EUCTR2004-005287-24-AT进行中（未招募）不适用
Effect of diclofenac-sodium, unpreserved diclofenac-sodium or ketorolac on the inflammatory response after cataract surgery
niv.-Kl. f.Augenheilkunde und Optometrie Wien0 个研究点目标入组 140 人开始时间: 2005年5月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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
- •Male/Female patients suitable for phacoemulsification cataract surgery
- •Aged 40-90 years
- •Able and willing to give 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A)Pre-operative: History
- •1.Presence of pre-proliferative and proliferative diabetic retinopathy with or without diabetic maculopathy
- •2.Patients with severe systemic dysfunction
- •3.Ocular surgery or laser therapy, especially if recent, in the operative eye
- •4.Hypersensitivity to: Diclofenac-sodium, Ketorolac-Trometamol , Prednisolon-21-acetate or any ingredient of the concomitant or study medication
- •5.Recent treatment with ophthalmic local or systemic anti-inflammatory drugs
- •6. History of intraocular inflammation / uveitis
- •B)Pre-operative: Examination
- •1.Ocular malformations like microphthalmia
- •2.Significant anterior segment ocular disease involving the cornea or uvea
- •3.Concurrent inflammatory/infective eye disorder e.g. conjunctivitis, episcleritis, blepharitis other than mild seborrhoic blepharitis etc.
- •4.Severe dry eye syndrome (needing ocular lubricants more than 6 times per day)
- •5.Cataract secondary to ocular injury/inflammatory eye disease
- •6.Ocular hypertension or glaucoma under treatment with topical medications other than topical beta-blockers used for at least 28 days prior to study admission
- •7.Intra-ocular pressure > 26mm Hg with or without treatment
- •8.Any other disease e.g. pseudo-exfoliation in the operative eye which makes the subject unsuitable for the trial
- •C)Surgery not performed according to the standard operating procedure
- •D)Intra-operative complications and medication:
- •1.significant corneal, iris or vitreal damage
- •2.excessive cortical remnants
- •3.significant anterior chamber bleeding
- •4.intraocular lens not implanted or significant dislocation of the implant
- •5.any medication other than those listed in the standard operation procedure for cataract surgery
- •E)Post-operative complications on day 1:
- •1.wound dehiscence/iris prolapse requiring re-suturing
- •2.fibrin in the anterior chamber
- •3.severe intraocular inflammation, infection or bleeding
- •4.intraocular lens dislocation i.e. optical center of the lens more than 2mm out of the optic axis
- •5.any other complications e.g. severe conjunctival chemosis on day 1 in the operative eye, considered by the investigator to be adequately significant to interfere with the trial
- •F)Concomitant medication (added post-operative)
- •1.Any topical ophthalmic medication in the operative eye other than the study medication, artificial tear substitutes and topical antibiotics.
- •2.Anti-inflammatory systemic medication; however, the use of OTC anti-inflammatory and analgesic drugs such as acetyl salicylic acid and paracetamol for minor conditions
- •(e.g. headache) is acceptable if not more than 2000 mgs per week.
- •1.Non compliant patients (e.g. not willing to attend the follow up visits)
- •2.Pregnant or lactating patients or of childbearing potential.
- •3.Contact lens wearer during the treatment period
- •4.Known substance abuse (including alcoholism)
- •5.Participation in another clinical trial
- •6.Mentally handicapped patients
- •7.Judged by the investigator to be unsuitable for the study
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