Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
Condition: Cataract
MeSH terms: Cataract
Intervention: Chloroprocaine 3%; Tetracaine 0.5%
Intervention description: 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.; 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.
Intervention MeSH terms: Tetracaine; Chloroprocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 338.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cataract; Eye; Chloroprocaine

Summary:

      Randomized clinical trial, multicenter, two-armed, to investigate and compare the clinical
      efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anestheticsin
      phacoemulsification. This prospective, observer masked, randomised, controlled, equivalence
      phase 3 study will be conducted in approximately 4 European Countries. Sintetica intends to
      perform a phase 3 study on patients undergoing cataract surgery to assess the safety and
      efficacy of topical anaesthesia using chloroprocaine gel.
    

Eligibility criteria:

        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 eyeat a time (clear corneal
             self-sealing incisions - phacoemulsification - foldable intra-ocular lens surgery with
             injector)

        Exclusion Criteria:

          1. Combined surgery

          2. Previous intraocular surgery

          3. Previous corneal refractive surgeries less than 6 months before screening

          4. Non Senile or non pre-senilecataract (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

         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.)

         18. Diabetes mellitus

         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.

         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