EUCTR2013-000292-33-ES进行中（未招募）1 期
Comparative study of the mydriatic effect of Mydriasert vs the use of topical instillation of phenylephrine (10%) and tropicamide (1%) before catarcat surgery.
aura Sararols Ramsay0 个研究点开始时间: 2013年9月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Men and women aged from 45 to 85 years old
- •2. Scheduled to undergo unilateral catarcat surgery. Diagnosis of senil cataract solved by phacoemulsification + intraocular lens implant.
- •3. Patients who understand and sign informed consent.
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •Ophthalmic conditions (elegible eye):
- •1.Combined surgery
- •2. Pupillary abnormalities (irregular,..)
- •3. Very dark iris
- •4. Iris synechiae
- •5. Eye movement disorder (Nystagmus,..)
- •6. Dacryocystitis and all others pathologies of tears drainage system
- •7. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis,….)
- •8. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
- •9. Pseudoexfoliation, exfoliative syndrome
- •10. History of ocular traumatism, infection or inflammation within the last 3 months
- •11. History of uveitis
- •12 Macular thickness >320 micrometers
- •13. History of any other co-existent pathology afecting visual acuity or macular thickness (corneal opacity, AMD, glaucoma, ocular hypertension,...)
- •Ophthalmic conditions (fellow eye):
- •14. Best corrected visual acuity = +1,0 LogMar ó = 35 letters EDTRS or = 20/200 Snellen or = 0,1
- •15. Patient already included in the study for phakoexeresis
- •16. History of surgical complication (cystoid macular oedema...)
- •Ocular and systemic treatments:
- •17. Patients under systemic treatment with mydriatic and/or miotic activity in the last 3 months before the surgery: alpha-adrenergic receptor antagonist, anticholinergic, antipsychotic medication...
- •18. Patients under systemic treatment with corticosteroids or immunosupressive medication in the last 3 months before the surgery
- •19. Patients under systemic treatments with opioids, morphinic medication, MAO inhibitors and/or tricyclic antidepressants in the last 15 days before the surgery
- •20. Patients using topic treatments with mydriatic and/or analgesic activity in the last 15 days before the surgery
- •21. Patients under any other systemic analgesic treatment in the last 7 days before the surgery (except paracetamol)
- •22. Contact lens wearers in the last 7 days before the surgery
- •23. Patients using topic antiinflamatory and antibiotic treatments the day before the surgery
- •24. All the treatments previously mentioned are also forbidden during the follow-up period of the study
- •25. Patients foreseen a change in the not forbidden systemic medication after screening visit
- •Systemic / non ophthalmic conditions:
- •26. Diabetes not controlled,
- •27. Insulin-dependent diabetes
- •28. Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled arterial hypertension etc...) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study.
- •29. Allergic history. Known hypersensitivity to one of the components of the study
- •medications or to test products.
- •30. Allergic rhinitis.
- •31. Pregnancy, lactation.
- •32. Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR Women not hysterectomised, menopaused or surgically sterilized.
- •Non-inclusion criteria related to general conditions:
- •33. Drugs comsumption
- •34. Participation in another clinical study in last 30 days
- •35. Inability of patient and/or relatives to understand the study procedures, and thus inability to give informed consent
- •36. Non compliant patients and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compli
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