EN ISO 11979-7:2014

SLOVENSKI STANDARD
01-november-2014
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SIST EN ISO 11979-7:2006
SIST EN ISO 11979-7:2006/A1:2012
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Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-
7:2014)
Ophthalmische Implantate – Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-
7:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO
11979-7:2014)
Ta slovenski standard je istoveten z: EN ISO 11979-7:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11979-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2014
ICS 11.040.70 Supersedes EN ISO 11979-7:2006
English Version
Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations (ISO 11979-7:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Ophthalmische Implantate - Intraokularlinsen - Teil 7:
Investigations cliniques (ISO 11979-7:2014) Klinische Prüfungen (ISO 11979-7:2014)
This European Standard was approved by CEN on 18 July 2014.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-7:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11979-7:2014) 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 March 2015, and conflicting national standards shall be withdrawn at
the latest by March 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11979-7:2006.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11979-7:2014 has been approved by CEN as EN ISO 11979-7:2014 without any modification.
INTERNATIONAL ISO
STANDARD 11979-7
Third edition
2014-09-01
Ophthalmic implants — Intraocular
lenses —
Part 7:
Clinical investigations
Implants ophtalmiques — Lentilles intraoculaires —
Partie 7: Investigations cliniques
Reference number
ISO 11979-7:2014(E)
©
ISO 2014
ISO 11979-7:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, 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
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 11979-7:2014(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Justification for a clinical investigation . 1
5 Ethical considerations . 1
6 General requirements . 1
6.1 General . 1
6.2 Design . 2
6.3 Characteristics . 2
6.4 Investigation duration . 4
6.5 Enrollment . 4
6.6 Bilateral implantation . 4
6.7 Surgical technique . 4
6.8 Examination and treatment of subjects. 5
6.9 Adverse events reports . 5
6.10 Inclusion and exclusion criteria . 5
Annex A (informative) Elements of a clinical investigation . 7
Annex B (informative) Evaluation of post-operative adverse event and visual acuity rates .15
Annex C (informative) Additional elements for toric IOLs .19
Annex D (informative) Additional elements for accommodating IOLs .26
Annex E (informative) Clinical tests .35
Bibliography .41
ISO 11979-7:2014(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. 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. 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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the third edition (ISO 11979-7:2006), which has been technically
revised. It also incorporates the Amendment ISO 11979-7:2006/Amd1:2012 .
ISO 11979 consists of the following parts, under the general title Ophthalmic implants — Intraocular
lenses:
— Part 1: Vocabulary
— Part 2: Optical properties and test methods
— Part 3: Mechanical properties and test methods
— Part 4: Labelling and information
— Part 5: Biocompatibility
— Part 6: Shelf-life and transport stability testing
— Part 7: Clinical investigations
— Part 8: Fundamental requirements
— Part 9: Multifocal intraocular lenses
— Part 10: Phakic intraocular lenses
iv © ISO 2014 – All rights reserved

