Status:
COMPLETED
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
Lead Sponsor:
Sintetica SA
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. ...
Detailed Description
Prospective,randomized, multi-center, active-controlled, masked-observer, parallel-group, competitive equivalence study. The study has been designed to assess the equivalence of chloroprocaine 3% gel ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2021
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT04685538
Start Date
September 9 2020
End Date
March 9 2021
Last Update
January 18 2023
Active Locations (27)
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1
Policlinico S. Orsola-Malpighi - Dipartimento testa collo, U.O. Oftalmologia Ciardella
Bologna, Italy, 40138
2
A.O. Mater Domini di Catanzaro - U.O. Oculistica
Catanzaro, Italy, 88100
3
A.O.U. Careggi di Firenze - Dipartimento neuromuscoloscheletrico e organi di senso, reparto di oculistica
Florence, Italy, 50134
4
"IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano" - Dipartimento di chirurgia, U.O. Oculistica
Milan, Italy, 20122