Study to evaluate and compare the efficacy of local anesthetics Chloroprocaine 3% gel and Tetracaine 0.5% eye drops in cataract surgery.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 342

Inclusion Criteria

1.Signed and dated informed consent
2.Male or female aged > = 18 years
3.Senile or pre-senile cataract
4.Scheduled to undergo cataract surgery in a single eye at a time (clear corneal self-sealing incisions - phacoemulsification – foldable intra-ocular lens surgery with injector)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 228
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 114

Exclusion Criteria

Ophthalmic exclusion criteria
- Surgical conditions in the eye to be operated:
1.Combined surgery
2.Previous intraocular surgery
3.Previous corneal refractive surgeries less than 6 months before screening
- Non-surgical conditions in the eye to be operated:
4.Non Senile or non pre-senile cataract (e.g.: traumatic, pathological or congenital cataract)
5.Pupillary abnormalities (irregular, etc.)
6.Iris synechiae
7.Eye movement disorder (nystagmus, etc.)
8.Dacryocystitis and all other pathologies of tears drainage system
9.History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)
10.Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
11.History of ocular traumatism, infection or inflammation within the last 3 months
12.Pseudo-exfoliation, exfoliative syndrome
13.Prior intravitreal injections within 7 days of the surgery
14. IOP over 25mmHg under treatment
- Ophthalmic conditions in the contra-lateral eye:
15. Best corrected visual acuity < 1/10
16. Patient already included in the study for phakoexeresis
17. History of ophthalmic surgical complication (cystoid macular oedema, etc.)
- Systemic/non ophthalmicexclusioncriteria
--General history:
18. Diabetesmellitus
19. Surdity
20. Pakinsondisease
21. Excessive anxiety
22. 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.
--Allergic history:
23. Known hypersensitivity to sulfonamides products or any of the components of the study medications or to test products Specific exclusion criteria for women
24. Pregnancy (positive pregnancy test), lactation
25. 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
26. Women not hysterectomized, not menopaused nor surgically sterilized.
- Exclusion criteria related to general conditions
27. Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent
28. Non-compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
29. Participation in anotherclinicalstudy
30. Already included once in this study
31. Ward of court
32. Patient not covered by the Social Security

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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