INTERNATIONAL STANDARD ISO 11979-7:2014(E)
Ophthalmic implants — Intraocular lenses —
Part 7:
Clinical investigations
1 Scope
This part of ISO 11979 specifies particular requirements for clinical investigations for posterior and
anterior chamber intraocular lenses (IOLs).
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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: Phakic intraocular lenses
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
For the purposes of this document, the terms and definitions given in ISO 11979-1 and ISO 14155 apply.
4 Justification for a clinical investigation
If the need for a clinical investigation is identified, the requirements of ISO 14155 shall apply, with
additional requirements given below.
If a new IOL model is a modification of a model for which the safety and performance have been
established through clinical investigation in accordance with this part of ISO 11979 no or limited
[1]
clinical investigation is needed. ISO/TR 22979 provides guidance in determining whether or not a
modification is minor.
5 Ethical considerations
For clinical investigations of medical devices for human subjects, the requirements in ISO 14155 shall
apply.
6 General requirements
6.1 General
The requirements for a clinical investigation given in ISO 14155 shall apply, with additional requirements
given below.
ISO 11979-7:2014(E)
6.2 Design
6.2.1 General
A clinical investigation shall be designed to compare results to historical data on adverse events and
visual acuity rates. Annex A provides general guidance for the design of a clinical investigation. Historical
data can be found in Annex B.
6.2.2 Additional requirements for toric IOLs
For all toric IOLs, the rotational stability of a non-toric version that is mechanically and geometrically
equivalent to the toric IOL shall be demonstrated.
The following performance criteria for rotational stability shall be fulfilled: the rotation of the meridian
defined by the IOL axis indicator as measured and compared between Day 0 (the day of surgery) post-
operative examination and the form 4 examination shall be less than 10° in 90 % of the cases, less than
20° in 95 % of the cases, and less than 30° in 99 % of the cases.
Then, if necessary due to risk analysis, a clinical investigation shall be performed using the toric version
of the model.
In the event that a toric IOL clinical investigation is required due to risk analysis, the subjects that
undergo secondary surgery to correct IOL axis mark rotation shall have their clinical results prior to
the secondary surgery carried forward as the final results for that subject. In the case of examinations
scheduled to be performed later in the clinical investigation, the sponsor shall consider requiring each
of these examinations to be performed prior to the secondary surgery, if possible.
Additional elements for toric IOLs are outlined in Annex C.
6.2.3 Additional requirements for accommodating IOLs
A controlled clinical investigation of an accommodating IOL shall evaluate the additional safety and
performance concerns, specifically including the evaluation of accommodative amplitude using at least
one objective method. Guidance on clinical investigation of accommodating IOLs is outlined in Annex D.
It shall consist of two phases, with phase two beginning only after the first phase has demonstrated
that the accommodating IOL provides an average of at least 1 D of objective accommodation. The overall
study shall demonstrate that the accommodating IOL also provides 1 D of objective accommodation at
the point of stabilization.
6.3 Characteristics
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 shall be used, such as photographic imaging.
The following characteristics shall be considered. If additional claims are to be made, additional
corresponding characteristics shall be studied.
6.3.1 General characteristics
a) best spectacle corrected visual acuity (BSCVA);
b) subjective refraction;
c) intraocular pressure;
d) corneal status;
2 © ISO 2014 – All rights reserved

ISO 11979-7:2014(E)
e) signs of inflammation:
1) anterior chamber cells;
2) anterior chamber flare;
3) cystoid macular oedema;
4) hypopyon;
5) 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;
l) IOL opacity.
6.3.2 Toric IOL characteristics
a) uncorrected visual acuity;
b) keratometry;
c) IOL mark axis rotation.
6.3.3 Accommodating IOL characteristics
a) uncorrected visual acuity at distance, intermediate and near;
b) visual acuity at near and intermediate with best distance correction;
c) best corrected near visual acuity;
d) additional refraction (over best distance subjective correction) required to achieve best corrected
near acuity;
e) objective accommodative amplitude;
f) contrast sensitivity;
g) subject questionnaire;
h) pupil size.
6.3.4 Additional characteristics
If justified by the risk analysis, these additional characteristics shall be considered.
a) cycloplegic refraction;
b) specular microscopy;
c) gonioscopic examination;
d) pupil size;
ISO 11979-7:2014(E)
e) anterior chamber depth measurement.
6.4 Investigation duration
The minimum duration of the clinical investigations shall be one year (see Annex A for visit window
tolerance) for aphakic posterior chamber IOLs which are not modifications of a model for which safety
and performance data have been established through clinical investigation.
The minimum duration of the clinical investigations shall be three years (see Annex A for visit window
tolerance) for aphakic anterior chamber IOLs which are not modifications of a model for which safety
and performance data have been established through clinical investigation.
For all toric IOLs, a six-month study of the non-toric version of the IOL shall be performed to ensure
rotational stability. Then for toric IOLs that are a modification of an IOL that has met the requirements
of all parts of ISO 11979, risk analysis may require that this rotational stability study is followed by a
clinical investigation of the actual toric IOL for six months. Toric IOLs that are not a modification of an
IOL that has met the requirements of all parts of ISO 11979 shall require a full clinical investigation of
one year duration.
The minimum study duration for accommodating IOLs through clinical investigation shall be one year
but may require up to three years based on the risk analysis.
[1]
Consult ISO/TR 22979 for guidance on investigation duration for modifications of lens models for
which safety and performance have been established through 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 IOL was removed or replaced, have reached the
final reporting period.
6.5 Enrollment
To minimize the risks associated with the clinical investigation of a new IOL, subject enrollment 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, if applicable) prior to the continuation
of the clinical investigation. Guidance on phased enrollment is included in Annex A (monofocal IOL),
Annex C (toric IOL) and Annex D (accommodating IOL).
Risk analysis should be used to determine if an earlier phase than the phase 1 listed in the Annexes
above is needed to address safety issues associated with the IOL design.
6.6 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 the risk analysis, if
applicable). Only the first eye of each subject shall be included in the primary statistical analysis.
When implantation of fellow eye is permitted, the clinical investigation plan shall specify time period
between implantation of first eye and of fellow eye, based upon risk analysis.
NOTE The review of data from at least 50 eyes with six months of follow-up is recommended prior to fellow
eye implantation. Risk analysis might 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 deviation shall be recorded on the case report forms.
4 © ISO 2014 – All rights reserved

