Intervention: Tetracaine
Trial phase: Phase 3
ATC code: C05AD02 | D04AB06 | N01BA03 | N01BA53 | S01HA03
SMILES: CCCCNc1ccc(C(=O)OCCN(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 171
Group description: 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.
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