Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin P... | NCT04685538

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chloroprocaine 3%	Experimental	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria.	Drug: Chloroprocaine 3%
Tetracaine 0.5%	Active Comparator	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria.	Drug: Tetracaine 0.5%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chloroprocaine 3%	Drug	Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia	Τhe primary endpoint is the number of partecipants in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4 (1 minute after the 3rd drop installation)	Before Intra Ocular Lens (IOL) implantation surgery.

Secondary Outcomes

Measure	Description	Time Frame
Changes in Ocular Symptoms	Changes in ocular symptoms (pain, irritation/burning/stinging, foreign body sensation) will be graded by the patients according to the following scale (0 is the minimum value and 3 is tha maximum value) (0 = absent, 1 = mild, 2 = moderate, 3 = severe) during the study on Visit 1-selection and on visit 4-final	Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed and dated informed consent
Male or female aged≥ 18 years
Senile or pre-senile cataract
Scheduled to undergo cataract surgery in a single eyeat a time (clear corneal self-sealing incisions - phacoemulsification - foldable intra-ocular lens surgery with injector)

Exclusion Criteria:

Combined surgery
Previous intraocular surgery
Previous corneal refractive surgeries less than 6 months before screening
Non Senile or non pre-senilecataract (e.g.: traumatic, pathological or congenital cataract)
Pupillary abnormalities (irregular, etc.)
Iris synechiae
Eye movement disorder (nystagmus, etc.)
Dacryocystitis and all other pathologies of tears drainage system
History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)
Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
History of ocular traumatism, infection or inflammation within the last 3 months
Pseudo-exfoliation, exfoliative syndrome
Prior intravitreal injections within 7 days of the surgery
IOP over 25mmHg under treatment
Best corrected visual acuity < 1/10
Patient already included in the study for phakoexeresis
History of ophthalmic surgical complication (cystoid macular oedema, etc.)
Diabetes mellitus
Surdity
Pakinsondisease
Excessive anxiety
Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, hematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, bradycardia, atrial fibrillation,uncontrolled hypertension: systolic blood pressure over 140 mm Hg, diastolic blood pressure over 90 mmHg) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study.
Known hypersensitivity to sulfonamides products or any of the components of the study medications or to test products Specific exclusion criteria for women
Pregnancy (positive pregnancy test), lactation
Women of childbearing potential without an acceptable effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) until end of the study participation OR
Women not hysterectomized, not menopaused nor surgically sterilized. Exclusion criteria related to general conditions
Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent
Non-compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
Participation in anotherclinicalstudy
Already included once in this study
Ward of court
Patient not covered by the Social Security

Name	Affiliation	Role
Jorge Alio, MD	Vissum Alicante, Calle del Cabañal 1, 03016 Alicante, Spain	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico S. Orsola-Malpighi - Dipartimento testa collo, U.O. Oftalmologia Ciardella		Bologna		40138	Italy

PubMed Identifier	Type	Citation	Retractions
38489057	Derived	Figus M, Giansanti F, Villani E, Alio JL, Janco L, Mercuri S, Camnasio S, Cagini C. Chloroprocaine 3% Gel as a Novel Ocular Topical Anesthetic: Results from a Multicenter, Randomized Clinical Trial in Patients Undergoing Cataract Surgery. J Ocul Pharmacol Ther. 2024 Mar;40(2):117-125. doi: 10.1089/jop.2023.0096.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 12, 2021

Arm/Group Information

ID	Title	Description
BG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
BG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants in Each Treatment Group With a Successful Surface Anesthesia

Τhe primary endpoint is the number of partecipants in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4 (1 minute after the 3rd drop installation)

Posted

Number

participants

Before Intra Ocular Lens (IOL) implantation surgery.

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Units	Counts
Participants	OG000167 OG001171

Title

Denominators

Categories

Anesthesia Success

Title	Measurements
	OG000153 OG001152

Anesthesia NO Success

Title	Measurements
	OG000

Secondary

Changes in Ocular Symptoms

Changes in ocular symptoms (pain, irritation/burning/stinging, foreign body sensation) will be graded by the patients according to the following scale (0 is the minimum value and 3 is tha maximum value) (0 = absent, 1 = mild, 2 = moderate, 3 = severe) during the study on Visit 1-selection and on visit 4-final

Posted

Mean

Standard Deviation

score on a scale

Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Secondary

Objective Ocular Signs

- Objective ocular signs assessed by slit lamp examination, flare, and other objective ocular signs will be graded according to the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The minimum value is 0 and maximum value is 3

Posted

Mean

Standard Deviation

score on a scale

Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Units

Secondary

Fluoresceine

Modification of the basal status evaluated with fluorescein test Approximately 2-3 minutes following fluorescein instillation, corneal staining was to be evaluated in both eyes, using a slit lamp, based on the Oxford scale (grades of 0-5: 0 is normal, 5 is severe abnormal).