ISO 11979-7:2014(E)
For toric IOLs, the clinical investigation plan shall specify the type and location of the incision. The
estimated effect of the incision on the corneal astigmatism shall be used in the protocol for choosing the
appropriate cylindrical power.
6.8 Examination and treatment of subjects
The reporting periods are 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
Serious adverse events and all adverse device effects shall be reported using a special case report
form and forwarded to the sponsor as required. All other ophthalmic adverse events shall be reported
using either the standard visit case report form or specific adverse event forms and be collected during
monitoring. Non-ophthalmic events that are non-serious are not required to be reported.
6.10 Inclusion and exclusion criteria
6.10.1 General
The following inclusion/exclusion criteria shall be considered. Additional criteria shall be included
depending on the risk analysis for the particular IOL model.
6.10.1.1 Inclusion criteria
a) adult;
b) cataract (does not apply for phakic IOL);
c) best corrected visual acuity projected to be 0,2 logMAR or lower;
d) calculated IOL power is within the range of the investigational IOL;
e) signed informed consent form.
6.10.1.2 Exclusion criteria
a) previous intraocular and corneal surgery;
b) traumatic cataract;
c) pregnancy and lactation;
d) concurrent participation in another drug or device investigation.
6.10.2 Additional criteria for toric IOL
6.10.2.1 Inclusion criteria
a) corneal cylindrical error within the range defined in the clinical investigation plan (CIP);
b) stability of the cornea has been demonstrated by keratometry;
c) expected dilated pupil size at least large enough to visualize the axis markings.
6.10.2.1.1 Additional inclusion criteria for phakic toric IOLs
ISO 11979-7:2014(E)
a) the inclusion criteria described in ISO 11979-10 shall be considered.
6.10.2.2 Exclusion criteria
6.10.2.2.1 Additional exclusion criteria for phakic toric IOLs
The exclusion criteria described in ISO 11979-10 shall be considered.
6 © ISO 2014 – All rights reserved

ISO 11979-7:2014(E)
Annex A
(informative)
Elements of a clinical investigation
A.1 General
The following are elements of a clinical investigation plan which can assist in collecting data for the
purpose of determining the safety and performance of IOLs.
A.2 Number of subjects
The clinical investigation includes a minimum of 300 subjects when the results are compared to the
safety and performance end points in Annex B. In the case of an investigation with a concurrent control
group, calculate the number of subjects sufficient to detect differences in the safety and performance end
points in Annex B with similar statistical power to the investigation mentioned above. Any additional
claims, beyond those for safety and performance, require calculation of a sample size for that purpose.
To take into account that some subjects are lost during the course of the clinical investigation (including
deceased subjects and subjects who have the IOL explanted), enrol about:
a) 390 subjects in the one-year investigation;
b) 500 subjects in the three-year investigation.
Significantly larger numbers of subjects are not to be enrolled in order to minimize exposure to the risks
of a new IOL.
To assist in achieving a balance in the number of subjects from each investigator, each surgeon contributes
a minimum of 20 subjects, but no more than 25 % of the subjects in the investigation.
[1]
If the risk analysis determines that a limited clinical investigation is sufficient (see ISO/TR 22979 ),
then enroll 125 subjects.
A.3 Phased enrolment
To minimize the potential risks, the clinical investigation consists of two phases:
a) phase 1: a maximum of 100 subjects are included. After at least 50 of those have reached case report
form 4, their data are evaluated. If the results are acceptable, the next phase can begin;
b) phase 2: the remainder of the subjects are included.
A.4 Reporting periods
The time frames for the reporting periods are defined below:
a) case report form 0: pre-operative/operative reporting;
b) case report form 1: 1 or 2 days post-operatively;
c) case report form 2: 7 to 14 days post-operatively;
d) case report form 3: 30 to 60 days post-operatively;
ISO 11979-7:2014(E)
e) case report form 4: 120 to 180 days post-operatively;
f) case report form 5: 330 to 420 days post-operatively.
g) case report form 6: 630 to 780 days post-operatively;
h) case report form 7: 990 to 1 140 days post-operatively.
The minimum sample size needs to be achieved at each of the reporting periods.
A.5 Standardization of the clinical evaluation
Define criteria for evaluation of all studied variables. Define testing conditions for all measurements.
Before commencing the investigation instruct and train all investigators to use these, in order to obtain
data that can be combined for the purpose of statistical analysis.
A.6 Data analysis
Consider the following analyses for both the first eye group and the total eye group:
a) visual acuity (VA) stratified by age;
b) VA for best-case subjects;
c) VA stratified by adverse event;
d) VA stratified by pre-operative ocular pathology;
e) VA stratified by investigator;
f) subject-by-subject analysis of reasons why subject failed to achieve 0,3 logMAR VA;
g) frequency of, and the cause of loss of 10 letters or more on an EDTRS chart (or equivalent) compared
to best post-op visual acuity;
h) frequency of cumulative adverse events stratified by age;
i) frequency of persistent adverse events stratified by age;
j) adverse event stratified by investigator;
k) IOL related adverse events (two-sided 95 % confidence interval).
A.7 Subject accountability
The general requirement for accountability of subjects is given in ISO 14155. More specific guidance for
subject accountability at each of the post-operative visits in IOL clinical investigations is provided in
Table A.1.
8 © ISO 2014 – All rights reserved

