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临床试验/NCT02681679
NCT02681679已完成不适用

Topical 0.1% Bromfenac Sodium for Intraoperative Pupil Dilation Maintenance and Prostaglandin E2 Inhibition in Femtosecond Laser-assisted Cataract Surgery

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Pupil area measured using ImageJ software A

研究概览

简要总结

Since a new generation of femtosecond lasers became available for cataract surgery in 2009, the use of this image-guided system has provided several benefits, including a reduction in phacoemulsification energy by prefragmentation of the crystalline lens, and the potential advantages of more precise corneal incisions and capsulotomy formation. However, as with any new surgical technique, femtosecond laser cataract surgery also has potential complications. Intraoperative miosis is one of the most common intraoperative complications of femtosecond laser-assisted cataract surgery, with a reported prevalence ranging from 9.5 to 32.0%.8 Significant pupillary constriction necessitates the removal of the anterior capsule flap, fragmented nucleus and remaining cortex, which is potentially associated with a higher rate of surgery-related complications.

详细描述

Since a new generation of femtosecond lasers became available for cataract surgery in 2009, the use of this image-guided system has provided several benefits, including a reduction in phacoemulsification energy by prefragmentation of the crystalline lens, and the potential advantages of more precise corneal incisions and capsulotomy formation. However, as with any new surgical technique, femtosecond laser cataract surgery also has potential complications. Intraoperative miosis is one of the most common intraoperative complications of femtosecond laser-assisted cataract surgery, with a reported prevalence ranging from 9.5 to 32.0%. Significant pupillary constriction necessitates the removal of the anterior capsule flap, fragmented nucleus and remaining cortex, which is potentially associated with a higher rate of surgery-related complications.

Intraoperative miosis may be due to the intraocular effects that occur after femtosecond laser pretreatment. The intraocular tissues may be exposed to laser emissions, and lens proteins can be released into the anterior chamber. Together, these events trigger the release of unwanted cytokines. In a previous study, intraocular prostaglandin concentrations were found to be increased immediately after femtosecond laser pretreatment. Prostaglandins, especially prostaglandin E2 (PGE2), are known to play a role in inflammation-induced miosis.

Preoperative topical treatment with NSAIDs inhibits the release of prostaglandins in response to surgically-induced miosis by suppressing cyclooxygenase, the enzyme that transforms arachidonic acid into prostaglandin precursors. The effectiveness of ophthalmic NSAIDs in preventing miosis has been well documented in conventional phacoemulsification cataract surgery. However, whether this effect is also applicable to femtosecond laser-assisted cataract surgery is unknown. Yeoh has suggested the addition of NSAID eye drops to the dilation regimen during femtosecond laser cataract surgery, but no randomized study has been conducted to support this theory. Given the increasing popularity of femtosecond laser-assisted cataract surgery, the investigators sought to study whether topical NSAIDs might be beneficial in pupil maintenance and PGE2 inhibition during the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • if they were 50 years of age or older and were scheduled to undergo femtosecond laser cataract surgery

排除标准

  • a previous history of intraocular surgery;
  • recent trauma;
  • systemic disease, such as diabetes mellitus; hypertension;
  • the use of systemic or topical NSAIDs within 1 week of enrollment.

研究组 & 干预措施

0.1% bromfenac ophthalmic solution

Experimental

Patients received 0.1% bromfenac ophthalmic solution twice a day for 3 days before surgery.

干预措施: 0.1% bromfenac ophthalmic solution (Drug)

0.1% bromfenac ophthalmic solution

Experimental

Patients received 0.1% bromfenac ophthalmic solution twice a day for 3 days before surgery.

干预措施: femtosecond laser cataract surgery (Procedure)

control physiological normal saline

Placebo Comparator

Patients received control physiological normal saline twice a day for 3 days before surgery.

干预措施: femtosecond laser cataract surgery (Procedure)

结局指标

主要结局

Pupil area measured using ImageJ software A

时间窗: surgery

PGE2 levels measured with an enzyme-linked immunoassay

时间窗: 2 days after surgery

次要结局

未报告次要终点

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haotian Lin

Principle investigator, Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center

Sun Yat-sen University

研究点 (1)

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