Posted

Mean

Standard Deviation

score on a scale

Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Secondary

Endothelial Cell Counts

Modification of the basal status of the Endothelial cell counts evaluated with the specular microscopy

Posted

Mean

Standard Deviation

cell/mm^2

Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Units	Counts
Participants

Secondary

Corneal Thickness

Modification of the basal status of the assesment (Corneal thickness). Measurement of the central corneal thickness was to be performed with a pachymeter

Posted

Mean

Standard Deviation

Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Units	Counts
Participants

Secondary

Best Far Corrected Visual Acuity

Modification of the basal status of the assesment evaluated by LogMAR (Logarithm of the Minimum Angle of Resolution). When using a LogMAR chart, visual acuity is scored with reference to the logarithm of the minimum angle of resolution, as the chart's name suggests. An observer who can resolve details as small as 1 minute of visual angle scores LogMAR 0, since the base-10 logarithm of 1 is 0; an observer who can resolve details as small as 2 minutes of visual angle (i.e., reduced acuity) scores LogMAR 0.3, since the base-10 logarithm of 2 is near-approximately 0.3; and so on.

Posted

Mean

Standard Deviation

LogMAR

Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Secondary

Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy

Modification of the basal status of the assesment. Dilated fundus examination on retina, macula, optic nerve.

Posted

Count of Participants

Participants

Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Units	Counts

Secondary

Intra-ocular Pressure

Modification of the basal status of the assesment. Intraocular pressure (in mmHg) was assessed according to site current practice (air puff or applanation tonometer).

Posted

Mean

Standard Deviation

mmHg

Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Units	Counts

Secondary

Surgeon Satisfaction

Evaluation of surgeon satisfaction. Surgeon satisfaction was assessed through the question "How do you consider the study product global tolerance?", at a scale (a score of 0 is the minimum value with the best outcome and 3 is the maximum value with the worst outcome): (0) Very satisfactory, (1) Satisfactory, (2) Not very satisfactory, (3) Unsatisfactory. It is recorded at V2 and filled in by the surgeon who had performed the study. It is measured at Visit 2.

Posted

Mean

Standard Deviation

score on a scale

day 1 - visit2 (Inclusion visit/Surgery)

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Secondary

Patient Global Satisfaction

Patient global satisfaction at D1 based on a 5-question questionnaire read by a masked observer.

A question read by a masked observer assessed the patient satisfaction about the overall anesthesia during the surgery: "Overall, how satisfied are you with the topical study product used for your local anesthesia during your cataract surgery?" It was measured with 5 possible answers (Likert satisfaction scale): Very satisfied (0), Globally satisfied (1), Neither satisfied nor Unsatisfied (2), Globally unsatisfied (3), Very unsatisfied (4). It was measured at Visit 3.

Posted

Mean

Standard Deviation

score on a scale

day 1 - visit2 (Inclusion visit/Surgery) after the treatment

ID	Title	Description
OG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.
OG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Chloroprocaine 3%	All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.	0	167	0	167	14	167
EG001	Tetracaine 0.5%	All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. Tetracaine 0.5%: Administration: three IMP drops instillation as follow: 1st Drop instillation, then wait for 5 minutes Eye Disinfection, then wait for 2 minutes 2nd Drop instillation, then wait for 1 minute 3rdDrop instillation, then wait for 1 minute Start of Surgery.	0	171	0	171	19	171

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
corneal Dystrophy	Congenital, familial and genetic disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
Conjunctival hemorrhage	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected171 at risk
congiunctivitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
corneal degeneration	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
cornela disorder	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
corneal edema	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected167 at risk EG0012 events2 affected171 at risk
eye discharge	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
hyperesthesia	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected171 at risk
iridocele	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
lens dislocation	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
ocular Hypertension	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
photophobia	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0011 events1 affected171 at risk
keratitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0011 events1 affected171 at risk
deformity	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
pupillary disorder	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
Retinal pigment epitheliopathy	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected171 at risk
general disorder	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected167 at risk EG0010 events0 affected171 at risk
pyrexia	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected171 at risk
Sensation of foreign body	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected171 at risk
edema	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected171 at risk
procedural pain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
blood pressure increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0013 events3 affected171 at risk
Intraocular pressure increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0016 events3 affected171 at risk
trigeminal neuralgia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected167 at risk EG0011 events1 affected171 at risk
devise dislocation	Product Issues	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected171 at risk
cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected167 at risk EG0010 events0 affected171 at risk

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases