EUCTR2019-001660-30-IT进行中（未招募）1 期
A prospective, observer-masked, randomized clinical trial to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anesthetics in phacoemulsification. - CHL.3/01-2019/M
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 342
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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
研究者
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