EUCTR2019-001660-30-SK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.
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
- •To be enrolled in this study, subjects must fulfil all these 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
排除标准
- •Patients fulfilling at the selection visit ONE OR MORE of the following exclusion criteria will not be enrolled in the study:
- •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.)
- •Other criteria are defined in the study protocol (Systemic/non ophthalmic exclusion criteria, Specific exclusion criteria for women, Exclusion criteria related to general conditions, Exclusion criteria related to previous and concomitant medications / non-product therapies).
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