ISO 11979-7:2014(E)
Table A.1 — Accountability by post-operative visit
Total num-
ber
Enrolled (N) — — —
Form 1 Form 2, etc. Final form
Subject status —
[n, % (n/N)] [n, % (n/N)] [n, % (n/N)]
Available for analysis —
Missing subjects: —
Discontinued —
Missing at scheduled visit but seen later —
Not seen but accounted for —
Lost to follow-up —
Active —
where
Enrolled: represents the total number of subjects enrolled in the investigation.
Available for analysis: represents the total number of subjects for whom data are available at the form.
Discontinued: represents the total number of subjects that have discontinued treatment prior to the form for
any reason (e.g. death or device replacement). This category does not include subjects that are lost to follow-up.
Missing at scheduled visit but seen later: represents the total number of subjects that were seen outside the
time window associated with the form.
Not seen but accounted for: represents the total number of subjects that were missing at the scheduled visit but
were accounted for by being contacted (e.g. by phone).
Lost to follow-up: represents the total number of subjects that have missed the form and there is no informa-
tion available about them.
Active: represents the total number of subjects that have not reached the time associated with the form. The
investigation at the form is considered completed when the number of active subjects is zero.
The following formula is used to determine the percentage of accountability for the investigation:
Availablefor Analysis
%Accountibility=
(Enrolled−Discontinued−−Active)
Depending upon the clinical investigation, the total number of subjects is not necessarily the total
number of eyes. For the purposes of this guidance, it is assumed that treatment is unilateral and that the
total number of subjects is equivalent to the total number of eyes.
To minimize the uncertainty in the data, the lost to follow-up subjects in the three-year investigation
should be less than 30 % and the lost to follow-up in one-year investigation should be less than 10 %.
A.8 Clinical case report forms
The following pages provide examples of case report forms for investigations of monofocal, spherical,
non-accommodating IOLs to correct aphakia:
a) pre-operative/operative case report form — posterior chamber lenses (Table A.2);
b) post-operative case report form — posterior chamber lenses (Table A.3);
c) pre-operative/operative case report form — anterior chamber lenses (Table A.4);
d) post-operative case report form — anterior chamber lenses (Table A.5);
e) adverse event case report form (Table A.6).
ISO 11979-7:2014(E)
Table A.2 — Pre-operative/operative case report form for posterior chamber lens clinical
investigation
Investigator name: _________________________________________ Clinical trial number: _ _ _ _
Patient number: _ _ _ _ Patient initials: ______ Sex: Male:  Race: Caucasian 
Female:   Black 
Asian 
Date of birth:                                                                                Other 
YY  MM  DD
Mixed 
_ _ _ _ _ _
Pre-operative report Irrigating solution used yes no
YY  MM  DD
 
