fibrosis or other opacity;
— inability to fixate IOL in desired position.
If the IOL has touched the eye, it should be noted if the reason for exclusion is related to the IOL itself
and/or any insertion device (e.g. IOL or insertion device defect causing capsular damage, malfunction of
insertion device). In cases where the IOL has touched the eye, the subject should be followed, for safety, until
completion of the investigation.
6.10.5 Additional exclusion criteria for simultaneous vision IOL
Subjects shall not have more than 1 D of pre-operative corneal astigmatism.
6.10.6 Additional exclusion criteria for anterior chamber IOL
The criteria for the specific AC IOL platform shall comply with the specific intended IOL design as described
in this subclause, including TIOL, AIOL and MIOL.
a) angle abnormalities;
b) glaucoma or ocular hypertension;
c) angle or anterior chamber anatomy unsuitable to accept IOL design safely;
d) minimum anterior chamber depth related to design;
ISO 11979-7:2024(en)
e) endothelial issues:
— endothelial cell density less than listed in ISO 11979-10:2018, Table 1;
— percent hexagonality of endothelial cell shape ≤45 %;
— coefficient of variation of endothelial cell area >0,45;
— any endothelial conditions putting the cornea at risk of failure.
f) corneal oedema.
ISO 11979-7:2024(en)
Annex A
(normative)
General elements in the clinical investigation of IOLs
A.1 Overview
This annex provides elements of a clinical investigation plan (CIP) that assist in collecting data for the
purpose of determining the safety and performance of all types of IOLs.
A.2 Investigation design and duration
A.2.1 General
The suggested clinical investigation design is uncontrolled and designed to compare outcomes with the
historical safety and performance endpoints in Annex E at the final follow-up.
NOTE 1 In case of an investigation with a concurrent control group, the number of subjects should be calculated to
be sufficient to detect differ
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