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临床试验/NCT04005079
NCT04005079撤回3 期

A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery

Montefiore Medical Center1 个研究点 分布在 1 个国家开始时间: 2019年6月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回
试验地点
1
主要终点
Percentage of intraocular lowering from baseline

研究概览

简要总结

Combined cataract + trabectome surgery is a surgery designed to help lower the intraocular pressure (pressure in the eye) and hopefully reduce the need for topical drops, progression of glaucoma, and/or further glaucoma surgeries. The purpose of this study is to assess whether using pilocarpine, a medication which is FDA approved to induce miosis, (in other words cause the pupil to constrict or become smaller) provides additional benefit to the success of Trabectome and cataract surgery.

详细描述

Glaucoma is the leading cause of irreversible blindness worldwide, and its treatment consists of lowering intraocular pressure (IOP) to prevent damage to the optic nerve and loss of vision. Microincisional glaucoma surgery (MIGS) have become more popular in recent years as less invasive methods than traditional surgeries that effectively reduce IOP and help reduce the medication burden on patients.There are multiple available MIGS procedures, most of which act by increasing trabecular outflow. One such procedure is the Trabectome, which is usually performed in combination with cataract surgery.

Trabectome is an FDA approved device used to perform a trabeculectomy via an internal approach. A strip of 60-120 degrees of the nasal angle trabecular meshwork and the inner wall of Schlemm's canal are removed providing a direct pathway for aqueous outflow from the anterior chamber into the collector channels[2].

Pilocarpine, a parasympathomimetic agent, is a glaucoma medication that works by causing contraction of the ciliary muscle leading to opening of the trabecular meshwork[3]. Due to its frequent dosing requirement and large number of ocular and systemic side effects, pilocarpine has largely fallen out of favor for the treatment of primary open angle glaucoma (POAG), except in patients for whom few other alternatives exist. However, pilocarpine is often used after trabectome surgery.

The rationale for its use after Trabectome procedure is for its miotic effect, which theoretically may prevent the formation of peripheral anterior synechiae. Formation of peripheral anterior synechiae can lead to the closure of the cleft that is generated and the possibility of failure of the procedure. While the theoretical benefit of pilocarpine has been proposed, its actual benefit has never been proven.

In this study, the aim is to evaluate whether Trabecome / Cataract surgery without pilocarpine is non-inferior to Trabecome / Cataract surgery procedure followed by treatment with pilocarpine

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
None

入排标准

年龄范围
30 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age Range: 30 to 100 years old
  • Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with trabectome in a single surgical center

排除标准

  • Patients with previous history of eye surgeries (including laser procedures).

研究组 & 干预措施

Treatment Group

Experimental

2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)

干预措施: Pilocarpine (Drug)

Treatment Group

Experimental

2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)

干预措施: Ofloxacin (Drug)

Treatment Group

Experimental

2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)

干预措施: Prednisolone (Drug)

Control Group

Active Comparator

Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine

干预措施: Ofloxacin (Drug)

Control Group

Active Comparator

Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine

干预措施: Prednisolone (Drug)

结局指标

主要结局

Percentage of intraocular lowering from baseline

时间窗: Up to 1 year

Percentage of IOP drop at 1 month, 6 months and 1 year after surgery.

Number of IOP lowering agents required to achieve goal IOP

时间窗: Up to 3 years

The number of pre and post procedure drops required to achieve goal IOP at 6 months, 1, 2 and 3 years after combined cataract/trabectome surgery in patients treated with post-op pilocarpine vs control

Rate of progression to further glaucoma surgeries.

时间窗: Up to 3 years

Assessment of the rate of progression towards further surgery in patients treated with post-op pilocarpine vs control over a 3 year follow up period

次要结局

  • Frequency of pilocarpine related side effects(Up to 3 years)
  • Frequency of drug discontinuation due to pilocarpine related side effects(Up to 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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