Operative eye   right   left  If yes, specify ______________________
Operative eye Fellow eye Periocular medication yes (specify, if appropriate) no
Best corrected visual acuity _____ _____ Anaesthetic  _______________________ 
or check one:  Antibiotic  _______________________ 
inger count   Corticosteroid  _______________________ 
hand movement   Other (specify)  _______________________ 
light perception   Incision
no light perception  
Size  ____________ mm
IOP (applanation): Op. eye: ___ mmHg Fellow eye: ___ mmHg
Type (e.g., corneal, limbal, scleral tunnel) ______________
Corneal status (check yes or no for each) yes no
Normal   Type of lens extraction (check one)
Guttata  
Other pathology (specify) _______________  
Phacoemulsiication 
Cataract  Other (specify) __________________________ 
etiology (check one) senile  Type of capsulotomy (check one)
other (specify)___________  CCCR (continuous curvilinear capsulorhexis) 
Pathology (check yes or no for each) yes  no    not assessable Other (specify) __________________________ 
Pseudoexfoliation   
Glaucoma   Position of the loops (check one) in the bag 
Previous glaucoma iltering surgery    partly in the bag 
Poor pupil dilation    In the sulcus 
Previous uveitis    uncertain 
Previous retinal detachment    yes no
Diabetic Retinopathy    Other surgical procedures (check yes or no)  
Macular degeneration    If yes, specify: _____________________
Amblyopia  
Other (specify) _____________   Problems during surgery (check yes or no for each) yes no
Anterior segment bleeding  
Biometry K1________D Axial length_____mm
Iris damage  
K2________D
Target postoperative refraction _______________________ Posterior capsular opacity remaining  
Posterior capsular rupture  
Signed informed yes   _ _ _ _ _ _
Anterior vitrectomy  
consent obtained:
DD  MM   YY
Other(specify) ________________  

Operative report Date of surgery _ _ _ _ _ _
If investigation lens not implanted indicate reason:

DD  MM   YY
__________________________________________________
Ophthalmic viscosurgical device used yes  no 
If yes, specify ____________  Lens implanted. Place label here:

Intraocular medication (check yes or no for each) yes no
Adrenalin  
Time incision to closure ____________ min.
Acetylcholine   Signature of investigator
Carbachol  
Other (specify) ___________________                _ _ _ _ _ _
________________________     YY MM DD
10 © ISO 2014 – All rights reserved

ISO 11979-7:2014(E)
Table A.3 — Post-operative case report form for posterior chamber lens clinical investigation
Investigator name: _________________________________________ Clinical Trial Number: _ _ _ _
Patient number: _ _ _ _ Patient initials: ______ Date of birth: _ _ _ _ _ _ _

YY  MM  DD
_ _ _ _ _ _ Cont’d: Other pathology and complications
Post-operative report
YY   MM   DD
present    absent
Eye right  left  Fibrin in pupil  
Check if the patient is unavailable for this scheduled examination  Cortical remnants  
 
but continuing in the clinical investigation (sign form with all Nuclear remnants
 
evaluation in form left blank) IOL optic decentration

If the patient is discontinued from the investigation, indicate if present: ____ mm
 
primary reason: IOL optic tilt

_______________________________________________ if present: _____degrees
Refraction Sphere _____________ IOL dislocation out of the posterior chamber  
cylinder _____________ IOL optic discoloration  
 
axis _____________ IOL optic opacities
Keratometry K1________D Retinal detachment  
 
K2________D Diabetic retinopathy
Op. eye Fellow Cystoid macular oedema  
Best corrected visual acuity eye if present diagnosed:
______ ______ clinically                       

by luorescein angiography
or check one Finger count   Macular degeneration  
Hand movement   Optic atrophy  
Light perception   yes no
No light perception   Anterior capsular opaciication present?         
IOP (applanation)               _____________mm Hg Is the posterior capsule intact?  
Medications used up to this visit topical systemic   if intact:
(check yes or no for each)
yes no yes no posterior capsule ibrosis  
Corticosteroids     Elschnig’s pearls  
Antibiotics     if not intact:
NSAIDs     has the capsule been opened since
Glaucoma medication     the last reported visit?  
Other (specify) ____________________________________________ Other pathology?  
Corneal stromal oedema wound central specify:_____________________________________________
none  
 
mild/moderate If visual acuity less than 0,5 (20/40, 6/12) indicate main reason:
 
severe __________________________________________________
__________________________________________________
Iritis (check one) none 

mild
moderate  Has the operated eye undergone any surgical yes no

severe reintervention since last reported visit?  
Other pathology and complications present absent
If yes, specify:
(check present or absent for each)

__________________________________________________

Wound leak
 
Flat anterior chamber
 
Hyphema Has the patient experienced any adverse event yes no
 
 
Endophthalmitis   or ophthalmic adverse device effect?

if present
infectious   If yes, ill in the adverse event/ adverse device effect report form.


sterile

Vitreous in anterior chamber 
 
Vitreous to wound If serious, also contact the sponsor in accordance with local


Raised IOP requiring treatment regulations.


