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临床试验/NCT03851172
NCT03851172Unknown2 期

Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery

Assiut University0 个研究点目标入组 75 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
75
主要终点
Prevention of miosis during cataract surgery

研究概览

简要总结

This study aim at determining the efficacy of Nepafenac and Ketorolac in obtaining adequate intraoperative mydriasis and preventing miosis during cataract surgery. It also compare the efficacy of both Nepafenac versus Ketorolac, and determine the more effective agent in preventing miosis during cataract surgery. The investigators try to determine if the effect of preoperative NSAIDs agents use would show a financial benefit, or this manoeuvre would add a financial load on the patients who are candidate for cataract surgery.

详细描述

Maintaining adequate mydriasis is one of the most important prerequisites during both extracapsular cataract extraction and phacoemulsification intervention. The importance of intraoperative maintenance of mydriasis arises from the necessity for the surgeon to insert intra-ocular lens in the posterior chamber of the eye. It is now well established that non-steroidal anti-inflammatory drugs (NSAIDs) reduce intraoperative miosis during cataract surgery. Topical Flurbiprofen, Indomethacin and Diclofenac with and without intraoperative epinephrine are the commonest topical non-steroidal eye drops with which nearly all publications in the literature studied the prevention of intraoperative surgery-induced miosis. In addition, Diclofenac was found to be the most effective NSAIDs agent in maintaining intraoperative mydriasis.

More recently, evidence that some NSAIDs, namely ketorolac and Flurbiprofen, may have a role in preventing pseudophakic cystoid macular oedema.

Patients whom eyes are pre-treated with some NSAIDs, especially diclofenac, shows a statistically significant reduction in the degree of postoperative inflammation (e.g., redness, pain and itching) on the first post-operative day. On the contrary, Thaller et al found, in his study at 2000, that no statistically significant difference in the postoperative redness, pain and cells in the anterior chamber.

Administration of Adrenalin in the anterior chamber fluid is found by several studies to be more effective in maintaining intraoperative mydriasis than preoperative treatment with NSAIDs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

盲法说明

Allocation concealment will be achieved by masking the bottles of the different agents which will be used in the study. All agents will be added to non-labeled bottles, then they will be labeled by the supervisor (who will not participate in eye drops administration) as bottle (1), bottle (2) and bottle (3). The most junior researcher will be responsible for the eye drops administration, for whom the different agents are not known.

入排标准

年龄范围
2 Days 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cataract who are candidate for cataract surgery

排除标准

  • Patient with other ocular comorbidities rather than cataract,
  • Patients with history of trauma.
  • Patients on Corticosteroid drops treatment.
  • Previous intraocular surgery.

研究组 & 干预措施

Nepafenac and cyclopentolate

Experimental

Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery

干预措施: Nepafenac Ophthalmic (Drug)

Nepafenac and cyclopentolate

Experimental

Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery

干预措施: Cyclopentolate Ophthalmic (Drug)

Ketorolac and cyclopentolate

Experimental

Ketorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery

干预措施: Ketorolac Ophthalmic (Drug)

Ketorolac and cyclopentolate

Experimental

Ketorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery

干预措施: Cyclopentolate Ophthalmic (Drug)

Cyclopentolate and saline 0.9%

Placebo Comparator

Cyclopentolate eye drops two times before surgery and saline 0.9% eye drops two times before cataract surgery

干预措施: Cyclopentolate Ophthalmic (Drug)

结局指标

主要结局

Prevention of miosis during cataract surgery

时间窗: 30 minutes

The prevention of intraoperative miosis during cataract surgery after preparation by the different eye drops and cyclopentolate

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omnia Ahmed Mahrous Sayed

Resident at ophthalmology department

Assiut University

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