Pupillary block

 Signature of investigator
Anterior synechiae


Posterior synechiae


Deposits on IOL
_____________________________    _ _ _ _ __
YY  MM  DD
ISO 11979-7:2014(E)
Table A.4 — Pre-operative/operative case report form for anterior chamber lens clinical
investigation
Investigator name: _________________________________________ Clinical trial number: _ _ _ _
Patient number: _ _ _ _ Patient Initials: ______ Sex: Male:  Race: Caucasian 
Female:   Black 
Asian 
Date of birth:
Other 
YY  MM  DD                                                                                                      
Mixed
_ _ _ _ _ _ Irrigating solution used yes no
Pre-operative report
YY MM  DD
 
Operative eye   right   left  If yes, specify ______________________

Operative eye Fellow eye Periocular medication yes (specify, if appropriate) no

Best corrected visual acuity _____ _____ Anaesthetic  _______________________
or check one:  Antibiotic _______________________ 
inger count   Corticosteroid  _______________________ 
  
hand movement Other (specify)  _______________________
 
light perception
 
no light perception
Incision
IOP (applanation): Op. eye: ___ mmHg Fellow eye: ___ mmHg Size   ____________ mm
Type (e.g., corneal, limbal, scleral tunnel) ______________
Corneal status (check yes or no for each) yes no Type of lens extraction (check one)
 
Normal
Phacoemulsiication
Guttata   
  Other (specify) __________________________ 
Other pathology (specify) _______________
Endothelial cell count (if done): ______  cells/mm
Type of capsulotomy (check one)
Corneal thickness (if measured): _________  mm

Cataract

CCCR (continuous curvilinear capsulorhexis)
Etiology(check one) senile 

Other (specify) __________________________

other (specify)___________
Pathology (check yes or no for each) yes no not assessable yes no
Other surgical procedures (check yes or no)
Pseudoexfoliation    
  If yes, specify: _____________________
Glaucoma
 
Previous glaucoma iltering surgery
 
Poor pupil dilation
 
Previous uveitis Problems during surgery (check yes or no for each) yes no
Previous retinal detachment   Anterior segment bleeding  

   
Diabetic Retinopathy  Iris damage
 
  
Macular degeneration Posterior capsular opacity remaining
   
Amblyopia Posterior capsular rupture
   
Other (specify) _____________ Anterior vitrectomy
 
Other (specify) ________________

Biometry K1________D Axial length _____mm
If investigation lens not implanted indicate reason:
K2________D
_________________________________________________
Target postoperative refraction ____________

Signed informed consent obtained: yes   _ _ _ _ _ _ Lens implanted. Place label here:
YY  MM  DD
Date of surgery  _ _ _ _ _ _
Operative report
YY  MM   DD
Implantation
primary            Lens orientation ____________________________
secondary          if secondary, specify reason _____________
_______________________________________________________________________________________ Time to incision closure _________________ minutes
Ophthalmic viscosurgical deviceused        yes     no 
If yes, specify _______________________

Intraocular medication (check yes or no for each) yes no
Signature of investigator
Adrenalin  
 
Acetylcholine
_____________________________    _ _ _ _ __
 
Carbachol
YY  MM  DD
 
Other (specify) ___________________

12 © ISO 2014 – All rights reserved

ISO 11979-7:2014(E)
Table A.5 — Post-operative case report form for anterior chamber lens clinical investigation
Investigator name: _________________________________________ Clinical trial number: _ _ _ _
Patient number: _ _ _ _ Patient initials: ______ Date of birth: _ _ _ _ _ _
YY   MM DD
_ _ _ _ _ _ Cont’d: Other pathology and complications
Post-operative report
YY  MM  DD
present absent
 
Posterior synechiae
Eye right  left 
 
Incorrect lens size
Iris tuck  
Check if the patient is unavailable for this scheduled 
 
Deposits on IOL
examination but continuing in the clinical investigation (
...